10 Best Diagnostic Solution Providers in 2023

March Issue 06 2023 Clinical Benefits The Importance of Personalized Healthcare in Diagnostics Fundamental Aspects

10 Best

Diagnostic Solution

Providers

in 2023

Diagnostics are Aided

by Digital Technologies

Mike Martens Scientific Business Executive Future Diagnostics

Future

Diagnostics

Gifting Transparent, Accurate and Reliable Diagnosis in the IVD Industry

Be er Health and a better way of life.

Editor’s

Note

E ective Patient Care Services in Diagnostic Solutions

E

ffective patient care services are crucial in diagnostic solutions, as they ensure that patients receive timely, accurate and appropriate care. In this note, we'll explore some of the key elements of effective patient care services in diagnostic solutions, and how they can help improve patient outcomes.

One of the most important elements of effective patient care services in diagnostic solutions is timely diagnosis and treatment. This means ensuring that patients receive diagnostic tests and procedures on time and that they receive appropriate treatment as soon as possible after diagnosis. Timely diagnosis and treatment can help prevent the spread of infectious diseases, reduce the risk of complications and improve patient outcomes.

Effective patient care services in diagnostic solutions also require coordination of care. This means ensuring that patients receive appropriate care from all the healthcare providers involved in their care, including diagnostic specialists, primary care physicians, and other specialists as needed. Coordination of care can help prevent errors and delays in diagnosis and treatment and can improve patient outcomes.

Finally, effective patient care services in diagnostic solutions should be patient-centered. This means ensuring that patients are treated with respect and dignity, and that

their preferences and values are taken into account when making decisions about their care. Patient-centered care can help improve patient satisfaction and engagement, and can lead to better health outcomes.

In conclusion, effective patient care services are essential in diagnostic solutions. By ensuring timely diagnosis and treatment, access to information, patient education and support, coordination of care, and patient-centered care, healthcare providers can help improve patient outcomes and ensure that patients receive the best possible care. As technology continues to evolve, we can expect patient care services in diagnostic solutions to become even more effective and patient-centered.

In Insights Care's new edition, 10 Best Diagnostic Solution Providers 2023 we walk you through the companies which are transforming the healthcare industry with their experience and efficiency, prioritizing the needs of the customers.

Hope you have a good read!

-Pooja Shah

Cover

Story

08 Future Diagnostics Gifting Transparent, Accurate, and Reliable Diagnosis in the IVD Industry

20

Clinical Benefits The Importance of Personalized Healthcare in Diagnostics

Articles 32

Fundamental Aspects

Diagnostics are Aided by Digital Technologies

Ctts Ctts 16 Acarix

Providing Ease and Peace through Innovative Medical Solutions

28 CancerCenter.AI

Transitioning Healthcare from a Quagmire to the Future Sustainable

24 AccuGenomics

A Precision Diagnostics Company That Enables Accurate And Standardized Molecular Tests To Discover The True Underlying Biology From Next Generation Sequencing

36 Imagion Biosystems Ltd

Providing a 'Breakthrough' Technology to help Transform Cancer Care

Editor-in-Chief Merry D'souza

Senior Editor Anish Miller

Managing Editor Pooja Shah

Assisting Editors Saloni, Shreyasi

Visualiser

Art & Design Head

Co-designer

Art & Picture Editor

David King

Mrunalinee Deshmukh

Paul Belin

Sonia Raizada

Business Development Manager Amy Jones

Marketing Manager John Smith

Business Development Executives Sarah Wilson, John Smith, Alex Vincent

Sales Executives Kelli, Bill, Anna

Technical Head Jacob Smile

Assistant Technical Head Prachi Mokashi

Technical Consultants David, Robert

Digital Marketing Manager Alina Sege

Assistant Digital Marketing Manager Renuka Kulkarni

SME-SMO Executives Gemson

Research Analyst

Circulation Manager

Eric Smith

Tanaji Fartade

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10 Best Diagnostic Solution Providers in 2023

Company Acarix AB acarix.com

AccuGenomics, Inc accugenomics.com

BriaCell briacell.com

Cancer Center cancercenter.com

Co-Diagnostics codiagnostics.com

Future Diagnostics future-diagnostics.nl

Imagion Biosystems, Ltd

imagionbiosystems.com

Lipotype lipotype.com

Lumos Diagnostics lumosdiagnostics.com

Omega Diagnostics omegadx.com

Featuring Person

Description

Helen Ljungdahl Round President and CEO

Acarix AB is a Swedish medical device company that innovates solutions for rapid AI-based Coronary Artery Disease (CAD) rule-out.

Nick Lazaridis President

AccuGenomics, Inc is a developer of a unique spike-in control technology that dramatically improves the accuracy and performance of clinical sequencing tests.

Charles Director

BriaCell is a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer.

Piotr Krajewski CEO and Co-founder

Cancer Center is commitment to high-quality, compassionate care that puts patients first.

Cameron Gundry Communication

Co-Diagnostics is passionate about providing the most robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications, especially to those regions where pricing is paramount.

Mike Martens Scientific Business Executive

Future Diagnostics are laboratory professionals that invent, create and validate in-vitro diagnostic tests and products.

Bob Proulx CEO

Imagion Biosystems, Ltd is dedicated to providing tools to find and eliminate cancer.

Henri Ded Communication Officer

Lipotype provide Lipidomics analysis service to help clients achieve their research goals.

Kepa Oyarbide Director

Lumos Diagnostics specializes in rapid, cost-effective and complete point-of-care (POC) diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions.

Nicky Ester OP

Omega Diagnostics is an international diagnostics testing business that is passionate about improving lives around the world by accurately informing health decisions.

Cover

Story

Mike Martens Scientific Business Executive Future Diagnostics

Future

Diagnostics Gifting Transparent, Accurate and Reliable Diagnosis in the IVD Industry

Our development professionals investigate how to detect specific biomarkers, choose the right reagents and provide the necessary protocols and process documentation to make the best possible IVD products.

10 Best Diagnostic Solution Providers in 2023

I

n the contemporary times of the 21st century, success and excellence are marked by effective communication and networking. For any business, this means creating avenues for healthy, transparent, continuous and instant communication to enable ease of access for its customers.

The sequences of this strong bond result in trust and happy customers that maximize brand reliability and unique positioning in the competitive market.

This rightly targets the demands of the consumer and ensures that the customer is the king.

One such company curating this experience for its clients is Future Diagnostics. It has been gifting reliable diagnostics tests in the IVD industry and immunoassay performances for the past twenty-five years. It also contributes to costeffective healthcare that works worldwide, providing its clients with IVD tests that make state-of-the-art medical diagnostics possible, performed with dedication, integrity, transparency, and flexibility.

The system is balanced and supervised under the leadership of its Scientific Business Executive – Mike Martens, who is also one of the founders of the company and is responsible for doing business development with established customers and potential new customers.

Transitioning in the early stages of his career, he grew to be a scientist and later as an R&D manager and guided the development of several assay development projects, both manual as well as automated assays.

Mike and the team, together, are reforming diagnostic experience for their clients, devising a futuristic experience the industry is about to offer.

Let us dive in to read more about how it has been building this for the last twenty-five years!

Marking the Beginning Future Diagnostics was founded in 1997 and is celebrating its 25th anniversary this year. The six people that started Future Diagnostics all came from the R&D team of a USbased diagnostics company, which had a European HQ in the Netherlands.

In early 1997, the US-based company decided to transfer all its manufacturing and R&D activities to the US. Two people from the R&D team decided to start a new company

and focus on what they had expertise in, which was performing immunoassay development and offering this as a service to the In Vitro Diagnostics (IVD) industry.

This was the start of Future Diagnostics. Twenty-five years later, this is still the company's core business, directing quality through its process to supply the sector with good and lasting products.

Providing Accurate and Research-based Services The Future Diagnostics team are laboratory professionals that invent, create and validate in-vitro diagnostic tests and products. A service provider and a development partner to biotech companies in the global IVD medical device market.

Mike and his team understand that in the medical world, having the ability to accurately measure biomarkers is essential for diagnosing diseases. These measurements are done manually but also on automated platforms/analyzers.

As per Mike's observations, when an analyzer for IVD testing is developed, it will not automatically measure the desired biomarkers, and that's where he says that Future Diagnostics appears.

Building on this information, he says, "Our development professionals investigate how to detect specific biomarkers, choose the right reagents and provide the necessary protocols and process documentation to make the best possible IVD products."

Besides full assay development services for manual assays, automated assays, Point of Care assay, and Companion Diagnostics assays, they also provide services in the following areas: Conjugation Services Lyophilization Services (accusphere technology) Analytical Performance Studies (Verification and Validation) Ÿ Multiplex Array Services Ÿ Small Scale Manufacturing Services Ÿ Ÿ Ÿ

Ensuring Transparent Client Communication Mike shares, "Every single one of our customers will agree: by working with our proven step-by-step action plan, we control every single part of the product development process."

They have developed four stages to reach the set goals: Ÿ Ÿ Ÿ Ÿ

Contract and Definition Proof of Concept and Feasibility Design and verification Production and validation

These steps are the pillars that guide the Future Diagnostics team and keep them focused to adequately and efficiently run their processes without losing precious time and focus.

Mike mentions that a project that is brought to them is always supervised by two of their experts. He further says, "The expert responsible for the technical part of the IVD

product development process is constantly observing and controlling the terms of the agreement. Our second expert controls the set time frame, deliverables and overviews the costs."

To enhance the benefits for their clients, during the development process, they regularly report the progress of the project to them. Also, their SharePoint environment enables their clients to have a real-time view of the progress. He believes, "It is vital to have transparent communication between us and our client to keep the development process efficient thereby saving time and costs."

Assuring Quality and Perfection For Future Diagnostics, Mike says that, the vast experience has provided them with an elaborate knowledge of numerous analyzers and technologies. He proudly shares, "After all, we have been in business for 25 years and have seen a variety of analyzers and technologies during that time." Their familiarity with various instruments and technologies ensures they can start quickly and efficiently without losing precious and valuable time learning.

In the last years we have been able to proof this even more by setting up a SharePoint environment in which our customers are able to "look over our shoulder" in respect to the activities that we perform.

He conveys that the company's clients can always count on high-quality service and, consequently sophisticated validated tests for their market. Mike believes that this can only be guaranteed through the professionalism and knowhow of the people and through using only the best available products.

For this, all of their procedures are monitored and recorded by the advanced quality management systems, which comply with existing legislation. He asserts, "Our quality professionals leave nothing to chance. In our opinion, perfection is our greatest asset." This enables them to use their time as efficiently as possible while avoiding wasting valuable time correcting errors.

Despite the unpredictability of biomaterials at times, they strive for minimal waste and maximum results. He says, "IVD development by Future Diagnostics is one crucial step of many to introduce your product to the market. Our commitment is key!"

This is driven by their constant upgradation and partnership with emerging innovations.

Fostering Stronger Ties with Technological Aid As per Mike, the company and its team have always communicated that they perform their services in an open and transparent way.

Expressing on the transparent workflow,, Mike explains, "In the last years we have been able to proof this even more by setting up a SharePoint environment in which our customers are able to "look over our shoulder" in respect to the activities that we perform."

Furthermore, the Teams meetings they have set up are a reasonable alternative for face-to-face meetings and are much better compared to telephone conferences for them and their clients. Over the years, this professional commitment has also enabled them to navigate through troubled waters.

The Founder's Story Mike Martens is one of the two founders of Future Diagnostics. He started his career in the IVD industry in 1991, as a scientist, developing immunoassays for the earlier mentioned US-based diagnostic company.

His initial activities were really hands-on, performing assay development work on the lab bench. The first immunoassay that he developed was an assay to measure erythropoietin (EPO). From a scientist, he became an R&D manager and guided the development of several assay development projects, both manual as well as automated assays.

When the founders started Future Diagnostics in 1997, he became the CTO of the company. After the retirement of his colleague in 2012, he became the Managing Director. Now, he is the Scientific Business Executive responsible for business development with established and potential new customers.

But, as Future Diagnostics, he informs that the organization is focused on the development of an assay that fulfils the technical requirements of its customers. He points out, "This is our focus."

By making alliances with companies that focus on regulatory and clinical requirements, it can support their customers with a one-stop shop approach by means that Future Diagnostics is also taking the regie of the other activities, creating opportunities for themselves and their clients.

He finds it essential to spread this "happy customer" attitude to future generations of entrepreneurs.

Creating Opportunities Amidst Challenges

Channelling the Journey of Young Minds

Sharing insights on the current challenges, Mike discusses, "From a regulatory point of view IVD, companies have to show high standards for all their on-market products. This includes not only a vast variety of technical performance data but also clinical performance data based on several clinical studies."

Being an expert in the field and an experienced leader in the industry, Mikes suggests that with respect to the activities that an aspiring entrepreneur performs for customers, the individual has to stay focused on that activity. He thinks that in such a way, one can improve their services every time and strive for product leadership.

To help them carve a focused path, Mike advises, "Take the comments from your customers seriously and improve your services towards them every time. Make sure that they feel themselves as a valued customer. This way, you create happy customers, and happy customers come back for your services."

For him, it is very important that new staff is trained in a proper way and does get experience in the line of services as, without it, he fears that they would end up with a large staff that has a diluted knowledge of assay development, which is crucial to them since they want to achieve product leadership. He says, "This is very important to us and we monitor this carefully."

Planning for Future Growth In Mike's opinion, since Future Diagnostics is a company that performs its services based on its experience/knowledge, the team is very careful that they do not grow too quickly.

Take the comments from your customers serious and improve every time your services towards them. Make sure that they feel themselves as a valued customer. This way you create happy customers and happy customers come back for your services.

Mike further elaborates, "Since we are also involved in Proof of Concepts of new technologies, i.e., photonic sensor platforms, we are able to expand our services and capabilities in new innovative areas that have the potency to become next generation detection technologies in the IVD industry."

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Ms Helen Ljungdahl Round President and CEO Acarix

10 Best Diagnos c Solu on Providers in 2023

Providing Ease and Peace through Innovative Medical Solutions

As a sign of change, organizations have worked with the common goal of achieving the best outcome for the patient, and overall value for the healthcare system has been out of focus. One such organization, Acarix is touching millions of hearts with its groundbreaking AI technology which helps detect heart sound abnormalities, such as coronary murmurs and many more in less than ten minutes.

As President and CEO at Acarix, Ms Helen Ljungdahl Round has rapidly clarified the strategy, refocused the company efforts on the commercialization in the US, strengthened the Global Management Team to drive the global performance, and hired a top talent women US leadership team to drive the growth in the US. Below are the highlights of Ms Helen's interview with Insights Care: Please brief our audience about your company, its USPs, and how it is currently positioned as a reliable firm in the healthcare sector.

Acarix is a Swedish medical device company that innovates solutions for rapid AI-based rule out of Coronary Artery Disease (CAD). The CE approved and FDA DeNovo cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and is designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures.

The CADScor®System calculates a patient-specific CAD score non-invasively in less than ten minutes and can help

“

I am excited about leading a company that is utilizing acoustic engineering and AI to rapidly assess patients with chest pain and help determine if they have CAD. I believe that we can impact not only cardiovascular health care but also provide patients with a rapid response and peace of mind.

“

I

nnovation in the healthcare niche means innovation in the complete lifecycle of medical devices from conceptualization to the end of life of that device. This created an opportunity for the medical industry to leapfrog and make fundamental changes.

rule out more than one-third of patients with at least 96% certainty of not being sick (in a population with approx. ten per cent CAD prevalence). Acarix is listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX).

Shed some light on your offerings and how they impact the industry and your clients?

Our mission is to touch millions of hearts with CADScor®System, our groundbreaking AI-based technology for the acoustic assessment of coronary artery disease (CAD), and aid to rule out those that have low risk.

Our vision is that everyone that needs a CADScor®System assessment should have access. By doing so, we can reduce

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How do you envision scaling your organization's operations and offerings in 2022 and beyond?

Our vision is to create a paradigm shift in the early diagnosis and assessment of cardiac and vascular diseases.

Overall, we are working on ensuring that everyone, be it a health care professional or a patient who wants or needs a CADScor®System assessment, can get one promptly. We recognize that this is far from where we are today, but given the technology in the CADScor®System, this is the right vision for us to be operating under and to deliver the expected growth.

the diagnostic burden on individuals, provide peace of mind, as well as help drive efficiency across the overall cardiac health care systems. There are one million people with chest pain seeking medical attention each day. The difficulty is to determine whether this is related to the heart or not, and many go through multiple diagnostic tests, some also invasive.

The troubling fact is that nine out of ten assessed do not have CAD. In just ten minutes, the CADScor®System can instead rule out CAD in those presenting with stable chest pain and suspected CAD with at least 96% certainty.

Being an experienced leader, share your opinion on how the adoption of modern technologies and platforms has impacted the diagnostics space and how is your company riding the technology wave?

Modern technology and innovation will continue to improve healthcare and patient outcomes. I am excited about leading a company that utilizes acoustic engineering and AI to rapidly assess patients with chest pain and help determine if they have CAD. Acarix is at the forefront of this wave – we have the technology to support clinicians in their diagnosis of patients, and healthcare systems in driving efficiencies and cost reductions. Still, most importantly, we provide rapid answers and hopefully peace of mind for the millions of people with chest pain and suspected CAD. What would be your advice to budding entrepreneurs who aspire to venture into the healthcare space?

Lean in and focus. Focus on unmet needs, developing innovative technologies to address the needs. Understand the problem you're trying to solve. Design the products with the end in mind. Think big, develop a clear strategy, execute with purpose, and track and prioritize ruthlessly.

We are systematically moving from a start-up to a scale-up; we are at an inflection point and focusing on scaling up our operations, our commercial, and our R&D capabilities to meet important cardiovascular and other unmet medical needs and grow the company through organic and commercial partnering.

Please give us a few testimonials of your clients/customers and a list of awards/recognitions that accurately highlight your organization's position in the market.

Robin Karas, President Bio-Rythms Inc: "I am delighted to be working with Acarix on introducing the CADScor System in Louisiana and Mississippi. The novel AI-based acoustic technology brings significant value to physicians assessing chest pain patients. I have been in Cardiology sales for 40 years, and not since balloon angioplasty has, I seen such a game-changing technology. The initial interest and response from physicians have been very strong."

Prof. Dr Andreas Götte, Professor of Medicine and Chief of the Department of Cardiology and Intensive Care Medicine at the St. Vincenz Hospital in Paderborn, Germany "Usually, we have a very short time period to do all diagnostic tests. We know from the latest guidelines that a treadmill test is not appropriate for ischemic assessment.

For this reason, we need imaging technologies like CT or echo, or MRI which are not available for this large volume of patients. It's very easy to use CADScor®System, you just need four times eight seconds of non-breathing, and you can assess the flow in the coronary arteries. I think it's very helpful to be used in patients where you want to rule out the presence of coronary artery disease or coronary artery sclerosis.

Ms Kelly Kolodney, Patient Perspective, USA "I was having this tightness feeling around my chest for the

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A Highly Empowered Clinical Leadership Ms Helen Ljungdahl Round is a highly accomplished execu ve with more than 25 years of leadership experience across strategy, business management, marke ng and sales in both the pharmaceu cal and medical technology industry. Her accomplishments span numerous therapeu c areas, product life cycles and geographic areas.

Her most recent posi on as CEO of Amnicell, a biotech start-up based in New York City, has prepared her well for this new opportunity, along with previous roles as Senior Vice President of Global Marke ng and Business Development for GN Hearing in Denmark and many execu ve leadership posi ons of increasing responsibility at Merck & Co, Inc, working in North America, EU, the Middle East/Africa, La n America, and Asia.

She is recognized as a strong commercial leader that has consistently built high-performing teams and organiza ons and delivered profitable and sustainable business results.

last several weeks. At night sometimes it would get really bad. My husband – who is not an alarmist – said, "we'd better go to the ER and see what's going on, this keeps happening." Not long after that I had an opportunity to get a CADScor System test.

When that was done – it was such an easy and simple procedure – it took no more than maybe 10 to 15 minutes – I got my CAD-score and it was 13. It just gave me this sense of peace and relief that it wasn't my heart. I was so grateful that I was able to do that without having to go through multiple different kinds of expensive tests to come to the same conclusion. I was just amazing."

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Clinical Benefits

The Importance of

Personalized

Healthcare

in Diagnostics

P

ersonalized Medicine (PM) moves at the same pace as data and technology and calls for essential changes in healthcare. New players are participating, providing impulse to PM. We review the conceptual foundations for PM and personalized healthcare and their evolution through scientific publications where a clear definition and the features of the different formulations are identifiable.

Over time, new paradigms of Medicine and healthcare have been defined. An approach genuinely favors the single person is technically feasible, economically valuable, and culturally, ethically, and socially accepted. With time, it will become more and more unethical and uneconomic to deliver non-personalized services considering the inefficacy, side effects, and high costs of some standard treatments.

Principles of this personalization continuum have been traced from scientific publications and complemented with an assessment of strategic documents released by European

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fora, which have a focus on personalized Medicine (PM), such as the International Consortium for Personalised Medicine Let's have a look at Personalized Healthcare and learn more about it

needs" (2015/C 421/03). Over time, PM has been a catchall term frequently used synonymously with genomic Medicine. Since President Obama launched the Precision Medicine Initiative (PMI) in 2015, these ideas have been used to determine which treatments based on genetic, environmental, and lifestyle factors are best for which patients.

Early Approaches to Personalized Medicine PM is not only about the mere individualization of Medicine, formulated by Hippocrates over 2400 years ago, but also about the higher precision of diagnosis, therapy and prognosis that can ideally be tailored to the single patient and citizen. Principles of this personalization continuum have been traced from scientific publications and complemented with an assessment of strategic documents released by European

Hood's concept of Predictive, Preventive, and Personalized Medicine (PPPM or 3P Medicine) was presented as the beginning of a new era in 21st-century Medicine as the potential benefits of genomics, and PM began to emerge.

Next Step of PM

The current evidence-based approach means that individual patient diagnosis, treatment, and care options are determined by medical guidelines based on biomedical and clinical research and the results of clinical studies. With this strategy, clinical, biological, biotechnological, and computational biology expertise are combined to aid in formulating and validating the most effective treatment and comprehending disease mechanisms.

The ability to measure, store, and health-related data has reached unprecedented capacity, while public and private investments are flourishing. The abundance and affordability of genetic testing currently available, the abundance of e-health and m-health tools in clinical practice, and wearable devices offer the possibility to measure, collect, and share biological and lifestyle data easily. The term "3P Medicine" was used in the scientific literature primarily concerning genomics, pharmacology, and systems biology. Smartphones and watches record social networks and behavior.

Individual-specific individualized approaches: The socalled "network medicine," which emerged from the previous phase's computational biology, emphasizes early and subtle signs of deviation from homeostasis, patients' sensitivity and awareness, and personal preferences. The personalized approach is tailored to patients' characteristics, such as the genome, microbiome, epigenetic (precision), and lifestyle parameters.

In conjunction with electronic health records, all of this can provide an overview of health outcomes at various stages of life, identify health risks in individuals, and improve health outcomes. A new healthcare system configuration appears conceivable; we have dubbed it the next PHC as it develops. We can anticipate personalized, predictive, preventive, participatory, and person-centered care approaches in healthcare, just as they did in Medicine.

Evolving PM and its aspects

To conclude,

The term PM first appeared in published works in 1999, highlighting how the new technical advances in predicting health risks, tracking disease development, and predicting response to therapy could enable tailored approaches to care. Evolving PM and its aspects Although the knowledge behind it was already observable in clinical practice,

This approach is becoming increasingly necessary, particularly in light of global healthcare emergencies, which have demonstrated their ability to undermine social and economic stability worldwide. With personalized Medicine, doctors can provide patients with individualized treatments based on their characteristics, resulting in better outcomes and enhanced quality of life.

The European Council Conclusion on Personalised Medicine for Patients adopted the definition that "Personalised medicine relates to the broader concept of patient-centered care, which takes into account that, in general, healthcare systems need to better respond to patient

In the years to come, personalized healthcare will become even more important as medical research and technology advance, revolutionizing the healthcare industry and improving patient care.

- Shreyasi Shelke

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10 Best Diagnostic Solution Providers in 2023

AccuGenomics A Precision Diagnostics Company That Enables Accurate And Standardized Molecular Tests To Discover The True Underlying Biology From Next Generation Sequencing

W

aking up one morning and discovering that the world is hit by a pandemic virus can be breathtaking, but stepping back one must recognize the impressive ability of nature; with a long single-stranded molecule replicating inside the human genomic system, to put the world in perils of global lockdown.

Towards understanding the significance of genomic research, and perhaps partially attributed to increased social awareness from Covid-19, molecular diagnostics has been elevated and highlighted in society and is now more widely recognized and understood by those outside the core of the industry. Driving this change, many companies have facilitated groundbreaking clinical solutions while fostering an era of scientific revolution. Trailblazing such entrepreneurial spirit that transforms the world for the better, AccuGenomics is exemplifying the true meaning of "technology leadership."

As a clinical genomics leader, the company is positioning it's gold-standard NGS standardization technology with the goal of helping millions with more accurate healthcare insights. Standing as the guiding light on the transformational path of AccuGenomics is company President Nick Lazaridis, Ph.D. Realizing the technological marvels of the company, we at Insights Care met Nick to learn more about AccuGenomics' present solutions and its future roadmap ahead.

biomarkers, increasing the need to demonstrate the analytical performance of Companion Diagnostic (CDx) tests for patients and healthcare providers. We create internal standards for targeted NGS assays that reduce uncertainty and give clinicians and patients the accuracy in data to make confident medical decisions by eliminating false positive and false negative results, allowing the true underlying biology to be seen.

AccuGenomics has developed and commercialized technology solutions that enable test developers and implementers to demonstrate the highest performance levels of their sequencing assays. SNAQTM-SEQ (Standardized Nucleic Acid Quantification for Sequencing) enables a host of highly sensitive NGS applications that improve variant detection in liquid biopsy, SARS-CoV-2 pathogen screening, and rapid adventitious agent detection in cell therapy manufacturing.

Nick, can you elaborate more on the solutions and services provided by AccuGenomics.

We design and manufacture internal spike in standards that enable accurate detection of low abundance biomarkers from liquid biopsy or other sample types (can be any target, any platform and any sample type). We improve the true limit of detection (LOD) for NGS assays so even rare variants can be identified so that the molecular markers of cancer can be detected earlier, even from liquid biopsy samples. These internal standards provide improvements across a number of aspects with NGS testing:

Please go through the interview highlights: Ÿ

Please brief our audience about your company, its USPs, and how it is currently positioned as a reliable firm in the healthcare sector.

improve accuracy and enables the measurement of true LOD, which leads to better patient outcomes

Ÿ

AccuGenomics's mission is to improve the accuracy and performance of clinical sequencing testing for better patient outcomes. The rapid pace of innovation in NGS diagnostics continues to push the limits of detection for low abundance

are designed to be biochemically identical to the variant/target of interest; internal standards eliminate false positives and false negatives which improves the accuracy of all targeted NGS assay panels

Ÿ

are spiked into each sample at known concentrations during sample extraction, and co-process and co-vary

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Nick Lazaridis Ph.D., President AccuGenomics, Inc.

AccuGenomics is actively developing technology solutions that enable test developers and implementers to demonstrate the highest performance levels of their sequencing assays.

Ÿ

with the target of interest, providing a perfect QC workflow

Ÿ

provides gold-standard reporting to pathologists as copies of variant/ml of plasma

We're a disruptive precision diagnostics technology company that makes tools (assay specific custom internal standards) that precisely quantify biology to power molecular diagnostic tests to be more accurate, standardized and harmonized, even across platforms and decentralized testing sites. The ability to improve sensitivity without a loss of specificity is critical in NGS testing and diagnosis, and these improvements are required to correctly call additional true positives with low abundance (these can be incorrectly called as false negatives if using pre-defined

threshold algorithms provided from Dx test makers). The use of internal synthetic standards that biochemically mimic the variant of interest can provide a direct orthogonal measurement to determine a target-specific LOD for each sample, effectively tuning the detection limit to each sample.

With our collaborators, we have demonstrated an increase of 3-5-fold better sensitivity with targeted NGS panels, along with the elimination of false positives and false negatives that would otherwise lead to inaccurate variant calls and patient treatments. Use of internal spike in standards has a differentiated positive impact on precision medicine programs, and some of our pharma partners are finding strong value of the technology for transcript abundance measurements.

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We partner with labs that run NGS tests and make their tests more accurate and clinically relevant. Our business model is simple; design and manufacture client specified internal spike in standards that improve targeted NGS tests, and provide them at scale and at a price point that enables adoption across applications.

Being an experienced leader, share your opinion on how the adoption of modern technologies and platforms has impacted the diagnostics space and how is your company riding the technology wave?

The SARS-CoV-2 pandemic has widely opened the market to address the unique needs of our clients when it comes to sequencing testing. We have been able to develop multiple internal standards for all currently identified SARS-CoV-2 variants for multiple sequencing methods and platforms, and have advanced this evolving landscape of SARS-CoV-2 NGS testing in parallel to adoption of our technology with our clients focused on oncology clinical tests.

What would be your advice to budding entrepreneurs who aspire to venture into the healthcare space?

Self-belief and hard work are always good formulas for success. Surround themselves with other entrepreneurs that can provide great coaching to venture out their ideas in the health care space. Be flexible with their venture and adapt to market unmet needs, identify and execute a strategy that addresses those needs.

technology to clinical sequencing testing. A focus on our client's precision medicine unmet needs on sequencing methods to detect minimum residual disease (MRD) will give us the opportunity to become the leaders in quantitative sequencing testing. These new opportunities will help us add headcount to address our internal needs in designing and manufacturing standards, and also enable adding additional support for sales and marketing.

Please give us a few testimonials of your clients/customers and a list of awards/recognitions that accurately highlight your organization's position in the market.

Most of our clients operate under CDA so we cannot report their results. We can say that there is a lot of excitement when we show them how many false positives and false negatives we eliminate from their NGS methods. In addition to our announced grants from the USAF and NIIMBL, we've also participated in the FDASEQC consortium and at the NC Bioneer venture challenge. Of commercial importance, we are actively working with numerous clients that include pharmaceutical, CRO, diagnostic test manufacturers, and some of the leading academic institutions.

How do you envision scaling your organization's operations and offerings in 2022 and beyond?

Leveraging our grant awards from USAir Force and NIIMBL will bring new opportunities to adapt our

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10 Best Diagnos c Solu on Providers in 2023

CancerCenter.AI Transitioning Healthcare from a Quagmire to the Future Sustainable

A

rtificial Intelligence (AI) holds strong reasoning power and independent learning proficiency which can stimulate and enhance the critical thinking ability of a human brain. These fundamentals expand its reach to all the industries—the healthcare industry being no exception.

AI excels in recognizing complex patterns in large data volumes, extracting the relationships of complex features in the records, and identifying characteristics in the statistics that the human brain cannot perceive.

Looking at the recent developments, AI is already extracting promising results in radiology and oncology. The clinicians use programmed machines to process images rapidly, thus assisting them in focusing their time on the crucial fundamentals—for which their technical expertise is essential.

Integration of AI technology in the treatment of severe diseases like Cancer improves the accuracy of diagnosis and facilitates clinical decision-making, leading to better health outcomes. AI guided clinical care plays a comprehensive role in lessening health inconsistencies, especially in treating severe diseases.

Clinical applications of AI and Machine Learning (ML) in cancer diagnosis and treatment are the future of medical guidance towards faster mapping of a new treatment for every individual.

In other words, using advanced machine learning techniques in medical image diagnosis on a regular basis is the next big leap that our society needs to transform itself towards new horizons. Certainly, CancerCenter.AI facilitates this transformation.

Under the leadership of Piotr Krajewski, CEO and Cofounder, CancerCenter.AI's state-of-the-art technology substantially improves human health conditions.

In an interview with Insights Care, Piotr Krajewski highlights the contribution of CanerCenter.AI in connecting biology with Artificial Intelligence. He explains how AIbased assistance helps oncologists with precise treatments.

What are the core aspects of CanerCenter.AI, and what is its vision and mission in the healthcare niche?

In cancer diagnosis and therapy, medical image processing and analysis need the combined opinion of many experts.

The exponential growth of AI in the last decade is evidenced to be a potential platform for optimal decision making by super-intelligence—AI-based algorithms hold great promise to pave the way to comprehend the unusual genetic mutations and aberrant protein interactions in the initial stage.

AI-based assistance to pathologists and physicians could be a great leap forward toward the prediction of risk, diagnosis, prognosis and treatments of life-threatening diseases.

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Piotr Krajewski CEO and Co-founder CancerCenter.AI

Our aim is to make high-quality cancer diagnosis available anywhere in the world, regardless of whether you live in a rich or poor country.

To clarify, pathologists, radiologists, geneticists and oncologists work together to find the best solutions.

Firstly, the amount of data is huge. Furthermore, the overall decision process takes a lot of time. However, there is a cure for this disorder. Secure and compliant cloud platforms

with algorithms based on collecting big data solve the problem. Both tools enable patients and doctors to share images. Most of all, they provide an automated, accurate pre-diagnosis.

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What are the challenges in providing cancer treatment and comprehending these adversities, how does CancerCenter.AI thrive towards transforming this scenario?

The current diagnostic workflow around the world is as follows: First, a digital scan is taken, usually using MRI or CT scanners. Next, a radiologist examines the scan looking for signs of a tumor. If the result looks positive, a biopsy is taken, and a Pathologist examines the sample under a microscope. If that examination is positive, then a panel of doctors makes a decision on the type of treatment. The diagnostic workflow may be repeated multiple times during a treatment to assess the treatment outcome.

The main challenge in this area is that the diagnostic process is too long!

The first reason is that currently there are not enough pathologists to handle this workload; it is a manual process; many departments use microscopes without digital slides and send slides by post, in particular when a second opinion is required. Many pathologists do not use standardized reports. There are mistakes, and the process is very slow and expensive.

There is a major shortage of radiologists and pathologists from a doctor's perspective. About five times more are needed to cope with the current demand around the world.

Also, the process relies on an inefficient disjointed set of legacy technologies.

From data scientists and innovators' perspective, it's hard to obtain up to date, high-quality datasets needed to train and improve algorithms. An ideal solution would be a diagnostic process that is fast, cheap and more accurate.

Our vision is to foster an ecosystem of apps and algorithms connected by APIs, of which we aim to be the gatekeepers.

Data will be owned by the patient and available to doctors in accordance with GDPR and other medical Information Governance regulations. Our aim is to make high-quality cancer diagnosis available anywhere in the world, regardless of whether you live in a rich or poor country.

We support Oncology Diagnosis (pathology and radiology) in better and faster diagnosis using AI, Deep Learning (DL) and Machine Learning (ML). Using AI and Deep Learning in Cancer Diagnosis makes the whole treatment much more efficient. Specialized algorithmic solutions analyze medical images for pathology and radiology.

What solutions does CancerCenter.AI offer, and how do these offerings significantly impact the healthcare industry?

We would like to help pathologists, radiologists and oncologists with a better and faster cancer diagnosis. For that, we use Deep Learning (AI) and Software Tools. In the second half of the year, we are going to offer a Medical Second Opinion platform in oncology for patients also. We have developed specialized algorithmic solutions to analyze medical images for Pathology and radiology with faster and better than human accuracy.

Our solutions, which are both in API and Web Platforms, are designed to offer faster and better access for second and third diagnostic opinions by medical professionals to help develop a therapeutic approach quickly. This will help the patients and physicians by reducing anxiety caused by not knowing what they are dealing with.

Our answer to these challenges is a tool for digitalization PathoCam and a cloud platform - PathoPlatform that will enable oncologists/pathologists and in the future—patients to share their cases to provide cancer diagnosis supported

by AI. Once the system is in place, the process will be five times more efficient than it is today. Both doctors and patients will have access to a pool of experts to gain a second opinion to validate the diagnosis.

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the decision-making process needs the combined opinion of pathologists, radiologists, geneticists and oncologists.

In addition, the amount of data is huge and the overall decision process to make the final conclusion takes a lot of time. Likewise, the shortage of experienced oncologists is a worldwide problem. The same is with radiologists, pathologists and geneticists. Being engineers and entrepreneurs, we decided to do something about it.

Being an experienced leader, share your opinion on how the adoption of modern technologies and platforms has impacted the diagnostics space and how is your company riding the technology wave?

When we started this project, it was not easy to find oncologists who would like to apply AI in their job. Now it is much better.

During COVID, many oncologists had to work remotely, and they saw the value of this kind of product. Additionally, we help them to decrease the risk of bad diagnosis.

What would be your advice to budding entrepreneurs who aspire to venture into the healthcare space?

Our solutions do all the work—segment images, find regions of interest, generate statistical descriptions of images, count cells, mitosis, and even recognize the type of cell.

We provide doctors with all the necessary tools to work with medical images. To clarify, we connect the new technology of medical imaging and the most advanced and futuristic solutions from the field of mathematics and computer science (machine and deep learning). Cancer Center applies deep learning techniques to the field of oncology/radiology.

A huge training set of medical images along with categorization technology allow computers to predict multiple diseases with better-than-human accuracy.

The Healthcare sector is not easy if we talk about a fast sales process and generating income. It would be best to have more time and money while venturing into the healthcare industry. Building relations and trust take time.

But if you know that product could help to save lives - that is a huge motivation!

How do you envision scaling CancerCenter.AI's operations in 2022 and beyond?

We would like to scale our sales through existing partners/distributors/producers in oncology. We are looking for partners in every country. At the same time, we are looking for an investor who will help us to scale our organization's reach to greater heights.

Piotr, enlighten our readers about the inspiration behind the establishment of CancerCenter.AI. Jakob is our true inspiration. He was lucky to win his battle with cancer. Because of him, we have learned firsthand how inefficient and slow the process of cancer diagnosis is. This is to say; in cancer diagnosis and therapy,

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https://cancercenter.ai

Fmtal Aes

Diagnti

are Aided by

Dital

Technologies "Health is the Motive; Digital is the Instrument"

T

echnology has undoubtedly been a boon during the global crisis caused by the pandemic. The coronavirus accelerated the adoption of digital technology, transforming the healthcare industry. Industry players were eager to adopt technological solutions to maintain a competitive edge and survive the challenging times. The diagnostics area explicitly was sufficiently instant to go through computerized change and is arising to be a critical part of the medical services industry.

The diagnostic process involves a wide range of technologies and tools, but health information technology (health IT) tools are the primary focus of this chapter.

Electronic health records (EHRs), clinical decision support,

patient engagement tools, computerized provider order entry, laboratory and medical imaging information systems, health information exchanges, and medical devices are all included in the comprehensive health information technology (HIT) category.

Let's have a look at them and learn more about them!

Wearable Technologies mHealth applications and wearable technologies are reshaping how patients and medical professionals receive healthcare, and they may also impact the diagnostic procedure. Patients and clinicians alike now have access to a wide range of mHealth applications thanks to the recent explosion in mHealth applications. Drug reference guides,

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medical calculators, clinical practice guidelines, textbooks, literature search portals, and other decision support tools are among the many mHealth applications designed to aid clinicians at the point of care.

Although the researchers who carried out the study noted that the evidence was limited, a systematic review revealed an increase in the appropriateness of diagnostic and treatment decisions when mobile devices were utilized for clinical decision support; as a result, additional research will be required to reliably conclude whether and how these mobile devices to aid, when and how they should be used.

indicated pulmonary embolism are an example of the former.

Common platforms for measuring diagnostic errors will enable comparisons of diagnostic error rates across organizations and settings for health IT systems utilized by multiple healthcare organizations or across various locations (inpatient and outpatient). This committee has made an important recommendation to improve the identification of diagnostic errors. Health IT vendors should make it easier for organizations to figure out the rates of diagnostic errors, especially those that are common and have severe consequences for patients, by developing tools.

Usage and Human Factors Flow of Information Without usable, functional health IT systems, it is impossible to realize the potential benefits of health IT for improving diagnosis. The term "usability" indicates the "Extent of a product to be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use."

The human-centered design approach seeks to balance the requirements of the computer and software technical systems and those of the larger sociotechnical systems.

Some health IT vendors have implemented human-centered design principles, but this is not a widespread practice.

Additionally, usability issues may not become apparent until the system has been implemented or used extensively.

As a result, it is critical to enhance health IT design, implementation, and use continuously.

Communication Breakdowns constitute a significant cause of adverse events, including diagnostic errors, and the timely and efficient exchange of information between healthcare professionals and patients is essential to improving diagnosis.

Health IT has the potential to cut down on breakdowns in intra- and interpersonal communication, as well as in communication between patients and health care professionals and the exchange of information (such as the reporting of test results). Health IT can also help with the tracking of test results and follow-up. EHRs, for instance, can help with care coordination if they "automatically track referrals and consultations as well as ensure that the referring physician is easily able to follow the patient's progress/activity throughout the continuum of care," according to the American Medical Association (2014).

Clinical Workflow To close, Utilizing the vast amounts of patient data in health IT databases, health IT can also be used to measure diagnostic errors. For instance, it is possible to develop algorithms that periodically scan electronic health records (EHRs) for diagnostic errors or clinical scenarios that might indicate that a diagnostic error has occurred. Patients with newly diagnosed pulmonary embolism who were seen by a clinician in an outpatient or emergency department two weeks before diagnosis with symptoms that may have

The remarkable ascent in utilizing innovation is vital to the well-being area's endeavors to develop different client experiences and back clinical choices. It has turned into a spine for proceeding with development. Digital diagnostics will require an industry-wide effort from stakeholders to translate innovation into impact, validation of these tools, and a new regulatory approach to gain traction and acceptance.

- Shreyasi Shelke

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10 Best Diagnos c Solu on Providers in 2023

Providing a 'Breakthrough' Technology to help Transform Cancer Care

C

ancer is an ailment that affects the social fabric of millions of families, as it seems to have reached epidemic proportions over recent years.

Understandably, the 'C'-word causes more fear and anxiety than most other ailments today, often dampening spirits and dashing hope. It is a disease that has dominated much of the healthcare efforts of the 21st century.

On the brighter side, medical solutions providers are fighting tooth and nail, driving a positive change, to counter this serious challenge and overcome its adversities. One of the key challenges in the fight against cancer is improving the ability to detect cancer at its earliest stages when patients have the best chance for survival. There is an immediate need for diagnosing and detecting the malignancy when it is more treatable, and outcomes are better.

Recognizing this very need for early detection Imagion Biosystems Ltd is attempting to become a leading player in the healthcare space. With a multidisciplinary team and a mission to make cancer more detectable, the company is implementing advanced technology to detect cancer with better specificity and sensitivity than conventional imaging technologies.

Under the proficient leadership of Robert Proulx, CEO, Imagion Biosystems combine molecular targeting with nanotechnology and enables advancements in image analysis through machine learning and AI—the company aims to detect cancer at its earliest stages non-invasively without using radiation.

In the following interview with Insights Care, Robert Proulx sheds light on the company's journey showcasing the current industry scenario, and his opinions on the company's future.

Below are the interview highlights: Please brief our audience about Imagion Biosystems, its USPs, and how it is currently positioned as a reliable firm in the healthcare sector.

Imagion Biosystems is developing improved diagnostic imaging and therapeutic products based on our proprietary magnetic nanoparticles. Our nanoparticle technology uses biosafe materials to non-invasively detect or treat diseased tissues, like cancer, while avoiding the use of radiation or radiotracers. By focusing on the use of magnetic nanoparticles we believe we can deliver improved diagnostic imaging methods that work within existing clinical care workflow and are better for the patient.

Shed some light on your offerings and how they impact the industry and your clients.

Today, globally, we spend over $100B annually to diagnose cancers, but we still don't catch them early often enough.

Imaging technologies provide good anatomical images but are not capable of differentiating benign from malignant lesions and often require the use of radioactivity.

Certain cancers like pancreatic or ovarian cancer are too often detected way too late because they are asymptomatic, and current imaging methods are not well suited for identifying these tumors. In other cases, like prostate cancer, we have screening tools but with high false negative and false positive readings resulting in missed diagnoses and unnecessary biopsies.

Our first diagnostic imaging product aims to improve the ability to identify metastatic breast cancer by noninvasively detecting if the tumor has spread to the lymph nodes. Today the standard of care for nodal staging is a biopsy procedure, with approximately half of all patients having a negative test, meaning they had to have a biopsy to find out nothing was there.

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“

Our goal would be to have multiple imaging products in our pipeline advancing into clinical studies and have the organizational infrastructure to support larger studies and early commercial production.

Bob Proulx CEO Imagion Biosystems

“

About the Leader CEO Bob Proulx has more than 30 years of experience in the development and commercializa on of novel life science tools and medical device/diagnos c products. Having joined the company in 2015, Bob led the restructuring and refinancing of the company to create Imagion Biosystems and undertake an IPO on the Australian Securi es Exchange. Under his leadership, the company is now a clinical-stage company with mul ple products in the R&D pipeline.

Exemplary Exper se: I think the fact that the FDA designated our MagSense® HER2 Breast Cancer product as a Breakthrough Device speaks volumes. The Breakthrough Device program is reserved for those medical device technologies that are considered to "provide for more effec ve treatment or diagnosis of life-threatening or irreversibly debilita ng human disease or condi ons" and either address an unmet need or offer a significant advantage over exis ng products.

The recogni on by the FDA of the poten al for our MagSense® technology in breast cancer care is very gra fying. Another example comes from the MD Anderson Cancer Center, the world's leading cancer research and treatment ins tu on. Early on, we established a scien fic collabora on with the Department of Imaging Physics at MD Anderson, and along the way, the ins tu on converted a por on of our sponsored research funding into shares in the company. They have con nued to hold those shares, and we consider having them as a shareholder a privilege.

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Using our MagSense® targeted nanoparticles could reduce the need for biopsy procedures and save many patients from having to have lymph nodal biopsies and the concomitant pain and morbidity associated with nodal lymph surgeries.

This product has been designated by the U.S.FDA as a breakthrough device because of its potential to change patient care in the nodal staging of breast cancer.

Being an experienced leader, share your opinion on how the adoption of modern technologies and platforms has impacted the diagnostics space and how is your company riding the technology wave?

Firstly, we should recognize that the healthcare industry is generally conservative in its adoption of new technologies.

Healthcare practitioners and payers are cautious about changing existing practices and standards of care, so any new technology will take time to be adopted. But recent advances in two areas may be of interest to Imagion's efforts.

We think the recent advances in blood-based testing for circulating tumor cells and nucleic acids bode well for earlier detection of patients who may be developing cancer.

Early warning signs in the blood would be a good indication that an Imagion imaging test could help identify if the specific cancer of concern is present.

Combined with advances being made in image analysis through machine learning and AI, we hope that we can make cancer detectable at its earliest stages when they are more treatable, and outcomes are better.

What would be your advice to budding entrepreneurs who aspire to venture into the healthcare space?

sectors, the regulatory oversight in the medical industry is pervasive.

Additionally, better technology, by itself, may never make it to the market, so you really must do your homework.

Identifying unmet medical needs and then identifying how you are going to solve that problem in a commercially scalable and market-acceptable way is key, and you must be in it for the long haul.

How do you envision scaling your organization's operations and offerings in 2022 and beyond?

We are anticipating growing the organization to prepare for the next phase of development. At the beginning of 2022, we moved into a new facility that gave us expanded R&D capabilities and increased nanoparticle manufacturing capacity. Our goal would be to have multiple imaging products in our pipeline advancing into clinical studies and have the organizational infrastructure to support larger studies and early commercial production.

It is a very gratifying area to work in. It is very motivating and rewarding to know that what you are working on could impact patients' lives. But it is also a hard industry to work in and is heavily regulated. Unlike FinTech or other tech

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