Infectious Diseases

A Mediaplanet Guide to Innovations in Disease Mitigation and Treatment

Infectious Diseases This publication sheds light on infectious diseases, from careers in fighting pandemics like COVID-19 to innovations in hepatitis treatment

Learn about career options in the labs that directly influence the outcome of the COVID-19 pandemic and other infectious threats in the future

JUNE 2021 | FUTUREOFPERSONALHEALTH.COM

Protecting healthcare workers is still as important as ever, and there may be a smarter way to do so using a respirator fit tester

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ascp.org The mission of the American Society for Clinical Pathology is to provide excellence in education, certification, and advocacy on behalf of patients, pathologists and laboratory professionals.

Find out more about ASCP and careers in medical laboratory science on pages 4–6

Why Viral Hepatitis Elimination Efforts Need Immediate Support International donors can’t wait to join the fight to eliminate hepatitis. Without their support, low- and middle-income countries face the burden of expensive treatment for liver cancer.

Viral hepatitis is one of the most neglected global health crises of our time. Globally, it is the leading cause of liver cancer, and it claims over a million lives every year. However, we do have a vaccine and effective treatments against hepatitis B, as well as a cure for hepatitis C. These tools, combined with prevention and testing strategies, mean we have the opportunity to eliminate viral hepatitis as a global public health threat, which will save millions of lives.

For too long, hepatitis elimination efforts have been

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under-funded, not prioritised, and poorly resourced.

The COVID-19 pandemic has set the world back even further from achieving the elimination of viral hepatitis by 2030, which was a target set by the World Health Organization in 2016.

A pressing need With a person dying every 30 seconds from a hepatitis-related illness, we can’t wait to act on viral hepatitis — even while we are in the current COVID-19 crisis. The 290 million people who are unaware that they are living with viral hepatitis can’t wait for testing.

People living with hepatitis can’t wait for life-saving treatments. Expectant mothers can’t wait for hepatitis screening and treatment.

Newborn babies can’t wait for

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Cary James CEO, World Hepatitis Alliance

the hepatitis B birth-dose vaccination. And people affected by hepatitis can’t wait to end the associated stigma and discrimination.

Viral hepatitis affects every country in the world. It disproportionately impacts the lives of those most underserved by health systems, including refugee communities, migrant communities, indigenous populations, LGBTQ communities, drug-users, and incarcerated people.

Lack of access There is no global funding for viral hepatitis like there is for HIV, tuberculosis, and malaria, so the world’s poorest countries and communities are being left alone to tackle this crisis. Beyond the financial costs are the human costs of lives being continually lost to a preventable disease.

The lack of access to treatments for hepatitis is not unique to low-and-middleincome countries. Around the world, people know that they are living with a deadly disease, but the existing treatments remain unavailable to them.

Babies are born every day with hepatitis B, unknowingly passed on to them by their mothers at birth. However, the hepatitis B birth-dose vaccine is available for less than one dollar. Only 23 percent of coun-

tries in Africa give the hepatitis B birth-dose vaccine. Without the vaccine, these children are born with a life-limiting illness that could have been prevented. Additionally, mothers are left with the burden of guilt after unknowingly passing on hepatitis B to their child.

This year, the World Hepatitis Alliance — a global network of over 300-member organizations in 100 countries — is launching the global “Hepatitis Can’t Wait” campaign for World Hepatitis Day, celebrated on July 28 every year. The day is crucial to show policy makers and the global community that hepatitis elimination is essential, and that there are people around the world who will hold them accountable to their commitment of eliminating hepatitis by 2030. n

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Publisher Shannon Ruggiero Managing Director Luciana Olson Lead Designer Tiffany Pryor Designer Keziah Makoundou Lead Editor Mina Fanous Copy Editor Lauren Hogan Partnership and Distribution Manager Jordan Hernandez Director of Product Faye Godfrey All photos are credited to Getty Images unless otherwise specified. This section was created by Mediaplanet and did not involve USA Today.

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The Foundation That Will Help Pay for Your Hep C and Infectious Disease Copays

The HealthWell Foundation® has provided over $2.1 billion in grant support to underinsured patients who need, but can’t afford, lifechanging medical treatments.

They’ve helped over 615,000 patients across over 80 disease areas, including 24,000 patients living with hepatitis C. “Our mission is to make sure that no patient in this country has to choose between affording their prescribed medications and paying for food or rent or daily necessities,” says Alan Klein, chief development officer at HealthWell.

Klein explains the program: What is foundation assistance?

Qualified patients can receive a 12-month grant of up to $30,000 from HealthWell.

If you take the standard of care hepatitis C medication treatment regimen, the vast majority of patients achieve

a curative state within about three months.

We’ve been able to help people afford medication, which not only cured their hepatitis C, but possibly prevented them from a worse outcome than a hepatitis C diagnosis.

What are patients saying about your copay assistance program?

A HealthWell Foundation Hepatitis C Fund grant recipient, Len. S., from Omaha, said: “Twelve weeks later, labs showed no HCV detected. I was released from treatment because I was cured. The 12-week treatment cost would have been over $70,000. For a fixed-income person and a retired educator, it was absolutely prohibitive. The staff at the specialist’s office intervened with my insurance plan — it would have brought the cost down to around $12,000. That was still a very difficult thing for us. Along came HealthWell,

What is the grant application process? How long does it take to get approved?

Alan Klein Chief Development Officer, HealthWell Foundation working with the pharmacy, and a grant from them reduced my copay to $0! I gratefully and sincerely consider the Foundation part of my lifesaving cure. I will be forever grateful to them.”

What other conditions do your grants cover?

Our biggest funds, other than hepatitis C are multiple myeloma, multiple sclerosis, pulmonary fibrosis, and cystic fibrosis. We have offered assistance in approximately 80 disease areas. Visit our Disease Funds page for a list of the diseases we currently cover.

Please apply. It takes under eight minutes. You have to be able to answer “yes” to three basic questions. Do you have health insurance of any kind?

Do you have a prescription for an FDA-approved or compendia listed medication for one of the disease areas that we cover? Do you meet the income threshold (generally 500 percent of the federal poverty level)? We are then able to instantly enroll you into that specific fund to pay your medication copay or insurance premiums.

How did COVID affect the program?

HealthWell opened three COVID-19 funds, including a fund to help patients afford food and medication delivery, so they could comply with stay-at-home orders and social distancing.

We also helped people who had been laid off or furloughed during COVID keep their health insurance by fully reimbursing them for the employee portion of COBRA insurance. This initiative was also recently included as part of a larger package signed into law. The government will now pay the COBRA for those similarly affected people under the American Rescue Plan Act of 2021 (ARPA).

The third one is for frontline health care workers. We’re concerned about the same syndrome seen for 9/11 first responders, where about six months after the crisis was over, a significant number of those heroes developed post-traumatic stress disorder (PTSD) from Ground Zero deaths.

Grants will pay for copays associated with behavioral health medication, psychotherapy, or talk therapy, as well as subsequent transportation costs.

What’s next for the HealthWell Foundation®?

We recently launched an updated version of our disease fund tracking tool, Real-Time Fund Alerts. Anyone who registers can receive instant email notifications to track the status of HealthWell’s diverse portfolio of disease funds in real-time. n Kristen Castillo

To learn more about the HealthWell Foundation and the disease areas we cover, visit www.healthwellfoundation. org/disease-funds/

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ing to pursue a Ph.D. or M.D. Those salaries start at $150,000.

The Lab Profession You Need to Join The medical laboratory workforce is an in-demand career these days.

There is a shortage of laboratory professionals as many are retiring while demand for laboratory testing is increasing.

“The COVID pandemic put a spotlight on how important the laboratory staff is,” says Kimberly W. Sanford, M.D., MASCP, MT(ASCP), board president of the American Society for Clinical Pathology (ASCP), the world’s largest professional membership organization for pathologists and laboratory professionals. “We all saw the days and weeks of backlogs of test results, where laboratories were just inundated with testing.” Laboratory professionals were critical in performing those tests and determining diagnoses.

Dr. Sanford adds that in addition to COVID-19 testing, lab

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professionals perform highly complex and precise tests daily as part of patient care.

Diagnostic detective Careers in laboratory science are dynamic and different every day. It’s a rewarding, hands-on profession for people who love science.

“You’ll never be bored pursuing a career in laboratory medicine,” says E. Blair Holladay, Ph.D., MASCP, SCT(ASCP) CM .

“We are scientific detectives, searching for the clues and finding the answers to an issue or ailment a patient is experiencing.” Those answers, he continues, are the diagnoses that often help save lives. And more laboratory professionals are needed in the field.

Phlebotomists are in high demand with a job outlook rate of 17 percent between 2019 and 2029. The job rate for medical laboratory scientist (MLS) and medical laboratory technician

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(MLT) is expected to be 7 percent between 2019 and 2029.

Average growth rate for all occupations is 4 percent.

Opportunities Lab professionals provide their clinician colleagues with the information needed to make informed decisions about a patient’s treatment. Without that laboratory input, diagnosis and treatment would be a guessing game at best.

“The laboratory staff is a critical part of the healthcare team and if you do not have trained, educated, certified laboratory professionals and pathologists, you are not going to be able to provide the analysis, and therefore the diagnosis, for your patient in order to render treatment,” says Dr. Sanford.

To help students get started on their lab science career journey, ASCP launched whatsmynext.org.

The site explains the education and experience requirements needed to pursue different careers in the laboratory. For example, with a high school diploma and completion of an educational program, one can become a phlebotomist or a medical laboratory assistant.

One can become a medical laboratory technician (MLT) or a histotechnician (HT) with an Associate’s degree and completion of a program. If you have a bachelor’s degree and complete a program for medical laboratory scientist (MLS) or cytotechnologist (CT), one can become an MLS or CT. “Over 95 percent of MLS students nationwide have jobs after they graduate,” says Dr. Sanford.

Careers in lab science are fairly well compensated, with MLTs earning $30,000 to $50,000 a year and MLSs earning $60,000 to $100,000. There are career advancement opportunities too, with many choos-

Diversity, equity, and inclusion ASCP created a diversity, equity, and inclusion committee and grassroots volunteer network to do targeted outreach to underrepresented communities and help educate students and young adults on the different opportunities in the field. They’re committed to helping Native Americans, Latinos, and Black people, who are the most underrepresented among clinical laboratory personnel relative to the general population and the overall workforce, understand and pursue opportunities to enter and grow in the field.

“Our profession needs to reflect the populations that we serve,” says Dr. Holladay. “And as members of the laboratory, there is not a single population we don’t serve.”

Laboratory leaders Dr. Holladay is excited for the next generation of laboratory leaders. They are the future of the profession and hold the keys to the research and scientific discovery that will push medicine forward.

“Here’s an opportunity for you to be on the front line, making diagnostic decisions, where you’re really bringing a wealth of solutions to save patients’ lives every single day,” he says. n Kristen Castillo

To get started researching your career in lab sciences visit www.whatsmynext.org.

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Why You Should Consider a Career in the Medical Laboratory Workforce Below are some examples of the exciting opportunities available in laboratory science and what makes them a good career fit:

Phlebotomist

As a PBT, you will perform blood draws and clerical tasks, process samples, and provide support for clinical testing.

Medical Laboratory Technician

MLTs collect and process patients’ specimens to prepare them for a range of routine tests that include blood banking, chemistry, hematology, immunology, microbiology, molecular biology, and urinalysis.

Medical Laboratory Scientist

As an MLS, you’ll perform routine and complex tests to provide information necessary for the diagnosis and treatment of disease. You will troubleshoot issues with specimens, testing, and instrumentation.

Pathologist

Pathologists lead teams of laboratory professionals to provide definitive diagnoses. Clinical pathologists develop and validate tests, interpret laboratory test results, and consult with members of the clinical care team to determine diagnoses. Anatomic pathologists examine tissues, cells, and organs for effects of disease. Both anatomic and clinical pathologists are medical doctors who collaborate with professionals across the healthcare spectrum.

Why become a laboratory professional?

• If you have an interest in science and/or technology, and an inquisitive

mind that likes to solve problems and puzzles, there are a range of medical laboratory careers that could suit you.

• Medical laboratory professionals require as little as a high-school diploma

and on-the-job training to start their career in medical laboratory science.

More than 95 percent of MLS students have employment after they graduate, and other professions in the lab boast similar statistics.

• There

are myriad career advancement opportunities, with undergrad laboratory professionals earning anywhere from $30,000-$100,000 a year, and Ph.D. and M.D. graduates earning starting salaries of $150,000.

Get started in your career as a laboratory professional today by visiting whatsmynext.org and researching the many exciting opportunities available.

WWW.ASCP.ORG

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Could Becoming a Microbiology Technologist Be Your Next Move?

If you’ve always dreamed of using a microscope to study fungi, viruses, bacteria, and other organisms that are invisible to the naked eye, there may be no better time to explore the career field known as microbiology.

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f you become a microbiologist, your work may even help promote an understanding of the novel coronavirus. If microbiology is your area of interest, rest assured that you have career options to explore.

For example, those who have completed a bachelor’s degree in a qualifying field such as chemistry or biological

science, or have a baccalaureate degree with additional training in the aforementioned fields, can get certified as a technologist in microbiology through the American Society for Clinical Pathology (ASCP) and the American Society of Microbiology (ASM).

Individuals who earn the certification come away with a knowledge

of how to work as a team with other lab professionals. They also learn how to practice clinical microbiology onsite, and they develop skills in creative and clinical thinking, as well as customer service.

ASM has several inspiring stories from real people working in microbiology today, as well as potential areas

technologists may help make headway in understanding important issues that affect humanity. Those areas of study include climate change, the circadian rhythms of bacteria, and infections like yellow fever and HIV, and, of course, the novel coronavirus. n Melinda Carter

CLINICAL MICROBIOLOGY CERTIFICATION self-paced & online • 4 courses under $4,000 • participating labs in 30+ states

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The Plan to Prevent, Treat, and Eliminate Hepatitis B and Hepatitis D More than 257 million people worldwide suffer from chronic hepatitis B, an inflammation of the liver that’s caused by infection of the hepatitis B virus.

Hepatitis B, the most common liver infection in the world, is caused by the hepatitis B virus (HBV). It’s transmitted through direct contact with infected bodily fluids, including blood and semen, or during pregnancy.

People with chronic HBV infection can develop serious liver damage or liver cancer, which can cause premature death. Every year, almost 1 million people die from this chronic

infectious disease, which is more than deaths from hepatitis C, HIV/AIDS, or malaria.

Diagnosis, treatment, and prevention The condition is diagnosed by a blood test. Chronic hepatitis B may be treated with pegylated interferon alpha, or with pills called nucleoside or nucleotide analogues.

The best way to prevent hepatitis B is to get vaccinated. Over a billion doses of the hepatitis B vaccine have been administered in the past 40 years. The vaccine has been shown to be effective in approximately 95 percent of cases.

Hepatitis D Globally, HDV affects nearly 5 to 10 percent of people who have chronic hepatitis B virus infection. This co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression towards liver-related death and hepatocellular carcinoma. There is currently no approved treatment that can cure HDV co-infection.

The vaccine against hepatitis B is important, too, because it is the only way to prevent hepatitis D (HDV infection), which needs HBV for its replication.

Mongolia, the Republic of Moldova, and countries in Western and Middle Africa are considered HDV hot spots. In

Mongolia, 15 percent of all of the country’s deaths are caused by hepatitis.

Public health goals The sustained efforts to vaccinate everyone globally against hepatitis B, which also prevents hepatitis D, are promising.

A World Health Organization (WHO) study estimates that with hepatitis B vaccination, diagnostic tests, medicines, and education campaigns, 4.5 million premature deaths could be prevented in low- and middle-income countries by 2030. WHO’s global hepatitis strategy, which is endorsed by all WHO Member States, aims to reduce new hepatitis infections by 90 percent, deaths by 65 percent, and increase treatment to 80 percent between 2016 and 2030.

The success of this strategy will depend not only on these vaccination efforts, but improving the diagnosis and treatment of chronic HBV and HDV with existing therapies, as well as new therapies able to cure existing HBV and HDV infection. n Kristen Castillo

Replicor is developing the most effective therapy to cure HBV and HDV Curing HBV infection is prevented by suppression of immune function by the surface antigen protein (HBsAg).

Replicor’s NAP technology is the most effective way to completely eliminate HBsAg, allowing recovery of durable immune control of HBV. NAPs are safe and effective in removing HBV infection from the liver and achieving HBV cure, with up to 78% of patients no longer requiring therapy.

NAPs are safe and effective at all stages of HBV infection or liver disease, regardless of ethnic background, viral genotype or the presence of co-infection (i.e. hepatitis delta).

No other antiviral agent approved or in development has achieved this level of potency.

Once weekly self injection of NAPs with existing therapies will be effective with a finite course of treatment.

NAPs are protected worldwide with over 200 patents.

Replicor is working diligently to make the most advanced therapy for curing HBV and HDV available to patients as rapidly as possible.

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How One Nonprofit Is Tracking the COVID-19 Pandemic Throughout the pandemic, Covid Act Now has been working with experts across many industries, including the tech sector, to keep the public informed by providing timely and accurate data about COVID-19 in the United States.

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n the beginning of the pandemic, information was spotty. Covid Act Now is an independent nonprofit started by volunteers in March 2020 that helped streamline information from a variety of reputable local, state, and federal sources. They now have a dozen employees, as well as many volunteers.

“Partnerships with teams across policy, academia, and tech have been very helpful, because no individual group is in a position to reach the general public in an easily accessible way,” says Brett Boval, Covid Act Now’s lead product manager. “But together, we can

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give them relevant information that is actionable. We can give them not just the facts, but also help them understand them in context.”

Empowering consumers The nonprofit tracks COVID-19 and vaccination rates in every American state, including over 380 metros, 3,100 counties, and two United States territories.

Covid Act Now works with the Georgetown University Center for Global Health Science and Security, Stanford University Clinical Excellence Research Center, and Harvard

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Global Health Institute. Their partners include COVID Exit Strategy, the COVID County Data project from Valorum, COVID Explained, and others.

Their COVID-19 Community Vulnerability Index is by Surgo Ventures.

They get their data from a variety of official sources, including the Centers for Disease Control and Prevention, the U.S. Department of Health and Human Services, The New York Times, and official state and county dashboards.

According to Boval, there are disparities in vaccinations across the country. For example, at the time of

this writing, Vermont was well vaccinated, but Mississippi was not.

Boval said this trusted data has helped empower people to make informed decisions about their health and associated risks during the pandemic.

Currently the information is focused on both COVID-19 risk and vaccine tracking data. He said there are disparities in vaccinations across the country. Boval said the organization will continue until the federal government is able to take over all of the data reporting about COVID-19 cases and vaccine information. n Kristen Castillo

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Even with multiple SARS-CoV-2 vaccines now available, public health experts recognize the continuing need for rapid and reliable diagnostic testing.

Whether for triage, sports arenas, travel, or workplace testing programs, robust testing capabilities remain critical to opening society. Consequently, health authorities are dedicating significant resources to expand the available ecosystem of diagnostic testing.

The historical gold-standard tests for COVID-19 are polymerase chain reaction (PCR) molecular tests, which detect the genetic material of the virus.

The best performing (detect low levels of virus) tests can be processed by a central lab, with options also available at the Point-Of-Care (POC). These results vary in turn-around time, with central lab results often taking several days, or longer, when demand is high.

Rapid tests, in contrast, are typically antigen tests that look for viral proteins.

These POC tests provide results in 15-20 minutes, with less complex workflows than PCR. However, they are generally perceived as less accurate because they

typically require more virus to be present in the sample before they record a positive result — thus leading to more frequent false negatives, especially among people who don’t have symptoms.

Strong need exists for antigen POC platforms that mimic PCR performance, but with typical antigen cost and workflows.

Qorvo Biotechnologies is attempting to address this market gap.

This spring, the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADxSM) initiative, awarded a $24.4 million contract with funds from the Biological Advanced Research and Development Authority, or BARDA, to advance the production and market launch of the Qorvo Biotechnologies Omnia™ test platform and SARSCoV-2 antigen test. This recently received Emergency Use Authorization (EUA) from the Food and Drug Administration.

How does it work? Unlike traditional diagnostic approaches that rely on optical or fluorescence detection, the Qorvo Omnia system uses high-frequency Bulk Acoustic Wave (BAW) sensors — which are typically used in cellphones and Wi-Fi routers — to detect the presence of COVID-19 antigens from an

PHOTO: COURTESY OF QORVO

The Tech Poised to Usher in a New Era in Disease Detection anterior nasal swab. A small cartridge containing the BAW sensor is used to measure a reaction between the biochemical coating on the BAW sensor surface and the sample being tested. As mass is added to the surface, a change in frequency occurs that can be converted to a known concentration.

The BAW sensor’s extremely high frequency (it resonates at 3 GHz, or 3 billion cycles per second) enables a low limit of detection (LOD) and is 100 percent specific, critical in low prevalence settings to minimize false positives.

“This new approach to testing has the potential to transform disease detection,” said Fred S. Apple, Ph.D., a member of Qorvo Biotechnologies’ advisory board, co-medical director of the Toxicology Laboratory at Hennepin Healthcare and Hennepin County Medical Center and professor of Laboratory Medicine & Pathology at the University of Minnesota. “The Qorvo Omnia system is focused on producing results comparable to PCR testing with the ability to be deployed for a wide range of rapid Point-Of-Care diagnostic tests — including tests for the next deadly pathogen to cause an outbreak.”

With its combination of high sensitivity, specificity, and speed, BAW is well positioned to meet the ongoing need for rapid diagnostic testing in high-volume settings, helping American society return to normalcy. n Bryan Bothwell, Senior Director, Qorvo Biotechnologies, LLC

*This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.

To read more about this article/product visit www.qorvobiotech.com/ go/antigentest

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Ryan Dennis, now six, was diagnosed with severe combined immunodeficiency (SCID), a genetic condition that made him immunocompromised and at high risk of illness. SCID, pronounced “skid,” is one of the 400+ rare, chronic disorders, known as primary immunodeficiencies (PI), where the body’s immune system functions improperly.

Ryan was diagnosed when he was six days old after a newborn screening test detected the condition. SCID is typically fatal within the first two years of life unless the patient receives an immune-restoring treatment, like a bone marrow transplant or gene therapy.

“A simple cold might turn into pneumonia, and then the baby usually dies, because there’s nothing to fight off that infection,” said Bridget Dennis, Ryan’s mother.

PHOTO: COURTESY OF THE DENNIS FAMILY

The Dennis family lived in quarantine and practiced social distancing long before the COVID-19 pandemic.

Living With an Immune Deficiency Disorder Pre- and Post-Pandemic Isolation The Dennis family immediately started isolating after his diagnosis. The isolation paid off, and Ryan stayed healthy. At seven months old, he received a bone marrow transplant from a German donor.

“It treated his issues and gave him a fully working immune system,” Dennis said. “So now he is living life as a normal little boy.”

Ryan spent 43 days in the hospital.

He then visited the hospital 3-4 times a week following his release. He spent 15 months recovering. In total, Ryan spent 22 months in isolation with his family.

Become the doctor you would want caring for you. your family. your friends. your community.

The family re-entered life with baby steps. Just when they were getting comfortable, the COVID-19 pandemic happened. They re-adopted their old habits including frequent hand washing and isolation.

These days, Ryan, who loves soccer, reading, and Captain America, has fully-functioning cells.

Community The Immune Deficiency Foundation (IDF) has been a helpful resource for the Dennis family. The nonprofit works to improve the diagnosis, treatment, and quality of life for people with PI.

Dennis has been an active member of IDF’s SCID group. She wants to help future generations of parents and children who have the condition.

“SCID is not a death sentence,” she said. “It’s scary, but it’s doable. n Kristen Castillo

Acknowledgement/Disclaimer: This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $2.97 million with 0% financed with nongovernmental sources.

The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.

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colleges of osteopathic medicine

Learn more about becoming a Doctor of Osteopathic Medicine (DO) at ChooseDO.org

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The Lack of Equitable Access to HIV Prevention and Treatment This month marks 40 years since the Centers for Disease Control and Prevention (CDC) published its first report on HIV in the United States, and the story has been one of both deep tragedy and powerful triumph.

Since the first cases of AIDS were reported, the disease has claimed more than 700,000 lives in the United States alone. At the peak of the epidemic in the mid-1980s, there were over 130,000 new HIV infections each year. Since then, investments in HIV prevention and treatment have

allowed us to dramatically reduce new infections, and by 2019, there were less than 35,000 new infections nationally.

A lack of equitable access While this is extraordinary progress, success has not been equal in all populations. As the epidemic evolved, profound disparities by race and ethnicity emerged that persist today. African Americans face rates of infection that are more than eight times higher than white Americans, and Hispanic/ Latino populations face rates that are

almost four times higher. We can and must do better.

We have witnessed major breakthroughs in HIV treatment and prevention during the history of this epidemic. As a young doctor in New York City in the 1990s, I personally witnessed the miraculous transformation of HIV from a possible death sentence into a manageable, chronic disease, thanks to improved medications.

An impressive array of prevention tools has also emerged, including CDC’s recommendation that everyone between the ages of 13 and 64 get

tested for HIV at least once as part of routine health monitoring, as well as the identification of medication that can prevent HIV infection, called pre-exposure prophylaxis, or PrEP. HIV testing is critical to ending the epidemic because it is the bridge to all HIV treatment and prevention. PrEP is highly effective in preventing HIV transmission from sex or injection drug use when it is taken as prescribed.

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What Every Facility Needs for Reopening Imagine knowing if SARS-CoV-2, or other in-air pathogens, were detected in your workspace.

That game-changing technology is here and it’s helping businesses return to work.

The AerosolSense™ Sampler by Thermo Fisher Scientific is a new pathogen surveillance solution designed to deliver timely and highly reliable insight into the presence of in-air pathogens, including Flu A/B, SARS-CoV-2 and RSV B. It’s already in use across the United States, Europe, and Asia.

The sampler collects aerosol samples of ambient air and traps in-air pathogens on a collection substrate.

Secured within a cartridge, the substrate is sent to a laboratory for polymerase chain reaction (PCR) analysis.

Customers can use a Thermo Fisher Scientific testing laboratory partner for results in 24 hours or less or use their own laboratory for results in four hours or less.

Reducing anxiety Data has shown how quickly in-air viruses can spread. John Lesica, president of the Chemical Analysis Division for Thermo Fisher Scientific, is optimistic that as the vaccines roll out and COVID-19 cases drop, more people will be comfortable going back into indoor settings. Still, there’s anxiety about safety.

“Having robust safety protocols along with environmental surveillance solutions is going to help address that anxiety and help ensure we can reopen in a safe manner,” says Lesica.

Peace of mind As more organizations reopen, additional measures will be in place, such as individual COVID-19 testing. The AerosolSense Sampler is a complementary next step.

The Sandwich Fire Department in Massachusetts has been using the sampler since fall of 2020. It was especially valuable during the peak of the pandemic when first responders were transporting COVID-19 patients. When the sampler identified SARS-CoV-2 at

the department all employees working those days were rapid tested. A positive individual was identified after testing.

“It gave them the peace of mind that the equipment’s working and the testing program that we had was working,” says fire chief John J. Burke.

“Overall, it’s very successful.” n Kristen Castillo

To learn more visit: www.thermofisher.com/aps.

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Looking forward To help ensure these strategies reach those in need, particularly during the COVID-19 pandemic, the HIV community is advancing innovative solutions designed to reach people where they are.

These innovations include expanded self-testing, increasing the number of mobile options for service delivery, and creative community outreach to those disproportionately affected by HIV. To reach the finish line, we need to accelerate efforts to provide equitable access to HIV prevention and care for everyone. This requires that we address the root causes and social determinants that contribute to disparities among people with HIV, such as poverty, unequal access to healthcare, lack of education, stigma, systemic racism, and work circumstances.

To do this, HIV prevention and care efforts must go outside traditional healthcare settings in ways that respond to community needs, including: • Providing or linking to services like transportation, housing, employment, mental health, or substance use disorder treatment services necessary to access and stay in care.

• Giving people one place to pursue their health needs and engage in care, whether that be for substance use disorder, sexual health, or HIV. • Engaging people in need of care with love and respect, rather than defining them by their HIV status or risk.

We know what we need to do. We believe 10 years from now, with the infusion of new resources, community innovation, and collective commitment, we will celebrate new triumphs as we reach ever closer to health equity and ending this epidemic once and for all. n Demetre Daskalakis, M.D., Director, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention

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Applying the Lessons of HIV and COVID-19 to Build a Healthier World

Twenty-twenty, a year that marked the fourth decade of the American HIV epidemic, opened promisingly, with a federal plan to stop transmission of the virus before the end of a fifth decade.

However, the COVID-19 pandemic disrupted progress.

With improved surveillance, implementation of proven biomedical prevention measures, and a cross-government approach — all bolstered by new funding — the United States’ initiative to end the HIV epidemic for good offered a strategy for ending one epidemic, as well as a roadmap for countering future public health threats.

Instead, the new public health threat of COVID-19 profoundly disrupted services to detect, prevent, and treat HIV, while highlighting gaps in our public health infrastructure that leave us vulnerable to emerging and re-emerging diseases.

While discouraging, events since the emergence of COVID19 and developments since the first reports of what we now know as AIDS, have shown us what we still can do to end HIV as an epidemic in the United

States. If we apply those lessons, we also can make our country better prepared for the next pathogen of pandemic potential.

of discovery — apply not only to HIV research but to the entire biomedical and public health enterprise.

Supporting the science The mobilization that sped development of vaccines against COVID-19 would not have been possible without investments in biomedical research and development spurred by efforts to find prevention, treatments and a cure for HIV. In addition to yielding life-saving therapies and proven prevention measures, HIV research highlighted the role that affected communities must play in driving and shaping research.

Addressing social determinants Unstable and inadequate housing, employment, income, and education have fueled HIV and are central to the disproportionate impact of COVID-19 on racial and ethnic minority populations. Ensuring healthcare coverage and access for everyone, including the more than 2 million lowest income individuals in the 14 states that have not implemented Medicaid expansion, will be pivotal to treating people with HIV and preventing new transmissions.

Delayed responses to the emergence of AIDS in the United States and the belated response to the global HIV pandemic have demonstrated that we cannot afford to wait when confronted with an existential threat. The devastating spread of COVID-19 reminds us again of the consequences of inaction. By acting now and investing fully, we can end HIV as an epidemic in the United States — and set the course toward a healthier nation and world. n

Nothing About Us Without Us Greater investments are needed toward improved long-acting antiretroviral treatments, care for people aging with HIV, and toward an HIV cure and a vaccine. We must address barriers to clinical trial participation for the populations heavily impacted

by HIV to optimize the impacts of scientific discovery. The lessons — the importance of public/private investments toward a common goal; that equity must be woven into the fabric

Rajesh T. Gandhi, M.D., FIDSA

Self-Testing: A New Opportunity for Addressing Infectious Diseases

By now, we are used to monitoring our health at home. Fitness trackers, glucose monitors, and at-home pregnancy tests are just a few examples of ways people keep track of their health daily from the comfort of their own home. This ease of access has now extended to testing during the COVID-19 pandemic.

S

elf-testing, or using self-collected samples for testing, is a relatively new healthcare procedure that is gaining more popularity. Although these rapid tests are sometimes less accurate than those conducted in a traditional healthcare setting, they are still a useful diagnostic tool, and should be a more normalized option for individuals who want to know their current health status.

One of the early surprises of the pandemic was how rapidly COVID-19 spread among asymptomatic individuals.

With self-testing, people can check their status regardless of the presence of symptoms.

This can also be useful for seasonal influenza, where symptoms such as fatigue

may not be recognized as out of the ordinary.

The benefits of self-testing There are currently selftests available for HIV and other sexually transmitted infections (STIs), such as chlamydia, gonorrhea, and hepatitis. Some provide results in minutes, and other tests require that a self-collected sample be shipped to a lab for results in several days.

For STIs, individuals may not feel comfortable going in-person to see their provider for an STI test. With the privacy of an at-home test, more people may be willing to get tested and may do so sooner, which can reduce the health consequences of an infection, as well as potentially reduce the number of people the

infected person could come in contact with following a diagnosis.

Challenges ahead However, connecting at-home testing with public health has been one of the challenges of the COVID-19 pandemic.

Ideally, individuals should report their test results to their provider or the health department. They may also need to isolate and inform their contacts of their COVID-19 status.

Testing also becomes an opportunity to offer other health services, such as vaccinations to the individual and any of their contacts if needed.

Self-testing is just the first step of self-care. Just as an individual testing positive on a pregnancy test or displaying high glucose levels

would need to connect with their healthcare provider for care, self-testing for infections also requires follow-up. For example, residents in Washington, D.C. who use at-home tests with the GetCheckedDC program receive their results along with an invitation from the clinic to follow up for treatment or prevention as needed. Following up with the clinic ensures that the patient gets the care they need. This linkage is also important so that public health departments can track infections and potential outbreaks.

Health departments should be automatically notified of any positive results so they can take appropriate action, such as contact tracing via disease intervention specialists.

Despite these challenges,

self-tests are incredibly convenient because they can be used anywhere. They are especially useful in rural settings, where individuals may have long drives to the nearest clinic.

Increased access saves time and money, especially if an in-person visit is not needed.

The potential of self-testing lies far beyond COVID-19 or STIs, as it can be useful for seasonal influenza or other common infections. Accurate, convenient self-testing connected to existing care systems can help ensure that the next outbreak does not become the next pandemic. n

Geetika Nadkarni, Director, Chronic Infectious Disease, The Association of State and Territorial Health Officials (ASTHO) MEDIAPLANET

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Recognizing the Value of Antibodies as Researchers Explore COVID-19 Symbiotica, Inc.’s Susan Zneimer and Donna Hongo underscore the critical need for antibody testing during and after the COVID-19 pandemic.

“This novel coronavirus is new to the human population, so there are many unknowns about how we should respond to it,” Hongo explained. “Some people make many antibodies that are very good at recognizing the antigen and binding to it. Other people make antibodies, but they’re not as effective at binding to the pathogen, providing only partial protection. There are also some people producing very little or very poor-quality antibodies.”

After the first wave of vaccinations, periodic testing will be essential to determining how long COVID-19 antibodies remain in immune systems in order to prevent further infections.

“To end this pandemic, it is not enough to test for COVID19 infection status or get vaccinated,” said Zneimer. “It is also very important to realize that people need to have antibody protection in order not to get infected again for the virus.”

Cindy Riley

What We Know About Vaccine Development Post-COVID-19 What are the lessons learned from the COVID-19 response for treating new emerging infectious diseases?

Scientists began work on the COVID-19 vaccine in January 2020.

Dedicated vaccine funding helped move vaccine candidates through the pre-clinical and clinical assessments at an unprecedented speed, enabling researchers to advance into phase III clinical trials in six months instead of the typical two years. This speed was accomplished through several modifications to the typical drug development cycle. The lessons learned through these modifications, among dozens of other biotechnology-focused topics, were discussed at the 2021 American Association of Pharmaceutical Scientists’ National Biotechnology Conference, held virtually in May 2021.

Emergency measures Operation Warp Speed provided $18

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READ MORE AT FUTUREOFPERSONALHEALTH.COM

billion in funding for development of vaccines that were intended for the United States populations. This funding allowed vaccine producers to eliminate money as a constraint and accelerate scope and timing for viable treatment candidates. This public-private partnership has included vaccines and monoclonal antibody treatments, and it has enhanced manufacturing capacity and raw material supply. This allowed for the manufacture of at-risk clinical materials before clinical data was available, as well as for the production of commercial product prior to approval for distribution. Front loading of many manufacturing activities was critical to the rapid response. Harmon used these strategies to reduce the timeline for cell line transfection to first human dose from a typical 17 months to two months.

Additionally, the Emergency Use Authorization (EUA) process allows the department of Health and Human

Services (HHS) to request the Food and Drug Administration (FDA) authorize unapproved medical products to be used as counter measures in public health emergencies. These requests were initially focused on terrorism and worries of a potential biological or radiation weapon being used against the United States.

An expedited response Over time, legislation has addressed how the EUA process works, but at its core, it starts with the emergency declaration from the HHS secretary after concluding that there is a public health emergency that could be a threat. The FDA moves EUA reviews to the top of the queue and employs an all-hands-on-deck resourcing approach to get the reviews done quickly. For example, the ribonucleic acid (RNA) lipid nanoparticles and their ability to be applied to new indications — like COVID-19 mRNA vaccines — was recently authorized under an EUA. Related, parallel workflows were recently used to rapidly deliver monoclonal antibody therapeutics for COVID-19.

Another major consideration for approval is the availability of longterm safety data, and whether the shortened development time compromises patient safety.

Even though unlimited money may not be available for every disease, the COVID-19 experience does show that there are lessons to be learned for drug developers. n Phillip Ramsey, M.S., and Vibha Jawa, Ph.D.

Symbiotica is a full suite laboratory solution providing consulting and laboratory services. Our clinical laboratory specializes in providing at-home, selfsampling to increase patient access, easing patient concerns while providing convenience, and empowering patients and healthcare professionals.

How the Right Respirator Fit Testers Can Protect Healthcare Workers More than ever, healthcare professionals know the importance of a properly fitted respirator.

“COVID has raised everybody’s awareness of respiratory protection, and the need for respirators to fit in order to provide protection and safety,” says Greg Olson, M.S., global product specialist for Industrial Hygiene and Respiratory Protection at TSI Incorporated, a key player in the global respirator fit testing market.

Under OSHA’s Respiratory Protection Standard, employers are required to ensure healthcare personnel have initial fit tests for the same make, model, style, and size respirator they’ll be using for personal protective equipment. The fit tests must be repeated annually, and whenever there is a change in the respirator or significant changes to the wearer’s facial shape.

The respirator must properly fit the worker to provide the expected level of protection from COVID-19 and other infectious diseases. “That respirator

has to fit, or it’s not going to protect,” says Olson.

TSI’s PortaCount® Respirator Fit Testers can help ensure that the highest respiratory protection levels are achieved through a properly sized and correctly donned respirator. Olson says this test, “acts as the final exam in the implementation of your respiratory protection program.”

Fit factor According to Long Yang, a technical sales specialist for TSI, a fit test measures three things: that the respirator model is a good match to the facial features of the worker, that it’s the right size, and that it’s worn/ donned properly.

He says often people think any N95 respirator will automatically protect them but that’s not the case. A poor quality N95 respirator or one not sized correctly or worn improperly is very likely to fail the PortaCount® quantitative respirator fit test.

There are two primary OSHA-accepted ways to fit-test respirators: quali-

tatively and quantitatively. With a qualitative test, which takes 20-25 minutes, a tester wears a hood and is exposed to 75-225 nebulizer squeezes of either a Saccharin (sweet) or Bitrex™ (bitter) tasting challenge agent. “If you taste it, then there’s a leak,” says Long, noting the qualitative test is subjective and can be messy.

The PortaCount® respirator fit test is a quantitative test that can test all types of respirators, including N95 respirators.

It only takes two minutes, 29 seconds to complete, requires significantly less prep and set up time, and respirator wearers can get a real-time look at their fit with features like FitCheck® Mode. The PortaCount® Respirator Fit Tester is not just a fit tester, it is a training tool as well. No other fit test methods can be used to provide respirator donning training, which is an essential advantage for Administrators in implementing their Respiratory Protection Programs.

Improved respirator protection While a National Institute of Occupational Safety and Health study con-

firmed any fit test method significantly improved respirator protection, they found quantitative testing with the PortaCount® Respirator Fit Testers of N95 simulated workplace protection factors was the most impactful.

The PortaCount® Fit Tester was the only tested method in the study in which 100 percent of the test subjects exceeded the OSHA Assigned Protection Factor of 10, meaning the air inside the respirator was 10 times cleaner than the air outside the respirator “You want to make sure that you have the best equipment that’s easy to use and that your employees will trust,” says Long, noting TSI provides training and tech support too. n Kristen Castillo

Find out more about TSI’s respirator fit testing equipment at tsi.com/essential

N95 + PROPER FIT AND USE = MAXIMUM PROTECTION To learn more about the PortaCount Respirator Fit Tester, visit tsi.com/essential.

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