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AVACTA SIGNS DIAGNOSTIC LICENSING DEAL WITH BIOKIT

Avacta, the developer of cancer therapies and diagnostics based on its Affimer and pre|CISION platforms, has entered into a license agreement with Biokit to incorporate Affimer reagents into a Biokit in-vitro diagnostic (IVD) product.

Biokit is recognised as a Centre of Excellence with consolidated experience worldwide in research, development and manufacturing of assays and biomaterial solutions for IVD use.

The license agreement follows an extensive evaluation by Biokit of certain Affimer reagents to detect a key analyte. Under the terms of the agreement Biokit has the right to develop, manufacture and commercialise through original equipment manufacturer (OEM) partners a diagnostic immunoassay for this analyte.

Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development

Avacta will receive royalties on future sales of any products brought to market following completion of product development and regulatory approvals. Financial details of the agreement were not disclosed.

Dr Alastair Smith, chief executive of Avacta Group said: “I am delighted to have established this partnership with Biokit, a world-renowned IVD company, which further validates the Affimer reagent platform for diagnostics. Avacta’s diagnostics business model combines development of a wholly owned pipeline of products, including the SARSCoV-2 rapid antigen test, with licensing of Affimer reagents to diagnostic development partners such as Biokit.

Dr Marta Palicio, innovation director of Biokit added: “Biokit is very pleased to have reached this agreement with Avacta. The agreement will increase the competitiveness of our customised assay offering for our partners. Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development, incorporation of this technology into new products. We hope this is the first of many assays containing Affimer reagents which will be developed by Avacta.”

Perkin Elmer acquires Oxford Immunotec

PerkinElmer has completed its acquisition of Oxford Immunotec after previously announcing its intention in January this year.

Prahlad Singh, PerkinElmer president and chief executive officer, said: “Oxford Immunotec’s global role in fighting tuberculosis, particularly its trademark product, the T-SPOT.TB test, and the operations it has built are remarkable. We recognise the distinct clinical and logistical advantages of the test and see a great opportunity to leverage our automation capabilities and commercial channel access to bring tuberculosis testing to more customers around the world.”

Headquartered in Abingdon, UK, Oxford Immunotec is recognised as a specialist in proprietary test kits for latent tuberculosis. Its Interferon Gamma Release Assay (IGRA) identifies individuals who are infected with tuberculosis.

Period care firm among world’s most innovative

UK-based period-care B-Corp, Callaly has been named to Fast Company’s annual list of the World’s Most Innovative Companies for 2021.

The list honours the businesses that have turned the challenges of the last year into impact-making processes. Callaly was ranked at number 10 in the MIC list’s Design category.

Thang Vo-Ta, co-founder and CEO of Callaly, said: “I couldn’t be more proud on behalf of the whole Callaly team for this recognition. From day one at Callaly our mission has been to make the lives of people with periods better and we have consistently lived up to this promise through our innovations and commitments to quality, sustainability and campaigning. “This year has seen us reach some incredible milestones, from securing FDA clearance and exporting across Europe, to seeing our tampliner, the first design upgrade to the tampon in 80 years, named one of TIME’s Best Inventions of 2020.

“To be recognised in Fast Company’s list alongside such incredible company is testament to the hard work and dedication from everyone here at Callaly and all those who helped us on our journey to-date.”

Manufacturer secures government order for 20m tests

The UK government has secured 20 million Britishmanufactured rapid COVID-19 tests from Derby-based test manufacturer SureScreen Diagnostics.

These lateral flow antigen tests produce a result in under 30 minutes and have been validated by Public Health England (PHE).

The SureScreen test will be used as part of the government’s rapid testing programme for those without symptoms, which has seen lateral flow tests deployed across the country to test NHS and care home staff, as well as in targeted settings including schools, universities and for those who have key worker status.

The tests have been proven to detect the B117 ‘Kent’ variant of COVID-19. Results for the test at the laboratory validation stage show sensitivity against high viral loads was 97.1% and specificity was 99.9%.

Health and social care secretary Matt Hancock said: “Rapid lateral flow tests strengthen our national response to the virus significantly, helping us to identify the around one in three people who are asymptomatic and break chains of transmission in our workplaces and communities. It is excellent to be working with a UK firm to deliver millions more of these rapid tests.”

David Campbell, director of SureScreen, added: “We believe our rapid antigen tests can really help in screening people both in the community and in clinical settings. Routine testing is crucial to help business, as well as hospitals and GPs.”

SureScreen is a member of the UK Rapid Antigen Test Consortium, a coalition of scientists and manufacturers aiming to secure lateral flow tests and manufacturing capability for the UK. Uvamed, manufacturers of Rainbow Trays and Tamper Evident Rainbow Trays for anaesthetic drugs, has won an Innovate UK award to develop the Trauma Tray procedurepack/crash-box.

Trauma Trays are secure and auditable complete procedure packs for use away from regular hospital environments such as rescue services, ambulances, field hospitals, care homes and in emergency departments. The secure tray packs will contain all equipment, supplies and, where appropriate, the drugs required to perform procedures in remote locations.

A usability study led by TM-MIC/MD-TEC (Trauma Management MedTech Cooperative/ Medical Devices Testing and Evaluation Centre), sought specialist opinion from a select group of healthcare professionals working within the field of anaesthesia, regarding imagined use of the product outside of their typical working environment for RSI (Rapid Sequence Induction) procedures. The study suggested a good level of demand and acceptance for the Trauma Tray concept, yielding many key insights for consideration.

Other healthcare professionals have provided significant and effective feedback into the Trauma Tray design, use, function and suitability, the value of which has been fundamental to creating a product that will address the needs of healthcare professionals in their working environments.

Procedures identified that could benefit from a Trauma Tray include: Routine IV cannulation; arterial/central line insertion; tracheotomy; RSI or basic suturing kits.

Funding from the Innovate UK project has allowed Uvamed to develop Trauma Trays to a level where they have two tray types ready for evaluation by end users. An IV cannulation tray for use in a wide range of applications, and a more complex Central Venous Catheter tray to demonstrate the robustness of the design for both simple and complex procedures. Moving forward the company plans to design trays for more procedures including RSI and tracheostomy.

Study finds demand for trauma trays

New PPE face shields developed to help NHS go green

Tecman Advanced Healthcare Products is developing PPE with Optec – a new biomaterial reusable face shield system designed to help the NHS reach its carbon emission reduction targets.

At the start of COVID-19, the urgent need for safe and comfortable PPE to protect frontline healthcare workers enabled British manufacturing to demonstrate incredible agility. But it simultaneously raised concerns about the environmental impact of more disposable commodities.

In a recent survey carried out by Tecman, 90% of the 156 healthcare workers surveyed communicated growing concerns about the environmental impact of PPE.

Tecman’s latest development tackles these concerns head on. Optec reusable face shield system from the Leamingtonbased company is underpinned by its four Pillars of Comfort, addressing the need for safe and comfortable protection that’s not only kinder to the environment but has a lower cost per wear.

Since spring 2020, the Tecman team has been on a mission to make British-engineered protective visors the number one choice for NHS workers and has been working closely with the NHS ever since.

As part of this drive, the company invested over £500,000 in machinery that enabled them to boost production of their protective face shields to over 1 million units per week. In June 2020, its original face shield became one of the first to receive the category III complex design PPE level.

In recognition of the product’s quality and comfort, the company’s face shield is specified by the NHS in its product framework and catalogue, and has already been used by hundreds of thousands of frontline healthcare workers.

Provider collaboratives:

The next big customer group for medtech?

Oli Hudson, content director at Wilmington Healthcare, looks into one of the headline points of the new NHS White Paper, and explores what this might mean for the industry.

‘Integrating care: Next steps to building strong and effective integrated care systems across England’, the White Paper released by NHS England and NHS Improvement in February, had as a central conceit the increased importance of ‘place’ and the role played by providers.

Place is considered in the White Paper to be a locale with a population of 250,000 to 500,000 and is roughly coterminous with a local authority boundary.

‘Places’ are expected to take on delegated budgets, with the ICS (integrated care system) only taking the lead where it is clear that work needs to be carried out over a larger footprint.

Each place would typically have up to five hospital trusts, as well as ambulance, mental health, and community care services, which are now all expected to form integrated structures.

These providers, working in groupings, collaboratively, seem to hold the future of the NHS in their hands, if this document is enacted as is; driving forward pathway change and service improvement and making the NHS ‘financially and clinically sustainable’.

Every NHS provider will be expected to join at least one provider collaborative.

It seems clear these collaboratives will take an ‘active and strong’ leadership role in places. This will not be a totally smooth process, and some will struggle more than others to establish a new way of working after a near quarter century of competition with each other. However, written into this script is a need for provider collaboratives to challenge and hold each other to account.

And ultimately the trauma of coping with the postCOVID backlog and having thinly spread workforce and resources may just force the process here. Collaboratives will need to enact mutual aid arrangements such as collective waiting list management and look at their combined and individual spend to see how they can enhance productivity and improve value for money.

This could affect medtech in a variety of ways.

Firstly, who is the decisionmaking unit that medtech is effectively selling to? In the old model, an account might be a large hospital with its own clinical directorate and its own procurement department. While there would be some aggregate purchasing and plenty of use of the NHS Supply Chain, with provider collaboratives new governance will be in place. Clinical decision making, including an influence on purchasing, will not sit at individual hospital level. What will this mean for a standard medtech account?

Secondly, procurement decisions could well end up in the hands of the so-called ‘lead provider’ a trust within a place that will sign the contract with the regional NHS. In fact, taking on this function is one of the marks of a provider collaborative having gone ‘live’.

It will be important to establish who this lead provider is. For example, in the Nottinghamshire provider collaborative codenamed IMPACT, the lead provider is Nottinghamshire Healthcare NHS Foundation Trust.

The place model will undoubtedly give rise to new pathways, too; both in a clinical sense, in terms of using the resources available within a place to change the model of care, as is being developed by the GIRFT initiative; and in the geographical location of services – in terms of some trusts specialising in particular clinical areas; and rationalisations within place, meaning some service reconfiguration, which could affect what some of your customers are actually carrying out. One of the main priorities of many provider collaboratives, for example, will be to keep patients out of hospital as far as possible.

Lastly, the value proposition could change. Under the old financial system, individual trusts paid on activity and in competition with other providers were effectively incentivised to perform as many procedures as possible, thereby increasing trust revenue. With the new contract-based system, the focus is much more on provider collaboratives achieving outcomes – built into the contract – population health – dependent on equitable provision across the whole system, not just by the individual organisation – and sustainability, meaning a stronger focus on long-term benefits to the place, and system. This last point – perhaps usefully for medtech – could result in less of a focus on short-term cost cutting if those longer-term outcomes are clearly evident from the use of a particular device, technique or product.

This is clearly a space to watch – the next important release from NHSE/I will be its forthcoming publication on provider collaborative models. This is likely to include hospital groups, where trusts will band together in more formal organisations. Could they be medtech’s customers of the future?

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