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UK IVD Industry Hindered by Lack of Funding, Structural Issues, Report Says

NEW YORK – Cambridge Design Partnership and CPI, two UK companies that support technology innovation, this week published a report to support British manufacturers of in vitro diagnostic tests.

The 88-page white paper, called A Strategic Technology Roadmap for the UK In Vitro Diagnostics Industry, was funded by Innovate UK, the UK's national innovation agency. Cambridge Design Partnership produced the report with input from CPI as well as the Association of British HealthTech Industries (ABHI), a UK industry association that supports the health technology community.

As noted in the report, while the UK has been a source of innovative technologies, ranging from lateral flow tests to next-generation sequencing, most of these platforms are developed to the point of commercialization domestically and then sold to global IVD players, many of them US based. While a source of innovation, the UK only accounts for a fraction of the IVD industry.

One reason for this, according to Pari Datta, principal consultant in strategy at Cambridge Design Partnership and lead author of the report, is a lack of capital.

"Funding has been a key problem for UK IVD startups," Datta said in an email. "Consequently, the conventional startup model has been to raise a small amount of investment and develop a system to demonstrate the technology," he said. Datta said that a part of the new report provides ways for which UK companies can receive sufficient funding to break free of this model.

Dan Haworth, head of diagnostics and partner at Cambridge Design Partnership, and Richard Owen, the firm's head of biology, also contributed to Datta's responses.

Improving the position of the UK IVD industry is a priority for the UK government, Datta underscored, particularly in response to the COVID-19 pandemic, which, in his words "highlighted a real gap" in the UK IVD industry, as the UK had to rely on diagnostics produced in other countries, even though the underlying technologies were developed in UK universities.

Datta said that the UK, given its innovation track record, is well positioned to take advantage of nine technologies areas outlined in the report: digital PCR, sequencing, cell-free nucleic acids, digital biomarkers, proteomics, combined biomarkers, single-cell analytics, exosomes, and metabolomics. According to Datta, the UK has "very strong IP" across all nine opportunities. In particular, he singled out the use of digital technologies in diagnostics as an area where the UK has an opportunity to become a global leader, naming digital biomarkers — collected at home to monitor a patients' disease — as well as cell-free DNA-based tests as specific opportunities.

The report also recommends that the UK invest in developing technologies in materials, such as graphene or functionalized chip platforms, in addition to new enzymes, artificial intelligence tools, optics and imaging technologies, microfluidic technologies, and different biosensors.

The UK must also address structural issues that are hindering the uptake of IVDs in the UK, which often cause developers to commercialize them in the EU or in the US first, or to seek external partnerships. The report highlights seven challenges, including a lack of UK infrastructure and ecosystem for design and development, as well as obstacles to collecting patient samples, running clinical studies, commercializing new tests, encouraging their adoption, plus obtaining clinical reimbursement for them, in addition to financing and investment.

Datta noted that introducing new IVDs via the UK's National Health Service, which he described as a "complex organization" based around 219 health trusts in England alone, is challenging, as each trust adopts new tests and realigns its pathways individually, leading to long adoption times.

"Fundamentally, we need to think beyond the NHS to export and commercialize UK R&D more globally," argued Datta.

UK policymakers could also mandate the consistent use of IVDs across NHS trusts, the report argues, and create NHS centers of diagnostic excellence to drive early adoption of new tests.

By addressing the issues that constrain the growth of small and medium-sized enterprises, creating an ecosystem that nurtures talent, and adding larger technology and pharmaceutical companies as potential funders and supporters of domestic IVD ventures, the report's authors believe, the UK can grow its share of the global IVD industry over the coming decade.

Other recommendations, according to Datta, are to attract international IVD firms to the UK for development and manufacturing; to reduce the regulatory burden through "well-defined and harmonized regulatory pathways" for manufacturers; and to reimburse IVD tests by the benefits they deliver, by using a quality-adjusted life year (QALY) approach, as is the case for therapies.

According to Datta, the new report is intended to be used for stakeholders involved in creating the next generation of diagnostics in the UK. These include SMEs, major IVD players, venture capital firms, pharma companies, and big tech companies, he said.