NEW YORK (360Dx) – Diagnostics companies have shown a high level of interest in the European Commission's Horizon 2020 program focused on test development, with a focus on cancer, infectious diseases, and circulatory diseases dominating the submitted projects.
Of the 1,194 Horizon 2020 proposals received between 2014 and 2017, most were related to the development of markers and devices for in vitro diagnostics, while a third were focused on personalized medicine.
Jean-Luc Sanne, a scientific officer at the European Commission, carried out the analysis, which appeared recently in the journal Personalized Medicine. Sanne oversees IVDs at the health directorate of the Commission's directorate-general for research and innovation in Brussels.
"I have been in charge of the diagnostics area for more than 10 years and now I deal more with personalized medicine," Sanne said of his motivation for the study. "I had therefore interest in the outcome of this call."
As discussed in the paper, between 2014 and 2017, the European Commission released €130 million ($150 million) through its Horizon 2020 program to support small- and medium-sized enterprises (SMEs) focused on clinical research for the validation of biomarkers or diagnostic devices. The financial instrument is somewhat comparable to the US National Institutes of Health's small business innovation research program.
The applications came at a time of transition for European regulations governing IVDs. By 2020, the majority of test developers must comply with a new directive, called the IVDR, a process that entails obtaining clearance from an EU-certified organization called a notified body (NB). Based on the existing regulations, many of the same tests have been deemed suitable for clinical use following a self-certification process with limited oversight. As part of the clinical evaluation to obtain a CE mark under the new system, manufacturers must present data demonstrating the clinical and analytical accuracy for their products to these certifying NBs.
As noted in the report, the new regulations will increase the burden on SMEs to validate biomarkers, which was one of the reasons the Commission decided to release the funding, and perhaps why the high level of interest in the funding call surpassed initial expectations.
"We expected hundreds" of proposals, said Sanne. "We got 1,200."
Sanne noted that clinical development for SMEs in Europe in general remains a "long and risky" process and that it has been difficult for companies to obtain funding to carry out test development from the private sector.
"The attrition rate in the clinical validation of biomarkers is sometimes compared to the attrition rate in drug development," Sanne said. "Because the health sector is rather regulated, access to market is longer than in other sectors."
The new regulations created an additional burden on SMEs developing tests though. Based on Sanne's analysis of the proposals, he concluded that one aim of applicants was to comply with the new regulations, either to obtain or to renew market authorization.
"It was not always clear in the proposals whether the proposed devices were already on the market," Sanne noted. "However, many of them were apparently on the market, either for research purposes or for diagnostics," he said. "Some proposers claimed they wanted to comply with the new regulation or gain recognition in the clinical setting thanks to clinical validation."
The high level of interest in the funding instrument meant that fewer projects were funded than might have been. While roughly 14 percent of the proposals were funded with sums of €50,000 for an initial, six-month-long feasibility assessment phase, the percentage of proposals funded for a second phase, which typically ran five years and included support of on average €3.3 million, was much lower, at 3.9 percent.
The lower number of projects funded through the second phase could also be attributed to the high cost of clinical evaluation studies, the report noted.
"If the ultimate number of proposals funded was low, it’s because our budget was limited, although substantial, considering the requested financial contribution per project," said Sanne.
A third of the proposals submitted focused on cancers, while 13.5 percent focused on infectious and parasitic diseases, followed by 12.7 percent focused on cardiovascular diseases. Projects focused on metabolic, digestive, neurological, and genitourinary diseases each received about 5 percent of the total funding.
As noted in the report, the focus on infectious diseases was disproportionate to clinical needs in Europe, where cancer, neuropsychiatric conditions, and cardiovascular diseases are the dominant conditions. Sanne said that the projects focused on infectious diseases were aimed at serving not just the European market, but the global market for such tests.
"The infectious diseases market is important worldwide and accessible to SMEs," said Sanne. "Another thing is that biomarkers for infection diseases are identified on the pathogens," he said. "There are fewer doubts about their validity than for biomarkers of complex diseases like neuropsychiatric conditions, and I think it [is] more straightforward for an SME."
About 65 percent of the proposals were related to projects focused on IVDs, while 13 percent were focused on medical imaging. Roughly 42 percent of proposals concerned devices designed for use in clinical laboratories. About a quarter were focused specifically on the development of a diagnostic instrument.
Twenty-seven percent of the proposals analyzed were related to point-of-care devices, a trend that might reflect changes in the IVD market favoring POC devices, according to the report. In terms of personalized medicine, Sanne found that personalized medicine objectives were predominant in 35 percent of the proposals analyzed. Such projects ranged from prognostic assays, such as OncoMark's OncoMasTR test, to predictive monitoring tests, such as Biovica's DiviTUm for gauging breast cancer treatment response.
Sanne said the interest in personalized medicine projects "surprised" him, as he expected more projects focused on simple companion diagnostics with the codevelopment of a drug and a diagnostic, as opposed to tests that could be used to monitor patients over time and inform treatment decisions at every turn.
"I did not expect a high proportion of proposals in personalized medicine," said Sanne. "These proposals addressed stratification for generic medicines, prevention, or early monitoring for the therapeutic strategy to the patient's characteristics and response to treatment."
In the paper, he suggested that the focus on personalized medicine may have been an attempt by SMEs to "overcome the uncertainties of the companion diagnostics business model" such as alignment issues between drugs and diagnostic test development. European SMEs, he wrote, might instead be favoring the development of tests for "comprehensive companion diagnostics."
The extent of the interest and breadth of the diagnostics projects funded through Horizon 2020 led Sanne to conclude that there is continued need for financial support for validating diagnostic markers and devices. As to what kind of support SMEs focused on diagnostics might expect after the conclusion of Horizon 2020 in two years, Sanne said it is still difficult to say. The Commission has published a proposal for a program to succeed Horizon 2020, called Horizon Europe, which would last seven years and allot €100 billion for research and innovation projects.
"Let's wait and see," he said of future funding opportunities.