The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Guardant Health, Scientia Vascular.
Out of 922 biopharma financings so far in 2020, nearly a quarter of them – 211 – were done by companies working on a COVID-19 therapeutic or vaccine. More strikingly, however, the $27.8 billion raised by those pandemic-focused firms represents about 40% of the $71.8 billion total collected through the end of July. That amount is the highest BioWorld has ever tracked.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cardiacsense, Joimax, Scientia Vascula, Surmodics, Vela Diagnostics.
Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
