As states in the U.S. move past the initial push for tests to identify active COVID-19 infections, antibody tests are ramping up quickly to aid in disease surveillance and return-to-work screenings. The rush has spurred an explosion in serology tests, many hastily developed and of questionable value. However, as the pandemic enters its third month, some companies are offering high-accuracy tests with validated results.
The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Camber Spine, Grifols, Neumodx, Sherlock Biosciences.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Qbit, 3M, Advanced Biological Laboratories, Apteryx, Apple, Baebies, Coala Life, Copan Diagnostics, Eurofins Technologies, Fu-Rui, Genalyte, Gold Standard Diagnostics, Invitae, Irras, Novatec Immundiagnostica, Physiq, Senseonics, Shanghai Echosens Medical Equipment Technology, Stratasys, The Henry M. Jackson Foundation for the Advancement of Military Medicine, Thermo Fisher Scientific, Varian Medical Systems, Virotec Diagnostics, Vystar, Wuxi Hisky Medical Technologies.
Keeping you up to date on recent developments in diagnostics, including: Circulating progesterone and breast cancer risk; Llamas aid in fight against COVID-19; Transcriptomic insights into Parkinson’s disease.
CAJICA, Colombia – A research team at the Autonomous University of Queretaro (UAQ), Mexico, is working to develop a COVID-19 vaccine, joining about 100 other teams working toward a similar goal. Unlike other teams, however, this one is being led by veterinarians.
The U.S. FDA continues to modify its emergency use authorization (EUA) policy for testing for the SARS-CoV-2 virus, although workplace testing is still on the agency’s to-do list. The FDA’s Tim Stenzel noted on a May 6 briefing that serological tests for antibodies must now demonstrate an overall sensitivity of 90% and overall specificity of 95%, a set of standards that might challenge some tests that are available under the EUA policy.
