The U.S. National Institutes of Health recently announced a competitive grant opportunity for testing for the SARS-CoV-2 virus, which has been characterized as a “Shark Tank-like” program, and NIH director Francis Collins said in a May 7 Senate hearing that one of the criteria for awards is whether supplies can be made readily available for that test, the lack of which has been a significant impediment to testing in the U.S.
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 challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. The state of COVID-19 testing as a regulated sector is a complex intersection of new and old technologies, questionable accuracy, availability hurdles, supply chain interruptions and problems with interpretation of 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.
CEO Carsten Brunn said Selecta Biosciences Inc. has “not seen a material impact” from the COVID-19 pandemic and remains on track to report in the third quarter phase IIb data from a head-to-head trial comparing its refractory gout candidate, SEL-212, with Krystexxa (pegloticase), from Horizon Therapeutics plc, of Dublin.