FDA warns of false results from Curative COVID-19 test January 4, 2021 -- A SARS-CoV-2 test from testing startup Curative can produce false results, in particular false-negative readings, according to a warning issued January 4 by the U.S. Food and Drug Administration (FDA).
FDA allows Enzo to test up to 5 COVID-19 swabs at once January 4, 2021 -- Enzo Biochem has received an expansion of its emergency use authorization from the U.S. Food and Drug Administration (FDA) to use pooled swab samples with the company's Ampiprobe SARS-CoV-2 test system.
Bruker launches microbe test kit following FDA clearance January 4, 2021 -- Bruker has announced the U.S. launch of its MBT Sepsityper kit for rapid microbial identification of more than 425 microorganisms from positive blood cultures. The kit recently received clearance from the U.S. Food and Drug Administration (FDA).
Gamma announces Astrea, Avacta partnership December 23, 2020 -- Life sciences firm Gamma Biosciences has announced a licensing agreement between chromatography developer Astrea Bioseparations and biotherapeutic and reagent developer Avacta.
Bayer and Veracyte team up on thyroid cancer genomic profiling December 22, 2020 -- Bayer and Veracyte are planning to work together on the genetic testing of patients with metastatic thyroid cancer. They will target patients whose disease is radioactive iodine refractory and who may be candidates for therapies targeted at particular mutations.
Quidel nabs EUA from FDA for SARS-CoV-2 antigen test December 21, 2020 -- Quidel has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue point-of-care assay that detects the nucleocapsid protein antigen of the SARS-CoV-2 virus from anterior nares swab specimens.