ProPhase Labs (NSDQ:PRPH) announced today that it is introducing a new saliva-based test for COVID-19, Influenza A, B and more. Garden City, N.Y.-based ProPhase Labs said in a news release that it filed for FDA emergency use authorization for its two new testing methodologies, which integrate the Spectrum Solutions saliva self-collection system with a new […]
Spectrum Solutions
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
FDA authorizes at-home collection for Rutgers’ saliva-based COVID-19 test
FDA announced today that it has expanded the previous EUA it granted for the saliva-based COVID-19 test out of Rutgers University — allowing people to collect samples at home and return the samples to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The news comes just weeks after FDA authorized an at-home COVID-19 […]
FDA approves first saliva-based coronavirus test
The FDA granted emergency use authorization (EUA) to Rutgers University’s RUCDR Infinite Biologics and its collaborators for an approach using saliva as test biomaterial for COVID-19. In tandem with Spectrum Solutions and Accurate Diagnostics Labs, RUCDR developed the saliva collection methods as an alternative to nose and throat swabs when testing for SARS-CoV-2, the virus […]
