Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing […]
Genomics/Molecular Diagnostics
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn […]
FDA issues EUA for Helix COVID-19 NGS test
Helix announced today that it received FDA emergency use authorization (EUA) for its Helix COVID-19 next-generation sequencing (NGS) test. San Mateo, Calif.-based Helix’s NGS test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 (the virus causing coronavirus) in upper respiratory specimens from individuals suspected of having COVID-19 by their healthcare provider, according […]
FDA revokes Autobio antibody test EUA
The FDA issued a letter announcing that it revoked the emergency use authorization (EUA) for a COVID-19 test from Autobio Diagnostics. Autobio’s SARS-CoV-2 rapid antibody test received EUA on April 24 for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood or serum. Authorization for the […]
MedTech 100 roundup: Another high as stocks tick up
For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from […]
FDA issues EUA for Vela Diagnostics COVID-19 PCR test
Vela Diagnostics announced that it received FDA emergency use authorization (EUA) for the manual version of its coronavirus PCR test. Fairfield, N.J.-based Vela designed its COVID-19 diagnostic to target conserved regions of the viral genome so the probe-based reverse transcription PCR test detects SARS-CoV-2, the virus causing COVID-19. The ViroKey test is conducted through nasopharyngeal […]
Becton Dickinson slides on mixed-bag Q2, declining revenue projections
Becton Dickinson (NYSE:BDX) shares took a big hit today on second-quarter results that were mixed compared to the consensus forecast. BDX shares were down -8.5% at $259.32 in mid-morning trading today. The Franklin Lakes, N.J.-based company posted profits of $286 million, or 97¢ per share, on sales of $3.85 billion for the three months ended June […]
MedTech 100 roundup: Industry hits another mid-pandemic high
Despite a minor regression week-over-week, the medtech industry’s stocks hit another milestone as the COVID-19 rebound remains in progress. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.01 points at the end of last week (July 31). Overall, medtech stocks saw a -0.3% increase from the […]
NIH puts $249m into new COVID-19 tests
The National Institutes of Health (NIH) announced today that it is investing $248.7 million in new technologies to address challenges with COVID-19 testing. The “Rapid Acceleration of Diagnostics” (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by […]
New Quest lab method gains FDA nod
Quest Diagnostics (NYSE:DGX) announced that it received FDA emergency use authorization (EUA) for a new laboratory technique for extracting viral RNA. Secaucus, N.J.-based Quest Diagnostics’ new technique is designed to speed up the process of extracting viral RNA from specimens in an effort to expand daily capacity of COVID-19 molecular diagnostic tests in the U.S., according […]
Sorrento licenses COVID-19 saliva test
Sorrento Therapeutics (NSDQ:SRNE) announced that it entered into a licensing agreement with Columbia University for its COVID-19 saliva diagnostic test. The one-step diagnostic test is designed to detect SARS-CoV-2 (the virus causing coronavirus) in as little as 30 minutes from a sample of saliva. Developed by a team at Columbia, the test will be marketed […]