The American Society for Microbiology (ASM) has developed an online platform to identify COVID-19 and non-COVID testing supply shortages. In partnership with the Associaton for Supply Chain Management (ASCM), ASM developed the platform to identify and monitor the testing supplies to be made aware of shortages in real-time, according to a news release. The tool […]
Genomics/Molecular Diagnostics
The top 5 MassDevice stories of the week — October 16, 2020
For the second consecutive week, medtech giant Medtronic (NYSE:MDT) managed to dominate the news on MassDevice. The company’s “Investor Day” brought about several headlines, including new clinical trials ahead and a rallying cry from CEO Geoff Martha. Other news that garnered some attention came in the form of a new ultrasound system from another big player […]
Cue Health lands $481M from HHS for COVID-19 test
The federal government has awarded startup Cue Health $481 million to increase domestic production capacity of point-of-care testing for COVID-19. The money from the Department of Health and Human Services and the Department of Defense will enable San Diego, Calif.-based Cue to manufacture 100,000 COVID-19 test kits per day by March 2021, including 6 million […]
Abbott wins FDA EUA for COVID-19 IgM antibody test
Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for its IgM antibody serology test for COVID-19. The AdviseDx SARS-CoV-2 IgM lab-based serology test runs on the Architect and Alinity platforms to detect antibodies in response to the virus, indicating a recent or prior infection. Abbott Park, Ill.-based Abbott’s latest test is the company’s […]
FDA amends Hologic EUA for asymptomatic COVID-19 test
Hologic (NSDQ:HOLX) announced that its Aptima SARS-CoV-2 assay now has authorization for testing individuals without symptoms. Aptima received FDA emergency use authorization (EUA) in May as a COVID-19 test, and this week the FDA amended the EUA to include testing for asymptomatic individuals or those with other reasons to suspect COVID-19 infection, according to a news […]
Abbott defends rapid COVID-19 test with interim trial results
Abbott (NYSE:ABT) has launched another defense of its ID NOW rapid COVID-19 diagnostic test, this time with interim clinical trial results that confirm assertions the company made in May. A total of 1,003 people were evaluated in urgent care clinics, hospitals and nursing homes, where Abbott said ID NOW delivered the following results compared with those […]
LabCorp molecular COVID-19 testing method wins FDA EUA
Laboratory Corporation of America (NYSE:LH) announced today that received FDA emergency use authorization for its new COVID-19 testing method. Burlington, N.C.-based LabCorp’s new, high-throughput method uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing in an effort to improve the speed and efficiency of RT-PCR tests for the virus, according […]
FDA authorizes first oral-rinse COVID-19 diagnostic
Access Genetics & OralDNA Labs announced today that it received FDA emergency use authorization (EUA) for its oral-rinse COVID-19 test. Eden Prairie, Minn.-based Access’ OraRisk COVID-19 RT-PCR test allows for testing from a saline oral rinse collection. Samples of the test are viable for up to 72 hours and don’t require cold pack transportation while […]
BD wins CE mark for 15-minute COVID-19 diagnostic test
Becton Dickinson (NYSE:BDX) announced today that it received CE Mark approval in Europe for its rapid COVID-19 test. Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test — used on the BD Veritor Plus system — delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a […]
Report: Canada to buy 7.9M Abbott COVID-19 tests
The Government of Canada announced today that it agreed to buy up to 7.9 million Abbott (NYSE:ABT) ID NOW rapid point-of-care COVID-19 tests. Canadian Minister of Public Services and Procurement Anita Anand, along with Minister of Health Patty Hajdu, announced the agreement for the tests, although the purchase still hinges on Health Canada authorization for the […]
BioAffinity Technologies CEO Maria Zannes talks cancer detection, women in medtech
Maria Zannes and her company BioAffinity Technologies are seeking to up the game on lung cancer detection. Here’s how. Maria Zannes’ path to a leading role in the medtech field wasn’t quite a conventional one. The one-time aspiring journalist carved out a role on Capitol Hill, first as an aide, then as a lobbyist, plus […]