Kantaro Biosciences announced today that it received FDA emergency use authorization (EUA) for its COVID-SeroKlir antibody test. New York-based Kantaro, a joint venture between Mount Sinai Health System and RenalytixAI (NSDQ:RNLX), developed the semi-quantitative SARS-CoV-2 IgG antibody test kit to determine the presence and precise level of IgG antibodies related to COVID-19. A partnership with […]
Genomics/Molecular Diagnostics
Hologic gains FDA nod for HIV test
Hologic (NSDQ:HOLX) announced that it received FDA approval for a diagnostic claim for its HIV-1 viral load monitoring assay. Marlborough, Mass.-based Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., according to a news release. Initially approved in 2016 for viral load monitoring, […]
BD adds informatics option to its COVID testing platforms
Healthcare providers who use the Becton Dickinson (NYSE:BDX) BD Veritor Plus and BD Max COVID-19 testing platforms have a new informatics option. BD announced today that it has launched new reporting capabilities for COVID-19 data, enabling its BD Synapsys informatics to generate scheduled reports. BD Veritor Plus is a portable instrument designed to deliver SARS-CoV-2 antigen […]
FDA OKs first COVID-19 test that people can use on themselves at home
The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test. A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release. Lucira’s test is authorized […]
Canada to buy 7.6M BD rapid COVID-19 tests
Becton Dickinson (NYSE:BDX) announced that Health Canada authorized its rapid COVID-19 tests and will buy 7.6 million of them. Under interim order, Health Canada authorized BD’s rapid, point-of-care SARS-CoV-2 antigen test for use with the BD Veritor Plus system. The order for 7.6 million tests runs through March 2021 in an effort to support Canada’s planning […]
COVID-19 vaccine rally sees testing companies’ stocks dip
News of Pfizer and BioNTech’s COVID-19 vaccine candidate performing well has caused markets to rally this week. The two companies are collaborating on a vaccine candidate that has proven in early clinical data to be approximately 90% effective, and the news helped to propel MassDevice’s MedTech 100 Index to a new record high yesterday. However, […]
Joe Biden’s plan for COVID-19 and how the industry is reacting
Following the weekend’s news that Joe Biden is now president-elect of the U.S., plenty of focus is shifting to his plan for COVID-19. While positive news regarding Pfizer and BioNTech’s vaccine candidate came through this morning, the pandemic is still roaring on, with the U.S. hitting a record 128,000 new cases on Saturday as the […]
Report: Some nursing homes refuse to use COVID-19 rapid antigen tests
Many rapid COVID-19 tests are going unused in nursing homes as there reportedly remain concerns over accuracy in detecting the virus. The Wall Street Journal reports that a federal survey of nursing homes found that 30% of 13,150 facilities that had rapid testing equipment for at least two weeks did not use it to test […]
MedTech 100 roundup: Stocks show no signs of slowing down
The medtech industry hit further highs in the market last week and the stocks show no sign of stopping their ascent now. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 97.62 (Nov. 6), marking a 7.3% leap from the 91.01 points registered at the […]
FDA issues EUA for GenScript’s COVID-19 neutralizing antibody detection kit
GenScript announced today that it received FDA emergency use authorization (EUA) for its cPass SARS-CoV-2 neutralizing antibody detection kit. Piscataway, N.J.-based GenScript touts its test as the first commercially available diagnostic for specifically detecting neutralizing antibodies without the use of live virus. It measures the presence of neutralizing antibodies in any sample, both in patients […]
Mesa Biotech lands $13M to develop rapid COVID/flu test
Mesa Biotech announced today that it was awarded $13 million by BARDA to develop its COVID-19 and flu molecular diagnostic. San Diego-based Mesa Biotech received the contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and […]
