Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Eurofins’ CE-Marked INgezim dual-recognition immunochromatographic assays […]
Beckman Coulter COVID-19 antibody test receives FDA EUA
Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay. Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE […]
FDA warns against using certain COVID-19 tests
The FDA issued a statement recommending that clinical laboratories and healthcare providers stop using COVID-19 antibody tests on its “removed” list. Found under the FDA’s FAQs on Testing for SARS-CoV-2 page, the removed list includes tests for which significant clinical performance problems were identified and cannot or have not been addressed by the manufacturer in […]
Beckman Coulter wins CE Mark for COVID-19 antibody test
Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe. Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the […]
FDA revokes EUA for COVID-19 antibody test
The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns. Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer […]
Mayo Clinic launches test to detect COVID-19 immunity
Mayo Clinic announced that it launched a new SARS-CoV-2 neutralizing antibody test in support of efforts to establish therapies and vaccines for COVID-19. As part of the Expanded Access Program for Convalescent Plasma and other critical research efforts, Mayo Clinic intends to make the test available to select labs, blood banks and biopharma clients later […]
ThermoGenesis files for patent on device to improve COVID-19 antibody detection
ThermoGenesis Holdings (NSDQ:THMO) announced today that it filed patent applications for its point-of-care COVID-19 antibody detection device. Rancho Cordova, Calif.-based ThermoGenesis’ device is designed to improve the speed and accuracy of lateral flow immunoassays (LFIA) in detecting COVID-19 IgM and IgG antibodies from a single drop of blood. In a news release, ThermoGenesis chief technology […]
DOJ charges medtech exec with fraud over COVID-19 tests
The U.S. Dept. of Justice announced that it charged Arrayit president March Schena for alleged involvement with fraudulent claims for allergy and COVID-19 testing. In a news release, the DOJ alleged that Schena participated in schemes to mislead investors, manipulate Arrayit’s stock price and conspired to commit health care fraud in connection with the submission […]
Former FDA chief scienctist faults agency over COVID-19 antibody test ‘chaos’
FDA allowed both qualified and unqualified entities to flood the market with COVID-19 antibody tests, and the result was “chaos,” FDA’s former chief scientist Jesse Goodman told a U.S. House subcommittee. A month after FDA tightened oversight of the tests and started withdrawing tests from the market, there is still enough concern about false results that the […]
Hologic says its Q3 financial outlook has improved
Hologic (NSDQ:HOLX) announced that the financial outlook for its current fiscal third quarter has improved since it reported its second-quarter results. In April, Hologic reported profits of $94.8 million, or 36¢ per share, on sales of $756.1 million for the three months ended March 28, falling in line with Wall Street projections. In the company’s report, […]
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