PerkinElmer (NYSE:PKI) announced today that it received FDA emergency use authorization (EUA) for its EuroImmun subsidiary’s COVID-19 serology test. The Waltham, Mass.-based company’s Anti-SARS-CoV-2 ELISA serology test for detecting the IgG antibody in COVID-19 patients is now available for immediate use in clinical laboratories. PerkinElmer and EuroImmun designed the ELISA test to aid in identifying individuals […]
Genomics/Molecular Diagnostics
New Abbott antibody test wins CE Mark in Europe
Reports in the United Kingdom say that a 99% accurate COVID-19 antibody test produced by Abbott (NYSE:ABT) won CE Mark approval for use across Europe. The Abbott Park, Ill.-based company, which has a base in Maidenhead, England, expects to have shipped millions of its lab-based tests across Europe by the end of May, according to a […]
Mayo Clinic COVID-19 test receives EUA
FDA announced this week that it’s granted an emergency use authorization for Mayo Clinic’s real-time polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19. The Rochester, Minn.–based health provider is already running thousands of coronavirus tests daily — with help from diagnostic processors from Roche Diagnostics, that run the Roche Cobas SARS-CoV-2 test. […]
BD wins EUA, CE Mark for COVID-19 test that can return results in hours
Becton Dickinson (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) and CE Mark approval for a new COVID-19 molecular diagnostic test. The test, based on the U.S. Centers for Disease Control assay design and run on the BD Max system, may return results in 2-3 hours, according to the Franklin Lakes, N.J.-based company. […]
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 […]
Novacyt joins collaboration to boost COVID-19 testing in UK
Novacyt announced today that it is collaborating with AstraZeneca (NYSE:AZN), GlaxoSmithKline (NYSE:GSK) and the University of Cambridge to increase testing in the United Kingdom. Pharmaceutical companies AstraZeneca and GSK, along with the University of Cambridge, are slated to set up a new testing laboratory at Cambridge’s Anne McLaren lab. The facility will be used for high throughput […]
Mesa ships 10,000 COVID-19 rapid tests
Mesa Biotech announced today that it is shipping 10,000 of its Accula SARS-CoV-2 molecular rapid point-of-care tests this week for detecting COVID-19. The San Diego-based company’s palm-sized testing platform is designed to enable “near-patient” testing outside a central laboratory with diagnostic results in 30 minutes. Accula uses reverse transcription polymerase chain reaction (RT-PCR) technology to […]
COVID-19 upends medtech’s financial outlook
The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Luminex wins EUA for new COVID-19 diagnostic test
Luminex (NSDQ:LMNX) announced today that it received FDA emergency use authorization (EUA) for its Aries SARS-CoV-2 assay for detecting the virus causing COVID-19. Austin, Texas-based Luminex runs the test on its FDA-cleared Aries system for sample-to-answer, automated, on-demand molecular diagnostics. Aries is capable of running up to 144 tests per day with no specialty training […]
Owlstone Medical appoints new CFO
Breath biopsy device developer Owlstone Medical recently announced the appointment of Neil Tween as its new CFO. Tween joins Owlstone from GW Pharmaceuticals, a publicly listed pharmaceutical company where he served as VP and group financial controller, according to a March 30 news release from the company. Read the full story on our WTWH Media […]
New BD, BioGX coronavirus test can be run on-site at hundreds of U.S. hospitals
Becton Dickinson (NYSE:BDX) and BioGX announced today that the FDA granted emergency use authorization (EUA) to their new diagnostic test for screening for COVID-19 on-site at hospitals. The new test is designed as an easy-to-use, rapid diagnostic test to screen for coronavirus and receive results in under three hours, according to a news release. The assay detects […]