FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website. Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision […]
Genomics/Molecular Diagnostics
FDA issues EUA for LumiraDx point-of-care COVID-19 antigen test
LumiraDx announced today that it received FDA emergency use authorization (EUA) for its LumiraDX SARS-CoV-2 point-of-care antigen test. London-based LumiraDx’s test is designed to detect antigen nucleocapsid protein from a nasal swab and provide results in less than 12 minutes from sample application in symptomatic patients, according to a news release. In clinical studies, the […]
Accelerate Diagnostics gains EUA for rapid coronavirus antibody test
Accelerate Diagnostics (NSDQ:AXDX) and BioCheck announced that they received FDA emergency use authorization for their COVID-19 antibody test. The BioCheck SARS-CoV-2 IgM and IgG combo test and fully-automated MS-Fast instrument that received authorization can process human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection, according to a news […]
FDA warns on false results for Thermo Fisher TaqPath COVID-19 testing kit
The FDA today issued a warning for labs and healthcare providers due to a risk of false results with a Thermo Fisher Scientific (NYSE:TMO) COVID-19 test kit. Results from the Thermo Fisher TaqPath COVID-19 Combo Kit may be false, based on two issues related to the test kit and the associated Applied Biosystems COVID-19 interpretive software, […]
PerkinElmer launches high-volume COVID-19 test workstations
PerkinElmer (NYSE:PKI) announced today that it launched a series of Explorer workstations for increasing COVID-19 testing capabilities. Waltham, Mass.-based PerkinElmer touts its Explorer workstations as capable of preparing and running up to 10,000 COVID-19 tests per day, enabling laboratories to ramp up their testing for the SARS-CoV-2 virus causing coronavirus and generate quick results. Get the […]
FDA approves saliva test for COVID-19
Over the weekend, the FDA issued emergency use authorization (EUA) for the Yale School of Public Health’s SalivaDirect COVID-19 test. Yale’s diagnostic test uses a new method of processing saliva samples when testing for COVID-19 infection without requiring a special swab or collection device, as the saliva can be collected in any sterile container. The […]
MedTech 100 roundup: Up-and-down week for industry
Medtech stocks highlighted the topsy-turvy nature of the market last week, but ultimately finished the seven days nearly unchanged. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.77 points at the end of last week (Aug. 14). Overall, medtech stocks saw a 0.13% increase from the […]
HHS puts $6.5M more toward COVID-19 testing
The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month. The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) […]
BREAKING: Thermo Fisher drops bid for Qiagen
Thermo Fisher Scientific (NYSE:TMO) announced today that its offer to acquire Qiagen (NYSE:QGEN) in an $11.5 billion deal has lapsed. According to a news release, more than 107.5 million shares of Qiagen (47.02% of the issued and outstanding ordinary shares for the company) were validly tendered into the offer by the end of the acceptance period on […]
Verily launches clinical lab for COVID-19 testing
Google’s (NSDQ:GOOGL) Verily announced that it established a CLIA-certified lab to create additional lab capacity to support COVID-19 testing. The lab, at Verily’s San Francisco headquarters, is designed to support programs in the COVID-19 testing space as demand continues to increase while the pandemic goes on, including the company’s own return-to-work efforts for its own employees, […]
DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production
The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test. Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release. BioFire’s COVID-19 test received FDA emergency use authorization […]