Study revises thinking on genes and breast cancer risk January 22, 2021 -- Women who have mutations associated with breast cancer are not necessarily at higher risk as previously thought, according to a large review of epidemiology studies published January 20 in the New England Journal of Medicine.
Qiagen plans FDA resubmission of coronavirus rapid antigen test January 21, 2021 -- Qiagen is planning a first-quarter resubmission of its QIAreach rapid antigen test to the U.S. Food and Drug Administration (FDA). In separate news, the company said that its molecular diagnostics are effective for detection of the various known strains of the coronavirus.
FDA commissioner Hahn leaves agency January 20, 2021 -- Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration (FDA), has left the agency. He is being replaced on an interim basis by longtime FDA regulator Dr. Janet Woodcock. Discuss
HHS outsources review of some lab-developed COVID-19 tests January 20, 2021 -- The U.S. Department of Health and Human Services (HHS) has decided to outsource some review of lab-developed tests (LDTs) for COVID-19 to private companies. HHS has issued one of the first contracts for external review of LDTs to NDA Partners of Rochelle, VA.
Hexapod personal protective booths cut testing costs for COVID-19 January 19, 2021 -- As the COVID-19 pandemic continues to evolve, hospitals and labs have had to get creative, overcome hurdles, and adapt their practices to perform safer COVID-19 testing. One solution is the Hexapod, which is a personal protective booth that allows healthcare providers to undertake swab testing without physically contacting patients. Discuss
Ortho files for IPO to sell 70M shares January 19, 2021 -- Ortho Clinical Diagnostics has filed for an initial public offering (IPO) that aims to sell 70 million shares at a price between $20 and $23 per share. The company's shares will be traded on the Nasdaq stock exchange under the symbol "OCDX."