FDA has issued a first-of-its-kind emergency use authorization for Quidel‘s COVID-19 antigen test, which enables rapid diagnosis of virus infection. San Diego–based Quidel describes the Sofia 2 SARS Antigen FIA as a rapid point-of-care test to be used with the Sofia 2 fluorescent immunoassay analyzer. It can produce results in 15 minutes. Cardinal Health, Fisher […]
The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
Abbott (NYSE:ABT) said today that it launched the tender offer for its $5.3 billion acquisition of diagnostics giant Alere (NYSE:ALR). The $402-per-share tender offer is slated to expire at midnight on August 11, Abbott said. The merger was amended in April, when Abbott agreed to pay $5.3 billion for Alere rather than the original price of $5.8 billion. Get […]
Becton Dickinson & Co. (NYSE:BDX) won FDA 510(k) clearance for its BD Veritor 10-minute diagnostic test for influenza A and B last month, amid rumors that the Franklin Lakes, N.J.-based company is ripe for buyout.
Veritor is the first rapid flu test with a digital readout, while older tests are slower, less accurate and more difficult to interpret, according to BD.
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Here’s a quick rundown of a few releases over the past couple days:
Quidel Corp. (NSDQ:QDEL) landed a nod from the Food & Drug Administration for its new pregnancy test platform.
The RapidVue dipstick-format pregnancy immunoassay will be the San Diego-based diagnostics company’s fourth product launched this year, according to a press release.
By Mary Vanac
Started in 1983 by a group of Ohio University professors, Diagnostic Hybrids was spun out of the university to commercialize its sophisticated diagnostic tests used mostly by hospital and reference laboratories.