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 […]
Quest Diagnostics, Quidel Corp. get emergency nod for COVID-19 tests
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 launches tender offer for Alere in $5.3B merger
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 lands clearance for 10-minute flu test | Regulatory Roundup
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.
Human Genome Sciences drops deep into the red | Earnings roundup
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
Quidel gains FDA clearance for pregnancy test
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.
Quidel designed the human chorionic gonadotropin-based test to be used with urine samples. The company said test results are available three minutes after use.
Quidel closes Diagnostic Hybrids buyout
By Mary Vanac
ATHENS, Ohio — San Diego diagnostic test maker Quidel Corp. (NSDQ:QDEL) closed its acquisition of Diagnostic Hybrids Inc. for about $130 million in cash.
Quidel Corp. to buy Diagnostic Hybrids for $130 million
By Mary Vanac
ATHENS, Ohio — Quidel Corp., the San Diego, Calif.-based company that makes point-of-care diagnostic tests, agreed to acquire Diagnostic Hybrids Inc. of Athens, Ohio, for $130 million in cash.
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.
