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 […]
Quidel Corp.
Report: BD, Quidel struggle to supply antigen tests for COVID-19
Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal. The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep up with […]
States band together to purchase BD, Quidel antigen tests for COVID-19
Seven U.S. states have formed an interstate compact with the Rockefeller Foundation to expand the use of rapid point-of-care antigen tests to better manage the COVID-19 pandemic. The compact — announced yesterday by a bipartisan group of governors leading the states — includes Louisiana, Ohio, Maryland, Massachusetts, Michigan, North Carolina and Virginia. The idea is that […]
NIH puts $249m into new COVID-19 tests
The National Institutes of Health (NIH) announced today that it is investing $248.7 million in new technologies to address challenges with COVID-19 testing. The “Rapid Acceleration of Diagnostics” (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by […]
FDA authorizes Quidel antigen test for rapid COVID-19 detection
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.
