Quidel Corp. (NSDW:QDEL) announced that it received FDA emergency use authorization (EUA) for its Solana SARS-CoV-2 assay. San Diego-based Quidel’s Solana SARS-CoV-2 assay is an isothermal reverse transcriptase-helicase-dependent amplification (RT-HDA) assay designed for the qualitative detection of nucleic acid from the virus causing COVID-19 in nasopharyngeal and nasal swab specimens, according to a news release. Testing […]
Quidel Corp.
COVID-19 vaccine rally sees testing companies’ stocks dip
News of Pfizer and BioNTech’s COVID-19 vaccine candidate performing well has caused markets to rally this week. The two companies are collaborating on a vaccine candidate that has proven in early clinical data to be approximately 90% effective, and the news helped to propel MassDevice’s MedTech 100 Index to a new record high yesterday. However, […]
Report: Some nursing homes refuse to use COVID-19 rapid antigen tests
Many rapid COVID-19 tests are going unused in nursing homes as there reportedly remain concerns over accuracy in detecting the virus. The Wall Street Journal reports that a federal survey of nursing homes found that 30% of 13,150 facilities that had rapid testing equipment for at least two weeks did not use it to test […]
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 […]
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.
