The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without the need to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected nasal swab […]
Quidel Corp.
Quidel opens new COVID-19 antigen test factory in Calif.
Quidel Corp. (NSDW:QDEL) yesterday said it has opened a manufacturing facility in Carlsbad, Calif. to produce its QuickVue line of COVID-19 rapid antigen tests. The new 128,000 sq. ft facility will become the San Diego-based company’s highest-volume production plant. It will begin operations during the second half of 2021 with a goal of producing 600 million […]
BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
Becton Dickinson (NYSE:BDX) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2. The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth […]
Quidel wins EUA for COVID-19 test with faster runtime
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 […]
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 […]
