The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing. Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for […]
Diagnostics
Hologic granted second molecular COVID-19 test EUA
Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19. Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours. Hologic said in a news release […]
FDA warns on accuracy of Abbott rapid COVID-19 test
After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results. Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.” A preliminary study released […]
How AI could help health providers diagnose COVID-19
When it comes to diagnosing treating COVID-19, timeliness is imperative to avoid patient deaths. Several companies are developing artificial intelligence-based algorithms to help doctors analyze and diagnose COVID-19 in patients quickly. The coronavirus has affected more than 3.7 million people globally, with the U.S. experiencing the most COVID-19 cases at just over 1.2 million so […]
Abbott rapid COVID-19 test results questioned again
A new study by researchers at New York University has found that a COVID-19 rapid diagnostic made by Abbott (NYSE:ABT) missed up to 48% of positive results, renewing questions about its accuracy. This is the same test and lab equipment used at the White House, according to published reports. The study, conducted at NYU’s Langone Tisch […]
Day Zero Diagnostics wins $6.2m from accelerator
Day Zero Diagnostics announced that it received an award of up to $6.2 million in non-dilutive funding from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The funding from the non-profit partnership dedicated to accelerating early antibacterial R&D is intended to support Day Zero’s diagnostic system designed to help physicians diagnose and treat life-threatening bacterial infections. […]
FDA grants Abbott EUAs for diagnostic, antibody testing platforms
The FDA so far this week has granted Abbott (NYSE:ABT) two emergency use authorizations (EUAs) allowing diagnostic and antibody tests to run on the company’s Alinity systems. The agency today authorized Abbott’s COVID-19 molecular diagnostic test for use on its new Alinity m molecular laboratory instrument. Abbott said it has begun launching the Alinity m system […]
BREAKING: BD stops selling COVID-19 antibody test it touted in March
Becton Dickinson (NYSE:BDX) said today that it has stopped selling a point-of-care test touted as being able to detect antibodies to COVID-19 in as little as 15 minutes. The test, by BioMedomics, was one of about 100 serological tests that the FDA allowed manufacturers to sell beginning March 26, 2020, if the companies self-validated their accuracy. […]
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 […]
Biomerica wins CE Mark for high-volume, 10-minute COVID-19 test
Biomerica (NDSQ:BMRA) announced that it received CE Mark and is launching a high-volume production version of its COVID-19 rapid test. Irvine, Calif.-based Biomerica’s IgG/IgM rapid test uses the finger-prick method to test blood with results obtained within 10 minutes. The test can be performed by trained professionals anywhere. The company’s new high-volume version of the […]
FDA authorizes at-home collection for Rutgers’ saliva-based COVID-19 test
FDA announced today that it has expanded the previous EUA it granted for the saliva-based COVID-19 test out of Rutgers University — allowing people to collect samples at home and return the samples to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The news comes just weeks after FDA authorized an at-home COVID-19 […]