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 […]
Diagnostics
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 […]
Abbott touts study showing nearly 100% accuracy of its COVID-19 antibody test
Abbott (NYSE:ABT) today highlighted University of Washington research showing that its COVID-19 blood antibody test had 99.9% specificity and 100% sensitivity among people tested 17 days after the start of symptoms. Abbott has already shipped more than 10 million of the SARS-CoV-2 IgG lab-based serology blood tests around the world for use on the company’s Architect […]
BD ramping up testing capacity for possible second wave of COVID-19
Becton Dickinson is preparing to scale up its manufacturing operations of COVID-19 testing kits for a second wave of infections in the fall, according to Reuters. Franklin Lakes, N.J.-based BD in April received FDA emergency use authorization (EUA) and CE mark approval for its COVID-19 test that returns results in 2-3 hours. The test is […]
Becton Dickinson beats The Street in Q2
Becton Dickinson (NYSE:BDX) shares were up in pre-market trading on Street-beating second-quarter results. The Franklin Lakes, N.J.-based company posted profits of $183 million, or 53¢ per share, on sales of $4.3 billion for the three months ended March 31, 2020, for a massive bottom-line gain from $20 million in profits this time last year on sales […]
AdvaMed’s Whitaker calls for pandemic cooperation
Preparation for future pandemics will require closer cooperation between the medtech industry and the U.S. government, according to Scott Whitaker, CEO and president of the trade group AdvaMed. In an interview on the DeviceTalks Weekly podcast, Whitaker laid out steps he believes the federal government and medtech industry must take, including addressing medical device and […]
PerkinElmer receives EUA for COVID-19 antibodies test
PerkinElmer (NYSE:PKI) announced today that it received FDA emergency use authorization (EUA) for its EuroImmun subsidiary’s COVID-19 serology test. The Waltham, Mass.-based company’s Anti-SARS-CoV-2 ELISA serology test for detecting the IgG antibody in COVID-19 patients is now available for immediate use in clinical laboratories. PerkinElmer and EuroImmun designed the ELISA test to aid in identifying individuals […]
Pavmed completes $4.1m offering
Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of more than $4 million in debt, options, warrants and other rights to acquire securities. The medical device company completed its total offering of approximately $4.1 million, having made its first sale on April 30, according to the filing. It took just one investor to […]
Hologic to launch new COVID-19 diagnostic across U.S.
Hologic (NSDQ:HOLX) announced late this afternoon that it will launch a second high-throughput molecular diagnostic test for the coronavirus (SARS-CoV-2). Investors reacted by sending shares in HOLX up 8.27% in after-hours trading. The Marlborough, Mass.-based company said it aims to produce at least 1 million Aptima tests per week to run on more than 1000 of […]
New Abbott antibody test wins CE Mark in Europe
Reports in the United Kingdom say that a 99% accurate COVID-19 antibody test produced by Abbott (NYSE:ABT) won CE Mark approval for use across Europe. The Abbott Park, Ill.-based company, which has a base in Maidenhead, England, expects to have shipped millions of its lab-based tests across Europe by the end of May, according to a […]
Quest Diagnostics launches patient-ordered COVID-19 antibody test
Quest Diagnostics (NYSE:DGX) announced today that consumers can now order a COVID-19 antibody test it launched last week directly from the company, without visiting a doctor’s office. The Secaucus, N.J.-based testing giant said consumers can purchase the antibody test service online for $119 through its QuestDirect business. They will be prompted to schedule an appointment for […]