Mesa Biotech announced today that it was awarded $13 million by BARDA to develop its COVID-19 and flu molecular diagnostic. San Diego-based Mesa Biotech received the contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and […]
Genomics/Molecular Diagnostics
Study: Abbott antigen test can detect COVID-19 in asymptomatic people
A study out of Spain found that an antigen test made by Abbott (NYSE:ABT) is capable of detecting COVID-19 infection in asymptomatic people. Antigen-based rapid diagnostic tests are seen as a potential alternative to the standard for COVID-19 diagnosis, the RT-qPCR test, which has drawbacks including the need for laboratory processing, high cost and some long […]
Eurofins launches SARS-CoV-2 test kit
Eurofins (Paris:ERF.PA) announced today that it launched the GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) kit for COVID-19 testing. Luxembourg-based Eurofins’ test kit uses the fragment length analysis principle on Sanger sequencing instruments, such as the ABI 373xl, with the assay enabling each sequencer to process more than 2,000 samples per day while the kit provides sensitivity […]
BD beats The Street in Q4, posts 2021 guidance
Becton Dickinson (NYSE:BDX) reported Street-beating fourth-quarter financial results and revealed its 2021 fiscal guidance. The Franklin Lakes, N.J.-based company posted profits of $128 million, or 36¢ per share, on sales of $4.8 billion for the three months ended Sept. 30, 2020, for a -21.5% bottom-line slide on sales growth of 4.4%. Adjusted to exclude one-time items, […]
Hologic rises on Street-beating Q4
Hologic (NSDQ:HOLX) shares got a boost today on fourth-quarter results that topped the consensus forecast. The Marlborough, Mass.-based diagnostic company posted profits of $495 million, or $1.88 per share, on sales of $1.35 billion for the three months ended Sept. 26, 2020, for a massive bottom-line gain from the red on sales growth of 55.6%. Adjusted […]
FDA flags false-positives with COVID-19 antigen tests
The FDA announced today that it is alerting laboratory staff and healthcare providers of false-positive results for rapid COVID-19 antigen tests. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2 antigens in authorized specimen types collected from individuals suspected of COVID-19 by their healthcare provider within a certain number of days of symptom […]
Hologic receives $119M contract from U.S. Air Force for COVID-19 molecular tests
Hologic (NSDQ:HOLX) announced that it received a $119 million contract from the U.S. government to expand production of its COVID-19 tests. Under the contract, Hologic will increase the production capacity of its Panther Fusion SARS-CoV-2 assay and Aptima SARS-CoV-2 assay, both of which possess emergency use authorization, according to a news release. The tests run on […]
Thermo Fisher Scientific continues growth trajectory
Thermo Fisher Scientific (NYSE:TMO), the maker of scientific instruments, reagents and consumables, is having a banner year. The Waltham, Mass.-based company’s stock has hit an all-time high of $481.99. That amounts to a 48% increase since the beginning of the year. Thermo Fisher raked in $2 billion in COVID-19 revenue from July to September, driving a […]
Advamed: Diagnostic COVID-19 tests shipments hit 200M
Total U.S. shipments of COVID-19 molecular diagnostic tests have reached 200 million, according to AdvaMed’s COVID-19 diagnostic supply registry. A breakdown of the data shows that diagnostics companies are shipping, on average, more than 1.4 million molecular tests each day. “For the past few months, our diagnostics companies have made it clear they’ll do whatever […]
FDA issues EUAs for two at-home COVID-19 tests
Two companies announced today that they received FDA emergency use authorizations (EUAs) for at-home COVID-19 diagnostic tests. Eurofins (Paris:ERF.PA) and DxTerity Diagnostics each received the authorization for separate COVID-19 tests, one of which is nasal-based and the other saliva-based. Luxembourg-based Eurofins’ at-home nasal PCR test is touted as a minimally invasive and quick option that offers […]
MedTech 100 roundup: Industry continues its ascent
Stocks in the medtech industry maintained their upward trajectory, topping last week’s peak with yet another rise to new heights. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 95.66 (Oct. 16), marking a 0.6% gain from the 95.05 points registered at the end of […]