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In using the act, the HHS applied priority-rated orders for SARS-CoV-2 diagnostic supply contracts with Becton Dickinson and Quidel through September.
The investment bank said it believes OraSure will obtain an FDA Emergency Use Authorization for its COVID-19 antigen test that could lift its stock price.
As the US tries to get more people tested, rapid antigen tests have moved to the forefront of that effort as they can provide results more quickly than PCR-based tests.
The study currently tests 28,000 people every two weeks and will expand to 150,000 by October, with the aim to increase to 400,000 people across the country.
The chemiluminescent test targets antibodies against the virus' S1 protein which the firm believes is a particularly clinically relevant marker.
The company received Emergency Use Authorization from the US Food and Drug Administration for another SARS-CoV-2 antibody test early last month.
Quidel sued Siemens Healthineers claiming false advertising associated with a competing assay that measures thyroid-stimulating immunoglobins to detect Graves' disease.
About 3.4 million people, or 6 percent of the population in England, was likely infected by SARS-CoV-2 by July 13. People of color had higher rates of infection.
The FDA letters were sent to two firms advertising an antibody home test being sold on two websites and a stool test for SARS-CoV-2.
The three tests are designed to detect antibodies, including immunoglobulin G and M, against SARS-CoV-2 in human serum and plasma.
The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.
The test, which is distributed in the US by Hardy Diagnostics, was found to have a low sensitivity for the IgM target.
The company missed analyst estimates on the top line and provided guidance for its full fiscal year 2020 revenues to decrease 2.5 to 3.0 percent as reported.
The viral assay, developed with Sentinel Diagnostics, improves the ability to monitor viral loads in critical organ transplant populations for the clinical management of infection.
The company posted Q2 revenues of $13.1 million, down from $13.5 million in Q2 2019 but above the consensus Wall Street estimate of $11.8 million.
According to Snibe, the test has 99.6 specificity and 100 percent sensitivity at 15 days following the onset of symptoms for COVID-19.
Antelope is currently developing a urine-based at-home test for the sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae.
The company recorded $111,000 in revenues from its recently launched SARS-CoV-2 antibody test, which runs on its MosiaQ blood testing platform.
CEO Doug Bryant noted, in particular, what he expects will be a hunger for rapid protein-based antigen tests for the coronavirus that the market currently can't fill.
The company's BD Veritor Plus SARS-CoV-2 assay, which has FDA Emergency Use Authorization, is designed to detect viral antigens in nasal swab specimens.