Abbott (NYSE:ABT) has received FDA emergency use authorization for a molecular test for novel coronavirus (COVID-19). The company said yesterday that it will immediately ship 150,000 of its RealTime SARS-CoV-2 EUA tests to existing customers in the U.S. Customers can use the tests on Abbott’s m2000 RealTime system, and Abbott will deploy additional m2000 systems as needed. […]
Diagnostics
FDA lets states approve COVID-19 tests
The FDA has issued an unprecedented new guidance that allows individual states to approve diagnostic tests for COVID-19. The guidance also describes a policy regarding the use of serological testing for antibodies to the virus without an emergency use authorization (EUA). The new guidance allows commercial manufacturers to more rapidly distribute their validated SARS-CoV-2 diagnostics […]
Quest Diagnostics, Quidel Corp. get emergency nod for COVID-19 tests
The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
Hologic, LabCorp gain FDA emergency testing nods
The FDA has granted emergency use authorization for COVID-19-related diagnostic tests to Hologic (NSDQ:HOLX) and Laboratory Corporation of America (NYSE:LH). Hologic described its new Panther Fusion SARS-CoV-2 assay as a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19. The automated Panther high-throughput system is widely used across the U.S., can provide results […]
COVID-19 test development surges with pandemic
Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories […]
OtoNexus raises $9.8m
OtoNexus Medical Technologies filed an amendment to its SEC Form D last week to confirm the sale of nearly $10 million in an equity offering. The Seattle-based ultrasound technology maker sold approximately $9.77 million of an $18.2 million offering, leaving just over $8.4 million remaining to be sold, according to the filing. OtoNexus made the […]
Precipio closes Poplar Healthcare OncoMetrix hematopathology division buy
Specialty diagnostics company Precipio (NSDQ:PRPO) announced today that it completed the non-cash acquisition of, among other transactions, the customer base of Poplar hematopathology division called OncoMetrix. The purchase involves no exchange of cash or equity, so it won’t provide a non-dilutive impact to shareholders, according to a news release. Precipio noted that successful implementation without disproportionate […]
BD seeks authorization for COVID-19 tests
Becton Dickinson (NYSE:BDX) said today it will submit an emergency use authorization request this week to the FDA for a coronavirus test that could be used on the BD Max molecular diagnostic system. The diagnostic system is used in hundreds of laboratories across the U.S., according to the company. “BD is also exploring the development of […]
Mayo Clinic develops coronavirus test with results in 24 hours
Mayo Clinic announced that it has developed a test to detect the SARS-CoV-2 virus that causes COVID-19. The individuals undergoing the Mayo Clinic test could receive their results within 24 hours, according to Mayo Clinic’s clinical virology laboratory director Matthew Binnicker. That compares with the several days to a week patients have been waiting for […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
J&J’s Janssen, Thermo Fisher Scientific to collaborate on oncology diagnostic
Thermo Fisher Scientific (NYSE:TMO) announced today that it entered into an agreement with Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech to co-develop a companion diagnostic (CDx) in oncology. Under the agreement, Thermo Fisher is set to collaborate with Janssen’s R&D scientists to validate biomarkers for use with Thermo Fisher’s Oncomine DX target test in identifying variant-positive patients for […]