NEW YORK – In the immediate wake of the COVID-19 pandemic, there was initial enthusiasm that over-the-counter self-administered tests would see an upshot as some believed the widespread use of antigen ...
This story has been updated to correct a comment by Diana Marcella Cardona that was mischaracterized in the original version. We regret the error. NEW YORK ...
This story has been updated to note that ACLA has not asked for a preliminary injunction in its suit against FDA. NEW YORK – The American Clinical Laboratory Association's lawsuit last month against ...
NEW YORK – South Korean diagnostic firm Noul said Wednesday that it has inked an agreement to launch its hematology and malaria testing tools in Europe through German lab chain Limbach Group. The ...
NEW YORK – MAWD Laboratories' PCR-based COVID-19 test has received Emergency Use Authorization from the US Food and Drug Administration, according to a notice from the agency posted last week. The ...
NEW YORK – Prior authorization has in recent years become a more common feature of the clinical laboratory landscape as insurers look to control costs, particularly of newer genetic and molecular ...
NEW YORK – With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once ...
NEW YORK – Backed by $49.1 million in US federal funding, Owlstone Medical is expanding into multi-cancer early detection (MCED) testing with plans for a home test that uses breath and urine samples.
NEW YORK – The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).
NEW YORK – The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results ...
NEW YORK – Vela Diagnostics said Monday that Japanese clinical testing company SRL will distribute Vela's HIV-1 drug resistance mutation assay kit in Japan. Under the deal, Singapore-based Vela will ...
NEW YORK – The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and ...
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