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 – 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 ...
Quest Diagnostics named Adrienne Brott its SVP and chief quality and regulatory affairs officer. She will oversee the firm's quality and regulatory strategy, as well as its efforts complying with US ...
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 – Astek Diagnostics and Key Technologies announced on Tuesday that they have partnered to develop a benchtop analyzer that will be used to diagnose urinary tract infections. The automated ...
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 – Roche announced on Thursday that it has expanded a previous collaboration with Janssen Biotech to create companion diagnostics for targeted therapies. The new agreement allows the companies ...
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 – Roche announced on Tuesday that it has expanded its partnership with the US Centers for Disease Control and Prevention to improve HIV and tuberculosis prevention, testing, and treatment.
NEW YORK – Thermo Fisher Scientific said on Wednesday that it has obtained US Food and Drug Administration clearance for its BRAHMS CgA II KRYPTOR test, a chromogranin A (CgA) immunoassay for ...
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