Under the deal, Labcorp will acquire BioReference's laboratory testing businesses focused on clinical diagnostics and reproductive and women's health in certain states.
The lateral flow immunochromatographic assays may be performed by CLIA-certified labs, as well as at the point of care.
The company uses highly sensitive biosensors to detect volatile organic compounds in breath that may indicate lung cancer.
Dissatisfaction with the soon-to-be released FDA rule on LDTs has prompted legislators to reconsider the VALID Act and other possibilities for LDT oversight.
The company recently published a study in JAMA on the test and is in the middle of two additional clinical trials as it closes a $6 million Series A funding round.
Canadian diagnostic firm Stemcell Technologies announced on Tuesday that its hematopoietic cell enrichment kit has received de novo classification from the US Food and Drug Administration.   The ...
Last week, readers were most interested in a story about Siemens Healthineers shutting down FTD, which it acquired in 2017.
The qPCR-based test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with chronic myeloid leukemia to determine their response to treatment.
NEW YORK – The US Department of Justice said Tuesday that a Florida lab owner has pleaded guilty to his role in defrauding Medicare by billing for over-the-counter COVID-19 tests and genetic tests ...
NEW YORK – Chugai Pharmaceutical announced on Wednesday that Japan's Ministry of Health, Labour, and Welfare has approved Roche's FoundationOne CDx Cancer Genomic Profile test to identify patients who ...
NEW YORK — Polymedco said on Wednesday its PathFast Biomarker Analyzer for diagnosing myocardial infarction at the point of care has been 510(k) cleared by the US Food and Drug Administration.