The finalized local coverage determinations were set to go into effect on Feb. 23 but have been pushed back two months.

Last week, readers were most interested in a story about Roche gaining FDA clearance and CLIA waiver for its STI point-of-care test.

The molecular test is used to differentiate bacterial infections, viral infections, and noninfectious disease and to assess ...

Laboratory Corporation of America has launched its MS Monitoring Profile test, which combines the measurement in blood of the biomarkers neurofilament light chain and glial fibrillary acidic protein ...

Roche plans to release the system in the US to run tests including vitamin D and steroid assays under CLIA before it possibly receives US Food and Drug Administration clearance.

NEW YORK – Early-stage women's health diagnostics firm PinkDx announced on Thursday that it has completed a second close of its $45 million Series A financing round.

The organization is leveraging its growing bank of whole-slide pathology images to create models that could form the backbone of cancer testing applications.

The FDA granted marketing clearances for infectious disease tests, updates to a digital pathology system, and immunoassays for chronic diseases.

Abbott reported $9.34 billion in diagnostics revenues in 2024, down 7 percent on a reported basis from $9.99 billion in 2023 and down 4 percent on an organic basis. Excluding COVID-19 testing-related ...

The partners plan to expand testing for early detection of childhood leukemias and lymphomas, bolster local testing capacity, and conduct a research study.