The tests are intended for infectious and chronic disease detection and diagnosis as well as to aid in routine health monitoring.
NEW YORK – The Centers for Medicare & Medicaid Services issued a request for information Thursday seeking public input on potential updates to the Clinical Laboratory Improvement Amendments of 1988 ...
Roche announced on Tuesday that it its Cobas hepatitis D test has been CE marked and the company is launching it in countries that accept the designation. The high-throughput test is intended for the ...
The Alzheimer's Drug Discovery Foundation (ADDF) said on Monday that it has partnered with the Michael J. Fox Foundation (MJFF) to develop minimally invasive biomarkers for Parkinson's and Alzheimer's ...
Of the roughly 1 million disputes taken through the law's arbitration process in Q2 2025, around 129,000 were for lab codes, with payments for basic tests averaging hundreds of dollars.
Last week, readers were most interested in a story about Roche's blood-based IGRA test for latent TB getting CE marking.
Sapphiros will use the funding to develop its molecular diagnostic platform for biothreat and emerging infectious disease detection in point-of-care settings.
Under the policy, blood-based tests may be eligible for coverage if they either are cleared or approved by the US FDA or measure phosphorylated-tau 217.
The test, along with other research-use tests for neurodegenerative disease, run on the Danaher subsidiary's DxI 9000 Immunoassay Analyzer system.
NEW YORK – Roche announced on Thursday that it's blood-based immunoassay to detect latent tuberculosis infection has received the CE mark. The interferon gamma release assay, or IGRA, runs on Roche's ...
The firm began its early-access program in breast cancer in March and is now expanding the test's indications to include colorectal and renal cancers.
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