NEW YORK — PixCell Medical said on Wednesday that it has struck a Canadian distribution agreement for its point-of-care HemoScreen CBC analyzer following the instrument's approval in that country.
The effort, called SepTech, will begin on Sept. 1 and run through August 2029, and it picks up from an earlier project called ECLIPSE.
The test is intended to support rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.
NEW YORK – Roche announced on Wednesday that it has received US Food and Drug Administration approval for the expanded use of two companion diagnostic tests with Jazz Pharmaceuticals' Ziihera ...
The firms will integrate their technologies into a single workflow and jointly engage in initiatives to raise awareness of AI-based precision oncology testing.
NEW YORK – Using technology developed at Johns Hopkins University, startup Hypermelt aims to develop tests for the early detection of cancer with improved sensitivity over existing technologies. To ...
BillionToOne has launched its Northstar Origin test, a liquid biopsy add-on assay for tissue-of-origin prediction, as well as an expanded 102-gene version of its Northstar Select panel. Northstar ...
The firm recently raised $15 million in seed financing to further validate and commercialize its pathogen detection and antimicrobial resistance profiling platform. Recent catalysts such as an FDA ...
NEW YORK – Blood-based testing continues to expand within neurology as researchers and clinicians pursue less expensive and less invasive tools for diagnosing and managing neurodegenerative disease.
IVD Makers Brace for Potential Impact From China Volume-Based Procurement Program on Tests, Reagents
NEW YORK – The Chinese in vitro diagnostic market can be difficult to enter for smaller diagnostic firms that do not have an established presence in the country, and a recently expanded program ...
NEW YORK — Proscia said on Thursday that its Concentriq AP-Dx digital pathology software has received 510(k) clearance from the US Food and Drug Administration for use with Leica Aperio GT 450 DX ...
NEW YORK – Researchers at Harvard University's Wyss Institute have developed a digital CRISPR platform and an assay to simultaneously detect pathogenic Candida auris and SNPs conferring drug ...
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