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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Designed for ease of use in near-patient settings, the cobas liat assays require minimal training, ensuring rapidness for healthcare professionals. The closed system design of cobas liat also ...
Express Healthcare1d
GlobalData highlights implications of US tariffs on IVD market
According to GlobalData, these tariffs are expected to impact all 510(k)-approved medical devices manufactured outside of the ...
Indianapolis Business Journal10d
Roche Diagnostics hopes new self-collection HPV test will expand screening for cervical cancer risk
The test, one of the first of its kind, is designed to reach patients who may forgo traditional screening because of lack of ...
pharmaphorum1mon
FDA approves Roche’s lung cancer liquid biopsy test
The US Food and Drug Administration (FDA) has approved Roche’s cobas epidermal growth factor receptor (EGFR) Mutation Test v2. The decision makes it the first FDA-approved, blood-based genetic ...