Roche's Elecsys sFlt-1/PlGF ratio for predicting preeclampsia risk receives FDA 510(k) clearance
Identifying patients at high risk of developing severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.
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Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
The first and only FDA-approved companion diagnostic for assessing HER2-low status since 2022 is now also approved to aid in the assessment of HER2-ultralow status for patients with MBC.
Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units
The Roche Diagnostics Tina-quant® Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person’s bloodstream (serum and plasma), and will be broadly available on Roche's chemistry systems in the U.S.
Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care
FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.
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