preeclampsia
The company has been offering the test on a limited basis but now plans to market it more broadly after a large validation study showed high sensitivity and specificity.
Roche Preeclampsia Assay Nabs FDA 510(k) Clearance
The prognostic test stratifies hospitalized women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia.
Trinity Biotech to Acquire Metabolomics Dx for $1.3M in Cash and Stock
Trinity plans to bring to market in 2025 Metabolomics Diagnostics' PrePsia test that can be used to determine preeclampsia risk in the 12th week of pregnancy.
QuidelOrtho Gets Health Canada Approval for Triage Preeclampsia Test
The approval is for an assay to detect biomarkers that may indicate the likelihood of developing preeclampsia during a pregnancy.
The Foundation for the National Institutes of Health is leading a public-private collaboration that could help make available in the US tests that are sold in Europe.