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Vermillion Files 510(k) with FDA for Ovarian Tumor Triage Test

NEW YORK (GenomeWeb News) – Vermillion said today that it has filed for clearance from the US Food and Drug Administration for its OVA1 Ovarian Tumor Triage Test.
The OVA1 test was developed as part of an alliance between Vermillion and Quest Diagnostics.
The Fremont, Calif.-based molecular diagnostics firm said in March that the OVA1 test had met its primary endpoints in a clinical study, and the company expected to file for FDA clearance during the first half of 2008. The test is designed to stratify women with pelvic masses into high-risk and low-risk categories to help determine if they should be referred to a specialist prior to surgery.
Vermillion also is working with Quest on a lab test for peripheral artery disease that will incorporate its protein biomarkers, and which it hopes to commercialize this year.
Shares of Vermillion were up 10.7 percent at $2.28 in early Wednesday trade on the Nasdaq.

The Scan

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.

Acne-Linked Loci Found Through GWAS Meta-Analysis

Researchers in the European Journal of Human Genetics find new and known acne vulgaris risk loci with a genome-wide association study and meta-analysis, highlighting hair follicle- and metabolic disease-related genes.

Retina Cell Loss Reversed by Prime Editing in Mouse Model of Retinitis Pigmentosa

A team from China turns to prime editing to correct a retinitis pigmentosa-causing mutation in the PDE6b gene in a mouse model of the progressive photoreceptor loss condition in the Journal of Experimental Medicine.

CRISPR Screens Reveal Heart Attack-Linked Gene

Researchers in PLOS Genetics have used CRISPR screens to home in on variants associated with coronary artery disease that affect vascular endothelial function.