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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

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.