NEW YORK (GenomeWeb) – Vermillion said after the close of the market on Thursday that the British Standards Institution has awarded the company ISO 13485:2003 certification for its quality management system.
ISO 13485:2003 is the internationally recognized quality standard for medical devices and diagnostics, and is based on quality management principles — such as customer focus, management, internal processes, and external relationships — that enhance organization performance, Vermillion said.
Vermillion President and CEO Valerie Palmieri said in a statement that the certification is a building block for the company's planned international expansion.
Vermillion markets the OVA1 ovarian cancer test. It also is working on its next-generation proteomics-based OVA2 ovarian cancer test, which includes three of the original five OVA1 biomarkers along with two new protein markers.