AUSTIN, Texas, Feb. 12, 2015 /PRNewswire/ -- Vermillion, Inc. (Nasdaq: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today that the Company has been awarded ISO 13485:2003 from the British Standards Institution (BSI), one of the world’s leading certification bodies, for Vermillion’s quality management system. ISO 13485:2003 certification is the internationally recognized quality standard for medical devices and diagnostics.
“Vermillion is committed to quality throughout all aspects of our business,” said Valerie Palmieri, Vermillion’s President & Chief Executive Officer. “The receipt of this certification is an important achievement for Vermillion, and is a reflection of our commitment to our quality and customer experience. This is one of our building blocks for our planned International expansion.”
About ISO 13485:2003
ISO 13485: 2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.
About Adnexal Masses
- 500,000 1 million women experience ovarian masses and 150,000 300,000 women have suspicious ovarian tumors removed annually in the US.
- Ovarian cancer is rarely diagnosed in early stages and has the highest mortality rate of all gynecological cancers.
- Over 70,000 OVA1 tests have been ordered to date.
- Vermillion has launched ASPiRA Labs, a CLIA certified national clinical lab, to serve as a cutting-edge biomarker diagnostics center for gynecological cancers.
About OVA1
- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and trigger the involvement of a specialist (gynecologic oncologist) for higher risk patients
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical “risk score” that stratifies patients into “higher risk” and “lower risk” when combined with clinical assessment
- In two pivotal clinical trials, (Ueland FR, DeSimone CP, Seamon et al. Obstetrics & Gynecology 2011;117:1289-1297; Bristow RE, Smith A, Zhang Z et al. Gynecologic Oncology 2013;128:252-259) OVA1 plus clinical impression detected 96% of all malignancies vs. 75% for clinical impression alone. It subsequently reduced the number of malignancies missed from 25% to 4%, a reduction of 83%.
- For early-stage cancers specifically, 31% were missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%.
- Vermillion is currently developing a next-generation test, OVA2, which has an expected release in the second half of 2015.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company’s lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vermillion-receives-iso-13485-certification-for-companys-quality-management-system-300035611.html
SOURCE Vermillion, Inc.
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