AUSTIN, Texas, July 13, 2015 /PRNewswire/ — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today that its wholly owned subsidiary, ASPiRA Labs, has received its clinical laboratory permit for the state of New York. ASPiRA Labs has now completed the process of obtaining licensure in all of the states that require licenses to process OVA1 specimens, a process that was begun one year ago with the establishment of the diagnostic services laboratory. This New York state permit should significantly speed the conversion of all OVA1 specimen processing from Quest Diagnostics, Inc. to ASPiRA Labs, as described in the March 17th, 2015 announcement of the new commercial agreement between the companies.
Valerie Palmieri, Vermillion’s President and CEO, stated, “With the issuing of the New York state permit, ASPiRA Labs can now be responsible for all OVA1 processing in the US, which was a major goal in our new commercial agreement with Quest. Quest customers, our regional lab partners, and direct physician customers will be served by ASPiRA Labs on a national basis, while receiving a consistent high quality, personalized customer experience.”
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 gynecologic health outcomes for women. 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.
About ASPiRA Labs
ASPiRA Labs is a diagnostic services laboratory founded by Vermillion, Inc., a leader in women’s health diagnostics. The laboratory’s goal is to provide high quality, innovative testing and bio-analytics for women to help address unmet women’s health needs. ASPiRA Labs’ specialized services are grounded in evidence-based medicine, while providing access to novel biomarker diagnostic tools designed to help health care professionals offer the most precise diagnoses and treatment guidance for their patients. To learn more about ASPiRA Labs, visit www.aspiralab.com.
- 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, 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%
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, regarding the conversion of OVA1 processing from Quest to ASPiRA Labs. These statements involve significant risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of other factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including those that are described in Vermillion’s Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
LifeSci Advisors LLC
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SOURCE Vermillion, Inc.