Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, announced a new commercialization and services agreement with Quest Diagnostics, the world's leading provider of diagnostic information services, related to Vermillion's OVA1 ovarian cancer test.

OVA1 was the first test cleared by the FDA for aiding in the pre-surgical evaluation of an ovarian mass for cancer. Since launch in 2010, Quest Diagnostics has been the exclusive National laboratory provider offering this test.

Under the new agreement, Vermillion's wholly-owned subsidiary, ASPiRA Labs, will begin to offer OVA1 testing to Quest customers. Quest Diagnostics expects to transfer all OVA1 testing service to ASPiRA Labs starting with 39 states this year, while providing the current logistics support to transport specimens from its clients to ASPiRA Labs for testing. Quest will continue to offer OVA1 services through its own OVA1 performing lab in the remaining 11 states until ASPiRA Labs has the required state approvals to provide services.

Quest will receive an undisclosed sum and fees for logistic support services provided to Vermillion under the new agreement. Additional terms were not disclosed.

In addition, the two parties have also reached a settlement agreement under which all claims related to prior strategic alliance and loan agreements are dismissed and terminated.

Valerie Palmieri, CEO of Vermillion/ASPiRA, Inc. noted, "We are pleased that we are taking steps to offer OVA1 testing through ASPiRA on behalf of Quest Diagnostics clients."

About Pelvic Masses: 500,000 – 1 million women experience pelvic 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 gynecologic cancers.

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.

Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for women with gynecologic disease.  

ASPiRA Labs is an innovative diagnostic services laboratory founded by Vermillion, Inc., a leader in women's health diagnostics.