Vermillion Announces CE Mark for Overa®, the Next Generation OVA1® Test

AUSTIN, Texas, Oct. 26, 2015 /PRNewswire/ -- Vermillion, Inc. VRML, a bio-analytical solutions company focused on gynecologic disease, today announced registration of the CE mark for and clearance to market in the European Union the next generation of Vermillion's OVA1^® test for detecting risk of malignancy for ovarian cancer. The next-generation test, previously referred to as OVA2, has been trademarked "Overa." Results of validation testing for Overa were made public with the presentation of two posters at the 2015 American Society for Clinical Oncology's Annual Meeting in May.

Key findings for Overa compared to OVA1 were as follows:

• Significant improvement in specificity at 69%, a 28% improvement versus OVA1
• This improvement translated into 33% fewer benign positives compared with OVA1
• Positive predictive value (PPV) increased from 31% (OVA1) to 40% (Overa), an improvement of 29% in a head to head comparison with the same patient population, along with a 20% improvement in overall clinical accuracy
• Maintenance of the same high sensitivity as OVA1 at approximately 91%
• Negative predictive value (NPV) was also equivalent at 97%

The indications for use for Overa are as a qualitative serum test that combines the results of five immunoassays into a single numeric result. By design, Overa uses a single cutoff score of 5 (on a scale of 10) for risk of malignancy, regardless of menopausal status, increasing ease of use and simplifying interpretation compared to OVA1. Overa is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of malignancy as part of the preoperative evaluation. 

"We are pleased with Overa's clinical performance and are excited to announce its clearance for marketing in the European Union," said Valerie Palmieri, President and CEO of Vermillion. "Coupling an early risk assessment test for ovarian cancer with a global distribution platform, the Roche cobas^® 6000, should make for significant strides in early detection of ovarian cancer worldwide. We are actively identifying global partnerships and are confident that general practitioners in the European Union will embrace Overa's industry-leading, clinically validated technology. This technology can be used to detect all stages of ovarian cancer, at all patient ages, for all ovarian cancer types. Our ultimate goal is stage shift ovarian cancer detection, from the majority being diagnosed at stage 3 and 4 with less than 50% survival, to Stage 1 and 2, where 80 to 90% of patients survive. This is a historic moment for the company and women worldwide."

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 gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company's lead diagnostics in the United States, OVA1, and in the European Union, Overa, are blood tests for pre-surgical assessment of ovarian tumors for malignancy, each using an innovative algorithmic approach. Overa and OVA1, which was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, represent a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.

About Overa

• Overa is a simple blood test to help physicians assess the likelihood of ovarian cancer in connection with a suspicious pelvic mass. It is not a screening test; rather, Overa is to be used together with a physician's overall clinical assessment to help guide pre-surgical risk assessment and decision-making
• Overa measures the levels of five proteins found in the blood and then uses a proprietary software called OvaCalc^® to calculate a single score. A woman's risk of cancer is measured by using a 0-10 scale versus a single cut-off point of ³5
• An elevated Overa test result may help the physician determine if the woman should be referred to a gynecologic oncologist. Studies have shown that women with ovarian malignancies can experience better outcomes when they are operated on by a gynecologic oncologist. Overa is currently under review by the United States Food and Drug Administration.

Forward-Looking Statements

This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including with respect to the effects of a global distribution platform and Vermillion's expansion into international markets.  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 factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ from those projected in such forward-looking statements include but are not limited to: (1) Vermillion's ability to commercialize Overa outside the United States; (2) Vermillion's ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; (3) Vermillion's ability to compete successfully; (4) Vermillion's ability to obtain any regulatory approval for its future diagnostic products; (5) Vermillion's or its suppliers' ability to comply with FDA requirements for production, marketing and post market monitoring of its products; (6) additional costs that may be required to improve Vermillion's manufacturing operations; (7) Vermillion's ability to maintain sufficient or acceptable supplies of immunoassay kits from its suppliers; (8) Vermillion's ability to generate sufficient demand for ASPiRA Labs' services to cover its operating costs; (9) Vermillion's ability to comply with the additional laws and regulations that apply to it in connection with the operation of ASPiRA Labs; (10) Vermillion's ability to comply with FDA regulations that relate to its products and to obtain any FDA clearance or approval required to develop and perform laboratory-developed tests; and (11) other factors that are described in Vermillion's Form 10-Q for the quarter ended June 30, 2015 filed with the Securities and Exchange Commission (the "SEC"). 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.

This release should be read in conjunction with the consolidated financial statements and notes thereto included in Vermillion's most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.

Cobas^® is a registered trademark of Roche Diagnostics.

Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com

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SOURCE Vermillion, Inc.