AUSTIN, Texas, April 20, 2016 — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced the publication of the first clinical utility data demonstrating that identification of high-risk patients using OVA1 prior to surgery resulted in referral of nearly all patients who had primary ovarian malignancies to gynecologic oncologists. The study, titled “The clinical utility of an elevated-risk multivariate index assay score measured by pre-surgical involvement of gynecologic oncologists in the management of ovarian cancer,” to be published in the peer-reviewed journal Current Medical Research & Opinion (CMRO), is now available online as a pre-print (DOI: 10.1080/03007995.2016.1176014).
Dr. Ramez Eskander, first author and faculty member at UC Irvine’s Division of Gynecologic Oncology in Orange, California, stated “This study documents the first peer-reviewed evidence on how OVA1 results affect real-world patient care. Approximately 80% of patients with a high-risk OVA1 result were referred to or consulted with a gynecologic oncologist, providing an opportunity for critical pre-surgical input to patient care. Even more important, 100% specialist involvement was found in the 65 primary ovarian cancer cases, with 94% of these surgeries being performed by a gynecologic oncologist.”
Vermillion’s Chief Medical Officer and co-author of the study, Dr. Judith Wolf, added, “An important opportunity to improve survival is lost when initial ovarian cancer surgery and treatment is not performed by a trained specialist. Unfortunately, many women fail to receive this care today, in part due to less sensitive and more subjective methods commonly used to assess ovarian cancer risk prior to surgery. Our clinical utility study of high-risk OVA1 results represents an important step in providing women with highly effective access to specialist care for ovarian cancer.”
The study surveyed physicians with frequent OVA1 use, and identified 122 patients who underwent surgery for a pelvic mass after a high-risk OVA1 score was reported. Of these, 65 had a primary ovarian malignancy, while the remainder were benign or had a metastatic cancer of non-ovarian origin. Pre-surgical involvement of a gynecologic oncologist was documented, including referral, consultation or availability on stand-by; and the specialty of the surgeon who performed the adnexal surgery was also recorded. Of the 4 patients whose surgery was not performed by a gynecologic oncologist, 2 required re-operation for complete staging by a gynecologic oncologist. In comparison, none of the 61 ovarian cancers that were operated on by a gynecologic oncologist required restaging. According to the National Academy of Medicine’s 2016 report, Ovarian Cancers: Evolving Paradigms in Research and Care, re-operations are common after non-specialists operate on ovarian cancer, and may result in delayed treatment, higher costs and inferior outcomes compared with ‘first time right’ surgery by a gynecologic oncologist.
Clinical utility of low-risk OVA1 results may be the subject of a future publication.
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, discovers, develops, and delivers innovative diagnostic and technology tools that help women conquer serious diseases. The company’s initial in vitro diagnostic test, OVA1®, was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016 Vermillion received FDA clearance for Overa™, a second generation OVA1 with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
About OVA1® and Overa™
- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and as a result provide more effective referral of high risk patients to a specialist (gynecologic oncologist) for surgical treatment
- 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 (CI). As a result, false negatives were reduced from 25% for CI, to 4% with OVA1 plus CI, a reduction of 83%
- In a study focused on early-stage cancer detection, 31% of cases were missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%
- Overa, cleared by FDA on March 18, 2016, measures the levels of five proteins found in the blood and then uses a second-generation OvaCalc® algorithm to stratify risk. A woman’s risk of cancer is measured by using a 0-10 scale with a single cut-off point of 5 eliminating the ambiguity in determining menopausal status. A high Overa score is not a diagnosis of cancer, rather it indicates an increased risk of malignancy when used as intended.
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant a number of risks and uncertainties, including with respect to future publications. 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 factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2015 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.
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