AUSTIN, Texas, February 11, 2016 — Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, today announced the formation of the Steering Committee for its Pelvic Mass Registry.
Pelvic masses can present physicians and healthcare professionals with difficulties in both diagnosis and management. Once pregnancy is ruled out, pelvic masses may include cancers of the uterus, fallopian tubes and ovaries, advanced endometriosis, benign ovarian tumors and gastrointestinal and urinary tract masses.
The Registry will aim to enroll 3,000 women and enable unprecedented research and development of multivariate diagnostics and “big data” algorithms for the early detection, differential diagnosis and treatment of these conditions. Through monitoring of women with suspicious or symptomatic pelvic masses, Vermillion expects to identify diagnostic analytes, including measurement of DNA, RNA and proteins, along with external diagnostics such as imaging (ultrasound, CT scan, MRI) and clinical factors which can be used to provide early detection, diagnosis, prognosis and monitoring of these gynecologic diseases which affect more than one million women in the United States, annually¹.
The Registry Steering Committee will advise Vermillion on scientific and clinical strategy and oversee the study design and publication. Members announced today include leading national and international experts on ovarian cancer, endometriosis and public health policy:
|Judith Wolf, MD
|Chief Medical Officer, Vermillion Inc. Austin, TX|
|Donald Munroe, PhD
|Chief Scientific Officer, Vermillion Inc. Austin, TX|
|Jubilee Brown, MD
|Professor, Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX|
|Terri Cornelison, MD, PhD||Associate Director for Clinical Research, NCI Office of Research on Women’s Health, Bethesda, MD|
|Calaneet Balas||Chief Executive Officer, Ovarian Cancer National Alliance, Washington DC|
|David Miller, MD||Gynecologic Oncologist, University of Texas Southwestern, Dallas, TX|
|Devansu Tewari, MD||Gynecologic Oncologist, Southern California Permanente Medical Group, Irvine, CA|
This Pelvic Mass Registry results from a unique public-private partnership. Vermillion has been approved for a $7.5 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the registry, subject to satisfactory completion of a grant contract between Vermillion and CPRIT. Receipt of the grant award is subject to execution of a grant contract on terms acceptable to both Vermillion and CPRIT and may include such terms as payment of future product royalties to CPRIT by Vermillion.
Vermillion’s Chief Medical Officer and Registry co-primary investigator, Dr. Judith Wolf, stated: “Today’s Registry Steering Committee kickoff completes the first step of an ambitious plan to improve early detection and differential diagnosis of pelvic mass diseases requiring surgery. By sifting patient data and clinical samples for innovative diagnostic patterns, we hope to re-engineer the methods physicians use to sort and treat these conditions. Improved detection, diagnostic accuracy and timely access to specialist care benefits patients, physicians and healthcare systems alike.”
Valerie Palmieri, Vermillion’s President and CEO, added, “Vermillion’s Pelvic Mass Registry represents a major strategic initiative for the development of “big data” algorithms to fight the war against ovarian cancer. In addition to malignancies, several other major debilitating benign conditions, such as endometriosis, which is equally difficult to diagnose and affects ~14M women per year and costs healthcare systems billions each year, will be incorporated into this one of a kind study. We are grateful for the commitment and support of the dedicated physicians, gynecologic oncology leaders and women’s health advocates of our Registry Steering Committee.”
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 in the United States, OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach and is available through Vermillion’s wholly owned subsidiary, ASPiRA LABS. OVA1, which was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, represents a new class of software-enabled Liquid Biopsy diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve a significant number of risks and uncertainties, including with respect to the Pelvic Mass Registry and its uses. 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 those factors that are described in Vermillion’s Form 10-Q for the quarter ended September 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.
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1. Myers ER, Bastian LA, Havrilesky LJ, et al. Agency for Healthcare Research and Quality (US); 2006 Feb. (Evidence Reports/Technology Assessments, No. 130.)