FREMONT, Calif., April 24 /PRNewswire-FirstCall/ -- Vermillion, Inc. (Nasdaq: VRML) today reported findings from an Ohio State University (OSU) clinical study that indicated that a surface-enhanced laser desorption/ionization time of flight (SELDI-TOF)-based thrombotic thrombocytopenic purpura (TTP) diagnostic test could be used to help estimate the risk of TTP relapses during clinical remission. OSU currently offers the TTP test as a laboratory developed test, based on an exclusive licensing agreement with Vermillion, and for which Vermillion sells OSU supplies and laboratory reagents.
The data -- published recently in the online edition of the British Journal of Haematology -- indicate that use of the test may provide a novel screening strategy to identify patients who may benefit from prophylactic treatment to help prevent relapse of this serious blood disorder. TTP is caused by a deficient activity of the enzyme ADAMTS13, which leads to platelet clumping, red blood cell destruction, and, in serious cases, to neurological abnormalities and renal failure.
"TTP is a life-threatening disease that affects thousands of people each year. The disease is characterized by frequent recurrences, with approximately half of all patients experiencing relapses," said Haifeng M. Wu, M.D., lead investigator of the study and Assistant Professor of Pathology and Medicine and Director of the Clinical Coagulation Laboratory at OSU Medical Center. "The SELDI-TOF technology was instrumental in improving sensitivity for extremely low levels of ADAMTS13, which may be used to help identify patients who could be candidates for prophylactic treatment based upon their increased risk for relapse of this devastating blood disorder."
The study showed that extremely low levels of ADAMTS13 activity are associated with increased risk of TTP relapses during remission. A key characteristic of the assay is that it is more sensitive than other assays and exhibits improved accuracy at low (<2.5 percent) ADAMTS13 activity.
"These study findings represent an important milestone, as they demonstrate that the test -- which our Company co-developed with the OSU Research Foundation -- could be utilized not only for diagnosing TTP, but also for surveillance of TTP patients during clinical remission," said Gail Page, President and CEO of Vermillion. "Vermillion is dedicated to the development and commercialization of molecular diagnostic tests to help physicians and their patients diagnose and appropriately treat diseases, particularly cardiovascular disease and cancer. The TTP test is an example of how our technology has led to significant new means to properly diagnose and screen patients with this serious disorder."
Using the SELDI-TOF technology, the TTP test could help physicians make the correct diagnosis, initiate timely treatment, and evaluate response to therapy. These new study findings suggest that the test can additionally be used to help screen for the risk of relapse in patients with TTP.
About the Study
ADAMTS13 activity and ADAMTS13 antibody (IgG) were evaluated in 157 clinical samples collected prospectively during periods of clinical remission from 24 TTP patients enrolled in other prospective studies at OSU. These patients received regular follow-up for an average of 23 months, with serial samples taken at 3-month intervals. Nine episodes of TTP relapse occurred among six patients. Logistic regression modeling was used to define the relationship between ADAMTS13 activity levels and the probability of TTP relapses.
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 patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women's health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at http://www.vermillion.com.
Forward Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward- looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that 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. There are no guarantees that Vermillion will succeed in its efforts to commercialize TTP diagnostic products in 2008 or during any other period of time. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize TTP diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop TTP diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its TTP diagnostic products; (5) uncertainty of market acceptance of its TTP diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payors such as private insurance companies and government insurance plans; and (6) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
SOURCE Vermillion, Inc.