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Ohio State University shows that diagnostic test may predict TTP relapse

Vermillion : 25 April, 2008  (Company News)
An Ohio State University (OSU) clinical study has 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 characterised by frequent recurrences, with approximately half of all patients experiencing relapses,' said Haifeng M Wu, MD, 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 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 (less than 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 utilised not only for diagnosing TTP, but also for surveillance of TTP patients during clinical remission,' said Gail Page, president and chief executive officer of Vermillion. 'Vermillion is dedicated to the development and commercialisation 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.
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