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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.
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