MP Biomedicals Initiates U.S. Clinical Trials for its HTLV Blot 2.4 Confirmatory Test
MP Biomedicals, LLC announced today that the company has begun a clinical trial for the U.S. regulatory approval of MP Diagnostics™ HTLV Blot 2.4 for use in testing serum and plasma in the transfusion and transplantation community. December 05, 2011 the company initiated the clinical data collection phase of the clinical trial, estimated to be completed within 4 - 6 weeks. The HTLV Blot 2.4 trial is the first of the two U.S. clinical trials the company is sponsoring, working in collaboration with the American Red Cross and Labs Inc., Missouri. Subsequent to the completion of the blot trial, the company will initiate the second trial for the MP Diagnostics™ HTLV-I/II ELISA 4.1 System, slated for early 2012. "The HTLV Blot 2.4 represents a significant milestone for our company and it will be the first licensed confirmatory test to help donor notification and counseling of HTLV infections in the U.S," said Milan Panic, Founder and Chief Executive Officer of MP Biomedicals. Both assays are currently CE Marked and registered as diagnostics devices in 10 countries around the world. Go to www.mpbio.com/HTLV for more information about HTLV.
"The American Red Cross is pleased to be an investigator in the MP Biomedical clinical evaluation of their investigational HTLV-I/II western blot assay. We look forward to the outcome of the study and are hopeful that this study will lead to the first FDA licensed confirmatory/supplemental test for HTLV-I/II antibodies." said Dr. Susan Stramer, Executive Scientific Officer of the American Red Cross and the principal investigator for MP Biomedicals.
The market withdrawal of the Abbott EIA kit in 2009 had left the nation's blood supply at risk of having only one approved HTLV-I/II test commercially available for donor screening. Data from the Red Cross suggest that on more than seven million donors, approximately 65 percent of repeatedly reactive samples, will not repeat with a second screening assay of a different type. With only one approved assay, it has caused a significant impact on the dual enzyme immunoassay (EIA) approach for deferral and notification of anti-HTLV-I/II EIA reactive donors (AABB bulletin #99-9). Donor samples testing repeatedly reactive by a second licensed EIA screening test are further tested by a supplemental assay i.e. a western blot to confirm and differentiate between anti-HTLV Type-I and Type-II infections or both. Donor counseling will be based on the results of such supplemental tests when a licensed supplemental test becomes available.
At the 2011 AABB in San Diego, CA, Edward L. Murphy, MD, MPH, professor at UCSF and senior investigator of Blood Systems Research Institute, said "We found an overall HTLV (combining HTLV-I and HTLV-II) prevalence of 21.8 per 100,000 among U.S. first-time blood donors during the years 2000 - 2009. With 3.2 million first-time donors annually (data from US Blood utilization survey), US blood banks therefore detect almost 700 HTLV infections per year which require counseling and medical follow-up. There is an urgent need for additional licensed blood tests for HTLV-I and HTLV-II, including screening enzyme immunoassays, and supplemental tests capable of confirming infection and differentiating HTLV-I from HTLV-II. This information is important in counseling infected donors because of the different health implications of the two HTLV types."
A lot of interest has been expressed in the transplant community for the much anticipated HTLV assays. "There are no FDA approved HTLV-I/II confirmatory tests in the United States. As we suggested in our earlier publication (Transplantation 82:1210;2006) testing for HTLV-I/II in low prevalence population without confirmatory tests results in loss of donors and unnecessary anxiety among those who tested positive using the EIA test only. The MP Bio's planned FDA application for their HTLV-I/II Western Blot is long awaited news for all laboratories screening US blood and tissue donors for anti-HTLV-I/II antibodies," remarked Marek J. Nowicki, Ph.D., scientific director at the Mendez National Institute of Transplantation, Los Angeles.
MP Biomedicals is a global entity that manufactures, markets, and distributes diagnostic kits for the clinical and research markets, fine chemicals for the industrial market, and a broad range of products for the life science market. The company has been in business since 1960.