Clinical Trials Commence for New HTLV Confirmatory Test

14 Dec 2011
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MP Biomedicals, LLC has begun a clinical trial for the U.S. regulatory approval of its MP Diagnostics™ HTLV Blot 2.4 assay. The assay is designed to test human serum and plasma for Human T-Cell Lymphotropic Virus (HTLV) infection in the transfusion and transplantation community.

HTLV is a retrovirus which infects predominantly T-lymphocytes in the human body. There are 2 types of HTLV, type I and type II. Type I HTLV is endemic in the Caribbean, Japan, South America, and parts of Africa. Type II HTLV is found among Native Americans. Although the vast majority of people infected with HTLV are asymptomatic carriers, HTLV infection is known to cause Adult T-cell leukaemia/lymphoma (ATLL), and HTLV-I-associated myelopathy (HAM) in some patients.

HTLV can be transmitted through unprotected sexual contact; from an infected mother to her baby by prolonged breast feeding; sharing of needles by drug users; and transfusion of infected donor blood.

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.”

MP Biomedicals initiated the clinical data collection phase of its clinical trial on the 5th December 2011, and expects this 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, anticipated to begin 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.

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Sonia Nicholas
Clinical Diagnostics Editor