MP Biomedicals, a leading provider of life science reagents, fine chemicals and diagnostic products, announced today that it has received FDA approval on the MP Diagnostics HTLV (Human T-Cell Lymphotropic Virus) Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination.
This approval signifies the first ever FDA approved HTLV confirmatory assay in the US.
MP Biomedicals continues to be a leader in immunoblot confirmatory diagnostics with over 25 years of research and development in Immunoblot products. Immunoblot assays have stood the test of time, surpassing its competitors in delivering high-performance results. Many worldwide experts consider the MP Biomedicals immunoblot product line the benchmark in confirmatory diagnostics.
An important differentiator of the HTLV Blot 2.4 design is the incorporation of the patented GD21 recombinant envelope protein, recombinant proteins specific to HTLV-I and HTLV-II, and HTLV viral lysate. Sensitivity and specificity are greatly enhanced, providing laboratories with reliable results for both conformation and differentiation between HTLV-I and HTLV-II infections.
This information is crucial when counseling infected individuals, due to the different health implications of the two HTLV viral types.
"This marks the first FDA-approved infectious disease assay in the company’s product portfolio, and we plan to continue building on this milestone," said Milan Panic, Chairman and CEO. "Our focus on quality remains our top priority."
HTLV is a retrovirus which predominantly infects human T-lymphocytes. While the vast majority of people infected with HTLV are asymptomatic carriers, HTLV infection is known to cause Adult T-cell leukemia/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.