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» MP Biomedicals Submits Biologic License Application (BLA) for FDA Approval of HTLV Confirmatory Test
MP Biomedicals Submits Biologic License Application (BLA) for FDA Approval of HTLV Confirmatory Test
|SANTA ANA, Calif. - Monday, January 28th 2013 [ME NewsWire]|
(BUSINESS WIRE)-- MP Biomedicals, LLC announced today that it has submitted a BLA for FDA approval of the MP Diagnostics HTLV Blot 2.4, a Western blot for confirmatory testing and viral typing of blood donors and patients.
Additionally, MP Biomedicals plans to initiate an open IND study in February, which will allow for investigational use (IUO) of the assay on donor and patient samples while the product is under FDA evaluation. The American Red Cross is among the study participants. U.S. labs interested in participating may contact Karen Luthart for more information (see above).
"The HTLV Blot 2.4 represents a significant milestone for our company and it will be the first licensed confirmatory test for donor notification and counseling of HTLV infections in the U.S.,” said Milan Panic, Founder and Chief Executive Officer of MP Biomedicals. The assay is currently CE Marked and registered as a diagnostic device in 10 countries around the world.
An important aspect of the HTLV Blot 2.4 is the incorporation of unique recombinant proteins from the envelopes of both HTLV-I and HTLV-II viruses. This feature greatly enhances sensitivity and specificity, providing clinical and donor labs with reliable results for both confirmation and differentiation between HTLV-I and HTLV-II infections. This information is necessary when counseling infected donors, because of the different health implications of the two HTLV viral types.
HTLV is a retrovirus which infects predominantly T-lymphocytes in the human body. HTLV Type I is endemic in the Caribbean, Japan, South America, and parts of Africa. HTLV Type II is found among Native Americans. Although the vast majority of infected individuals 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.
About MP Biomedicals LLC
MP Biomedicals is a worldwide corporation headquartered in Southern California, with ISO-certified and FDA-approved manufacturing and distribution facilities throughout the globe. MP Biomedicals manufactures and sells more than 55,000 products and is one of the only companies in the industry to offer a comprehensive line of life science, fine chemical and diagnostic products. MP Biomedicals has a long-standing history of marketing high-quality diagnostic products, including Western blots, ELISAs, rapid tests and analyzer solutions. A vast network of global distributors, satellite facilities and offices throughout Europe, Asia, Australia and the Americas ensures product delivery whenever and wherever needed.
For more information, please visit www.mpbio.com.
MP Biomedicals, LLC
Karen Luthart, +1 949-269-5054
Product Manager, Infectious Disease
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