MP Biomedicals LLC announced today that it has received approval of its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to start pivotal clinical trials in the USA with the MP Diagnostics™ HTLV-I/II ELISA 4.0 and HTLV Blot.2.4. Studies will be conducted within the American Red Cross, the California Department of Public Health, and LABS, Inc. The company is working closely with the principal investigator of the American Red Cross sites, Dr. Susan Stramer, Executive Scientific Officer.
"This represents a significant milestone for our company and we look forward to working with Dr. Stramer and our other collaborators in this important study. With only one FDA licensed test available to Blood Banks today, we believe the adequacy of the nation's blood supply may be further enhanced with the addition of a second licensed screening platform, and the first ever licensed confirmatory test," said Milan Panic, Founder and Chief Executive Officer of MP Biomedicals, LLC.
The purpose of the clinical trial is to qualify both investigational devices for the detection and confirmation of antibodies to HTLV-I and HTLV-II viruses in blood. When all FDA study requirements are achieved, MP will submit a Biological License Application (BLA) to the FDA to permit commercial sales of the products for their intended use.
Screening for antibodies to HTLV-I/II is required by the FDA for all blood donations.
The specific goals of the US trials will be to evaluate:
The MP Diagnostics™ HTLV-I/II ELISA 4.0 as an enzyme-linked immunosorbent assay intended for the detection of antibodies to Human T-cell Lymphotropic Virus Type I (HTLV-I) and Type II (HTLV-II). The HTLV-I/II ELISA 4.0 will be qualified to screen individual donors, including volunteers of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. The ELISA will be qualified to be used as part of a blood donor screening algorithm where it is used as a second EIA following the generation of repeat reactive donor samples on a different assay using a different platform. It will also be qualified for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (post-asystolic) donors.
The MP Diagnostics™ HTLV Blot 2.4 will be evaluated as a qualitative enzyme immunoassay for the detection of antibodies to HTLV-I and HTLV-II in human serum or plasma. It will be qualified as a more specific supplemental test used on human serum or plasma specimens found repeatedly reactive using screening procedures like the ELISA when used as the primary screen, or as a more specific test for samples testing repeatedly reactive in a dual test algorithm.