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FDA Approves LabCorp Multiplex PCR Assay for HCV, HIV, HBV

NEW YORK (GenomeWeb) – Laboratory Corporation of America announced today it has received US Food and Drug Administration approval for the UltraQual Multiplex PCR Assay for hepatitis C, HIV-1, HIV-2 and hepatitis B for the screening of donated blood plasma.

The new test, which is offered exclusively from LabCorp's National Genetics Institute, enables the simultaneous detection of the four viral targets in a single sample. Coupled with NGI's previously FDA-approved process to increase testing throughput, the new UltraQual Multiplex PCR Assay provides enhanced turnaround time and value to the biologics sector of the biopharmaceutical industry.

Biologics therapies derived from plasma treat well-defined medical conditions, replacing missing or deficient proteins found in an individual's plasma. Biologics therapies make up more than one-third of the biopharmaceutical industry pipeline, and this new test is available to all biopharmaceutical companies involved in the manufacturing of plasma-derived therapies, LabCorp said. According to the FDA, biologics products include vaccines, blood and blood components, allergenics, gene therapies, somatic cells, tissues, and recombinant proteins.

"This next-generation technology offers the international biopharmaceutical industry a differentiated solution to improve plasma donor collection programs and the manufacturing of plasma protein therapies for a variety of life-threatening conditions including bleeding, immune, cardio/pulmonary, and neurological disorders," said Marcia Eisenberg, chief scientific officer of LabCorp Diagnostics.

In March LabCorp announced that its Covance Drug Development business formed a global immunology and immunotoxicology unit dedicated to the specific needs of biologic drug development. The new unit, Covance's doubling of its I&I laboratory footprint, and LabCorp Diagnostics' expanding suite of biologic therapeutic drug monitoring tests are part of the company's efforts to support the rapidly growing biologics market.