LabCorp Launches New Assay for Screening Viruses in Blood Plasma

Burlington-based LabCorp has received approval from the U.S. Food and Drug Administration to market a diagnostic test that can detect four viruses in donated blood plasma used in making biologic therapies.

The UltraQual Multiplex PCR Assay screens simultaneously for the HCV, HIV-1, HIV-2 and HBV viruses in a single sample.

“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, Ph.D., chief scientific officer of LabCorp Diagnostics.

The assay will be offered exclusively by LabCorp’s National Genetics Institute (NGI) laboratory, which developed the test. NGI is a specialty testing group that helps the global plasma industry screen for infectious agents including HIV, the hepatitis A, B and C viruses, parvovirus B19 and West Nile virus.

LabCorp said UltraQual would be available to all biopharmaceutical companies involved in the manufacturing of plasma-derived therapies to enhance the safety and availability of those medicines. 
Already, one national company that collects donated blood plasma for use in making biologic medicines, has said it would begin using UltraQual. Charlotte-based Octapharma Plasma (OPI) operates 80 blood-donation centers and is a subsidiary of Octapharma AG, a maker of human therapeutic proteins headquartered in Lachen, Switzerland.

“This new assay provides OPI with enhanced sensitivity, specificity, turnaround time and overall value,” said Judy Smith, chief operating officer of OPI. It provides “a best-in-class solution to better advance our strategic goal of enhancing the collection of plasma used to create life-saving medicines for patients around the world.”

Biologics therapies make up more than one-third of the biopharmaceutical industry’s product pipeline. They include vaccines, blood and blood components, allergenics, gene therapies, somatic cells, tissues and recombinant proteins.

Earlier this year LabCorp announced that its Covance Drug Development business had formed a global immunology and immunotoxicology unit dedicated to biologic drug development. The company has also doubled its laboratory footprint in this sector.

LabCorp is a global life sciences company that provides diagnostics and drug-development services. It has about 60,000 employees worldwide and reported net revenues of over $10.2 billion in 2017.