Life sciences firm LabCorp has launched the new UltraQual Multiplex PCR Assay in the US for the detection of viruses in donated blood plasma, following the US Food and Drug Administration (FDA) approval.
Developed by the National Genetics Institute (NGI) laboratory, the test is designed to simultaneously identify hepatitis C virus (HCV), human immunodeficiency virus (HIV) 1 and 2, and hepatitis B virus (HBV) in a single sample.
When combined with NGI’s process to enhance testing throughput, UltraQual is said to offer improved turnaround time and value.
The assay is intended to aid biopharmaceutical companies that manufacture plasma-derived therapies in assessing the safety and availability of their medicines.
These plasma-derived therapies, known as biologics, replace missing or deficient proteins in a patient’s plasma to treat various well-defined medical conditions.
LabCorp Diagnostics chief scientific officer Marcia Eisenberg said: “This next-generation technology offers the international biopharmaceutical industry a differentiated solution to improve plasma donor collection programmes and the manufacturing of plasma protein therapies for a variety of life-threatening conditions including bleeding, immune, cardio/pulmonary and neurological disorders.”
In March this year, LabCorp’s Covance Drug Development unit launched an immunology and immunotoxicology (I&I) unit focussed on catering to global biologic drug development needs.
The I&I unit, Covance’s expanded laboratory footprint, and LabCorp Diagnostics’ boost to its biologic therapeutic drug monitoring tests range are expected to support the company’s strategy to develop and commercialise new services for biologics market.