LabCorp (NYSE: LH), a leading global life sciences company, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV for screening of donated blood plasma.
This innovative assay, which was developed and will be exclusively offered by its National Genetics Institute (NGI) laboratory, builds upon LabCorp’s rich history in the development and commercialization of novel diagnostic tests.
The UltraQual Multiplex PCR Assay enables the simultaneous and sensitive detection of four viral targets (HCV, HIV-1, HIV-2 and HBV) in a single sample. Coupled with NGI’s previously FDA-approved and exclusive process to greatly increase testing throughput, the new UltraQual Multiplex PCR Assay provides enhanced turnaround time and value to the rapidly growing biologics sector of the biopharmaceutical industry.
According to the FDA, biologics products include vaccines, blood and blood components, allergenics, gene therapies, somatic cells, tissues and recombinant proteins. Biologics therapies derived from plasma treat well-defined medical conditions, replacing missing or deficient proteins found in an individual’s plasma and allowing patients to lead healthier and more productive lives through the benefits of the therapy. 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 to enhance the safety and availability of these important medicines.
‘We are excited to receive FDA approval for the UltraQual Multiplex PCR Assay, as it demonstrates LabCorp’s continued commitment to delivering world-class diagnostic solutions that help to bring new medicines to patients faster, thereby improving health and improving lives,’ said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. ‘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.’
On March 9, 2018, LabCorp announced that its Covance Drug Development business formed a global immunology and immunotoxicology (I&I) unit dedicated to the specific needs of biologic drug development. The formation of this unit, along with Covance’s doubling of its I&I laboratory footprint and LabCorp Diagnostics’ expanding suite of biologic therapeutic drug monitoring tests, illustrate LabCorp’s expanding expertise and leadership in the development and commercialization of new services to support the rapidly growing biologics market.
Octapharma Plasma (OPI), a company that collects donated blood plasma for use in the creation of life-saving medicines, expressed early interest in using the UltraQual Multiplex PCR Assay.
‘OPI is looking forward to transitioning to NGI’s FDA-approved UltraQual Multiplex PCR Assay for our donor plasma screening programs,’ said Judy Smith, chief operating officer of OPI. ‘This new assay provides OPI with enhanced sensitivity, specificity, turnaround time, and overall value, providing 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.’
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