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Media Center Overview
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Talecris Biotherapeutics Becomes First Plasma Fractionator to Perform In-house HBV Screening Using FDA-Licensed Protocol
Talecris now approved for in-house testing of HIV, HCV, and HBV, further ensuring the safety of its plasma-derived biological therapies
RESEARCH TRIANGLE PARK, N.C. (May 26, 2005) – Building on a tradition of leadership in pathogen safety of biological products, Talecris Biotherapeutics has become the first plasma fractionator to use an FDA-licensed test to perform in-house nucleic acid testing (NAT) of hepatitis B (HBV) for source plasma. Moreover, Talecris also is now the first plasma fractionator conducting in-house testing on source plasma for human immunodeficiency virus (HIV), hepatitis C (HCV), and HBV using FDA-approved tests. This provides Talecris with even greater control in confirming the safety of its plasma donations, above and beyond the strict standards and protocols already in place for the screening and donation process.
Talecris collaborated with Roche Diagnostics to provide the necessary data to the FDA for consideration of the HBV NAT test. Roche's FDA-approved Cobas AmpliScreen HBV Test allows for the detection of HBV in whole blood, blood components, and source plasma. Concurrent with Roche's application to the FDA, Talecris submitted a supplement to its Biologics License Application (BLA) to include Roche's Cobas AmpliScreen HBV Test for in-house testing of human-source plasma.
The Cobas AmpliScreen HBV Test is on par with other testing protocols conducted by commercial laboratories. The testing allows for rapid identification and detection of specific HBV-infected donations, resulting in faster notification to all parties, potentially earlier treatment of the infected donor, and prevention of further donations by that donor. By receiving approval for conducting this testing in-house using the Cobas AmpliScreen HBV Test, Talecris can more directly ensure the integrity of the testing process and the resulting safety of its plasma products.
"Approval of this additional test is further demonstration of Talecris' commitment to provide the safest, most reliable products to our patients," said Larry Stern, Executive Chairman of Talecris Biotherapeutics. "We are pleased to be an industry leader when it comes to the testing and safety of our plasma, and we will continue to set the standard for our industry."
Douglas C. Lee, Ph.D., Director of Nucleic Acid Technologies (NAT), led the Talecris effort resulting in FDA approval of this new screening protocol. "NAT testing is the state-of-the-art for pathogen detection. Through the use of Roche's innovative Cobas AmpliScreen Tests, Talecris now screens plasma for HIV, HCV, and HBV in our own laboratories using a state-of-the-art NAT method."
Contact:
Lacy McMahon
Tel.: 919.316.6316, Fax: 919.316.6673
E-mail: lacy.mcmahon@talecris.com
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,000 talented people worldwide.
To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.
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