Market Overview

QualTex Laboratories Implements New Zika Testing Guidance from U.S. Food and Drug Administration

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San Antonio, Aug. 22, 2018 (GLOBE NEWSWIRE) -- QualTex Laboratories is up and running with new guidance for testing blood donations for the Zika virus, just weeks after the Food and Drug Administration issued revised recommendations for blood centers.

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In July, the FDA distributed a Guidance for Industry permitting the use of "minipool" testing for Zika, in which samples from a small group of donors are combined and tested for the presence of Zika virus antibodies. Since Zika testing began in 2016, all donations had been required to be tested individually.

The new minipool Zika method began at QualTex Laboratories facilities in San Antonio and Norcross, Georgia, on Aug. 16. QualTex performs blood testing for the South Texas Blood & Tissue Center (STBTC), as well as blood and plasma centers throughout the United States.

"Our partnership with Roche gave us a more-rapid implementation of the minipool Zika testing," said Ward Carter, chief operating officer of QualTex Laboratories, which along with STBTC is a subsidiary of BioBridge Global. "We had prepared for this change and wanted to be an early adopter of the minipool methodology."

QualTex was one of the first testing centers in the United States to make the Zika test available, working with the pharmaceutical giant Roche on development of the assay in 2016. The FDA recommended testing all blood and blood products for the presence of the Zika virus in July 2016.

The change will result in lower costs for blood centers, Carter noted, since running in a minipool format has a lower overall cost than the individual method.

The FDA's revised recommendations noted that if there is a positive test for the Zika virus, or if the Centers for Disease Control or other health agencies determine there is a high risk for Zika virus transmission in a certain area, then all donations will need to be tested individually.

Positive tests have been rare since the FDA released its initial guidelines in2016. QualTex has not had a confirmed positive test, and a study published in the New England Journal of Medicine showed the nation's largest blood collection organization had just eight positive tests out of more than 4 million donations in the first 15 months of Zika testing.

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About QualTex Laboratories: QualTex Laboratories is a nonprofit affiliate of BioBridge Global that provides state-of-the-art biologic testing services on whole blood, plasma and human cells, tissue, and cellular- and tissue-based products (HCT/P) for its global biotechnology and biopharmaceutical customers. It is one of the nation's largest nonprofit testing laboratories and has locations in Texas and Georgia. Visit us at qualtexlabs.org.

About BioBridge Global: BioBridge Global (BBG) is a San Antonio, Texas-based 501(c)(3) nonprofit corporation supporting regenerative medicine with diverse products and services, through its operating subsidiaries – the South Texas Blood & Tissue Center, QualTex Laboratories and GenCure – and supported by the community through The Blood & Tissue Center Foundation.  BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients both domestically and abroad.  BBG is committed to saving and enhancing lives through the healing power of human cells.  It fulfills part of this mission by supporting groundbreaking research, addressing unmet clinical needs and enabling the development and commercialization of novel biotechnology products.

 

 

Mary Uhlig
BioBridge Global
210-731-5519
mary.uhlig@biobridgeglobal.org

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