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LABS Inc. Innovates, Expands Rapid Testing Portfolio to Better Serve Clientele Producing Complex Biologic Products  
10/16/2012 10:24:24 AM

CENTENNIAL, Colo., Oct. 15, 2012 /PRNewswire/ -- LABS, Inc., a global, full-service testing laboratory with more than 30 years of expertise in regulated testing for human organs, cells, tissues and implantable biologic products and devices, today announced the launch of two new laboratory tests suitable for screening complex biologic products. A new rapid microbial screening assay will allow LABS to determine the presence of microbial contamination within a biologic sample several days before the traditional culture methods. Additionally, new flow cytometry quality control panels allow LABS to determine the identity and purity of mesenchymal stem cell (MSC) products.

"We are very excited to launch these two new assays, which will give our clients close to real-time results on the quality and composition of their complex biologic products," said Chad Ronholdt, Vice President Strategic of Development at LABS, Inc. "Our research and development team is committed to developing and launching innovative rapid biologic services, which are propelling LABS to the forefront of the regulated testing market for complex biologics."

LABS' new cutting-edge testing solutions launch this month:

  • qPCR rapid pathogen screening: Cells and tissues used for live-cell biologic products must often be processed before microbiology results are completed, which means that the cell product is at a higher risk of discard due to a positive microbial culture post-processing. In an effort to deliver the industry new tools to guide cell and tissue processing decisions, LABS developed this proprietary Quantitative Polymerase Chain Reaction (qPCR) method to rule out presence of site-specific pathogenic microorganisms within 24-72 hours of receipt of sample, compared to the traditional 5-7 day culture periods. (qPCR is a biochemical technology utilized to amplify a single or few copies of a piece of DNA, generating thousands to millions of copies of a particular DNA sequence.) Additionally, the sensitivity and performance of this test are comparable to the more time-consuming culture screening method.
  • Mesenchymal stem cell flow cytometry quality control panels: Specially designed for mesenchymal stem cell (MSC) products, LABS has developed standardized quality control (QC) panels for products derived from: adipose, stromal vascular fraction, bone marrow and cord blood sources. Flow cytometry provides a high throughput, rapid, reproducible and sensitive way to evaluate the identity and purity of viable complex biologic products.

This new suite of tests also gives LABS clients the ability to choose from a list of more than 20 different cell markers to create a customized cellular characterization panel for cell-based biologic products. With any of these markers, the client will receive a report that contains at minimum: viability, total cell count, live/dead ratio as well as cell specific marker ratios.

"We anticipate these new testing solutions will delight clients by saving them both time and money," said Elizabeth Hearty, Chief Executive Officer of LABS, Inc. "We are proud to be a leader in developing and implementing cutting-edge testing solutions to meet the rapidly evolving biologic landscape, particularly for industries like biopharmaceuticals, cellular therapies, regenerative medicine and tissue engineering products."

About LABS, Inc.
LABS, Inc. is a global, full-service testing laboratory with more than 30 years of expertise in regulated testing for human organs, cells, tissues and implantable biologic products and devices. LABS provides an intimate customer service experience, which results in personalized laboratory solutions for clients in any stage of the product development lifecycle: donor eligibility, R&D, processing and validation and final lot release.

LABS has an established and trusted record of personalized service, compliance and integrity. The Company serves a variety of industries that are focused on advancing and understanding biologic-based products.

The company is headquartered in Centennial, CO with satellite facilities in St. Louis, MO and Philadelphia, PA. LABS receives sample shipments from across the globe and performs testing for 10 nations outside of the U.S.: Australia (TGA certified), Canada, Germany, Italy, Japan, Singapore, South Korea, Sweden, Switzerland and the United Kingdom. To learn more, visit www.labs-inc.org.

SOURCE LABS, Inc.


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