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LABS, Inc. Launches Suite of Next-Generation Test Offerings; Focuses on Expanding Complex Biologic Testing Portfolio in 2012
Date:3/21/2012

eagents. The assay is not intended to be used for final lot release unless a secondary validation is performed and incorporated into a regulatory product application.
  • VDmax sterilization and dose audits: a simplified validation method for sterilizing human allograft products such as bone, osteobiologic putties and soft tissues comprised of ligaments and tendons, through the use of radiation. This method is also very useful for the validation of associated materials used during the processing of allograft products such as packaging, syringes, sample containers, etc. Upon successful completion of the validation, quarterly dose audits are performed to confirm that the sterilization dose initially determined for the product is still appropriate over time. 
  • Blood spot and buccal swab Human Leukocyte Antigen (HLA) analysis: a simplified method, requiring lower sample volume, for collecting DNA samples for HLA typing, which is used to match donors and recipients for cell-based transplants and transfusions. These new methods are particularly valuable in situations when whole blood samples are scarce or unavailable.  The blood spot method uses a single drop of blood applied to an FTA™ card, which contains a proprietary formula to capture and preserve the blood sample for testing. The buccal swab method doesn't rely on the availability of blood to collect the required DNA for analysis, instead using a sterile swab to collect cells containing DNA from the inside of a cheek.
  • Endotoxin testing: endotoxins are toxic substances derived from gram negative bacteria and can be associated with biologics, biopharmaceuticals, medical devices, packaging materials and water purification systems. Complex biologic products present a formidable challenge to the standard endotoxin instruments and testing methods since there is typically an inherent level of inhibitory substances present within them. LABS has extensive e
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