HemoGenix Inc. Introduces HALO(R)-96 PQR, the First Stem Cell Potency and Release Assay to Incorporate a Reference Standard
Published: Dec 05, 2007
COLORADO SPRINGS, Colo., Dec. 5 /PRNewswire/ -- HALO(R)-96 PQR addresses the requirement by Standards Organizations and Regulatory Agencies for an "appropriate" and "validated" assay that can be used by cord blood banks and stem cell transplantation centers to determine whether a stem cell product has the necessary potency characteristics and can be released for transplantation into a patient.
HALO(R)-96 PQR (Cell Potency Quality Release Assay) is the latest in a long line of in vitro assays purposely designed and developed by HemoGenix(R) for a highly specialized application, namely to quantify the potency of a cellular product used for transplantation into human patients. Although not required for bone marrow and mobilized peripheral blood transplants, the ever-increasing use of cryopreserved umbilical cord blood as a source of transplantable stem cells for both children and adults, has required other regulations to be mandated by both Standards Organizations and the U.S. Food and Drug Administration (FDA). These require that "appropriate" and "validated" assays be used to ascertain the potency and release criteria of a product for transplantation into a patient. Use of an umbilical cord blood unit is presently based on cell number, rather than the potential for the cells to proliferate.
HALO(R)-96 PQR is a 5-day, fully standardized ATP bioluminescence proliferation assay that can be easily validated both within and between laboratories. HALO(R)-96 PQR is the first and only cell potency and release assay that includes a reference standard to which samples can be compared and their potency quantified. Acceptance limits can also be defined, allowing release criteria to be used for the product prior to its being transplanted into a patient, thereby providing greater safety.
HemoGenix(R), a Colorado Springs based company started in 2000, was the first to provide a fully standardized ATP-based, in vitro bioluminescence assay system designed specifically as a replacement for other assays that have been used for over 40 years. HemoGenix(R) develops, produces and sells its own portfolio of proprietary assays directly or through its distributors worldwide. Market areas include academia, the biopharmaceutical and environmental arena and, stem cell transplantation processing laboratories.
Ivan N. Rich, PhD, Founder and CEO of HemoGenix(R) said that "the introduction of HALO(R)-96 PQR, takes stem cell transplantation quality control to a level that far exceeds what Standards Organizations and the FDA have mandated."
CONTACT: Dr. Ivan N. Rich, Founder and CEO of HemoGenix, +1-719-264-6250
Web site: http://hemogenix.com/