HemoGenix, Inc Announces A Reference Standard, Stem Cell Potency Quality Release Assay

HemoGenix^® announces HALO^®-96 PQR, the first Stem Cell Potency Quality Release Assay to incorporate a reference standard. HALO^®-96 PQR addresses the requirement by Standards Organizations and Regulatory Agencies for a "meaningful", "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^®-96 PQR will be unveiled at the American Society of Hematology (ASH) in Atlanta, GA, December, 8, 9 and 10, 2007.

HALO^®-96 PQR (Potency Quality Release) is the latest in a long line of in vitro assays purposely designed and developed by HemoGenix^® 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. To date, the criteria for using a unit of umbilical cord blood has been primarily based on whether sufficient cells (cell number) were present as well as the viability (number of live cells) and presence of markers that designate or identify the presence of stem cells. However, these do not provide information on whether the cells will engraft into the patient when transplanted. For this, the colony-forming cell (CFC) assay has been used. First used in 1966, the CFC assay was never designed as a quality control, let alone a cell potency assay. Besides being a retrospective assay and taking 14 days to complete, it has many other drawbacks, the most important being the inability to standardize the assay against an external standard and therefore to validate it. As such, it is inappropriate as a cell potency assay.

In contrast, HALO^®-96 PQR is not only fully standardized and therefore can be validated both within and between laboratories, but only takes 5 days to obtain results. More important is the inclusion of a reference standard that now allows the response of a cell product to be compared directly to a known standard. Furthermore, rather than basing the use of a cellular product on the number of cells present, it is now possible to introduce acceptance limits, with respect to proliferation capability, and therefore release criteria for the product prior to transplantation. This would provide increased safety both for the patient and physician.

For more information on stem cell potency testing, or to download the White Paper entitled "Cell Potency Assays for the 21st Century Stem Cell Transplantation and Cord Blood Storage Processing Laboratories", please contact HemoGenix^®.