Durham, NC, February 3, 2005 -- StemCo Biomedical, Inc. today announced that it has received 510(k) marketing clearance from the United States Food and Drug Administration (FDA) for the use of ALDECOUNT® with bone marrow samples. This marks the third 510(k) clearance for ALDECOUNT, which was cleared by the FDA in 2003 for use in peripheral blood samples both in bulk and single test format.
ALDECOUNT, an in vitro diagnostic, helps clinicians enumerate functional aldehyde dehydrogenase bright, side scatter low (ALDHbrSSclo) cells, which have been shown to possess properties of hematopoietic stem cells. Stem cell enumeration is an important step in the bone marrow transplant process, and approximately 15% of the 45,000 transplants performed annually worldwide use bone marrow as the source of the transplant material. Bone marrow transplantation is being evaluated for treatment of a variety of new indications.
ALDECOUNT now offers clinicians a new approach for detecting hematopoietic stem cells (HSCs) in both peripheral blood and bone marrow samples. The current standard for enumerating HSCs uses CD34 monoclonal antibodies that bind to the cell surface coupled with a viability marker (e.g., 7AAD) to determine the number of cells expected to participate in engraftment. By comparison, enumeration of ALDHbrSSClo cells using ALDECOUNT is based on an enzymatic reaction that can only take place inside metabolically-active cells with intact membranes, thus eliminating the need for an additional viability marker.
ALDECOUNT is available from StemCo Biomedical directly and can be purchased by contacting the company toll free at (877) 484-2571 or via email at email@example.com.
StemCo Biomedical is developing and commercializing proprietary products that improve the identification and selection of more effective adult stem cell populations. These highly unique stem cells have the potential to revolutionize treatments of cancer, cardiovascular disease and other degenerative diseases. For further information please visit the website at www.stemcobiomedical.com.
Back to Portfolio News