Medical device company China Medical Technologies Inc. (CMED), Monday announced that the State Food and Drug Administration of China, or SFDA, has given approval for its Leukemia BCR/ABL FISH Probe, a test for detecting the gene with a critical chromosomal abnormality associated with some of the most common types of leukemia.
The Leukemia BCR/ABL fusion gene FISH Probe is a molecular diagnostic test kit that uses DNA probes for accurate detection of Philadelphia translocation, a specific chromosomal abnormality commonly seen in patients with chronic myelogenous leukemia or CML, acute lymphoblastic leukemia or ALL and acute myelogenous leukemia AML.
The translocation results when a fusion gene is created by the juxtapositioning of a part of the Breakpoint Cluster Region or BCR gene from chromosome 22 to the Abelson or ABL gene on chromosome 9, during a mis-matched reciprocal translocation between them.
The FISH or Fluorescent in situ hybridization technique uses fluorescence-labelled DNA Probes that hybridize with the specific target region on the chromosome, thereby allowing clinical detection through a fluorescent microscope. The Leukemia BCR/ABL FISH Probe contains specific probes for the detection of the abnormal Philadelphia translocation gene.
Once detected, the Philadelphia translocation can act as a critical diagnosis and prognosis guide for selecting different treatment protocols for patients with CML, ALL and AML. Leukemia or blood cancer, causes almost 3% of all cancer-related deaths in the world.
Beijing-based China Medical Technologies also noted that it has received SFDA approvals for all the major FISH probes that it acquired as part of the FISH business in March 2007. Apart from the FISH business, the company makes enhanced chemiluminescence immunoassay technology and surface plasmon resonance technology-based products.
CMED is currently trading at US$15.01, up US$0.01 or 0.07% on the Nasdaq.
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