China Medical receives SFDA approval for 2 diagnostic tests
China Medical Technologies (NASDAQ:CMED) announced Wednesday it has received State Food and Drug Administration (SFDA) approval for its prostate cancer and Topoisomerase 2-alpha (TOP2A) fluorescent in-situ hybridization (FISH) test kits, which tests for Louis-Bar syndrome.
"We have the most comprehensive and largest SFDA-approved FISH product portfolio in China with the nearest competitor only having two SFDA-approved FISH applications," said president of operations, Charles Zhu.
Indeed, China Medical now has eight of its FISH test kits SFDA approved, including detection kits for cancers of the bladder and cervix, for proteins that can lead to lung, anal, breast, and brain cancer, and for prenatal disorder.
These test kits use a fluorescent-labeled probe to detect the presence or absence of specific DNA sequences. The probe is an artificial piece of DNA that can bind to various chromosomes or genes, making them visible under a fluorescent microscope.
The technology enables medical professionals to identify chromosomal abnormalities, including prenatal and postnatal diagnosis, and confirming the prognoses of certain cancers.
In a separate announcement, the Beijing, China-based company said China's Ministry of Health issued clinical guidelines, which included its FISH-based test kits to screen patients with myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and chronic myelocytic leukemia (CML).
"We are excited that FISH tests are now included in the clinical guidelines for MDS, CLL and CML," said CEO Xiaodong Wu.
"Our participation in respective studies conducted by the MOH and the Chinese Medical Association using FISH tests in comparison to other conventional diagnostic tests for certain hematological malignancies have shown positive results for FISH tests."
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