China Medical receives SFDA approvals for TOP2A and prostate cancer FISH detection kits

China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it has received approvals for its prostate cancer FISH detection kit and Topoisomerase 2-alpha ("TOP2A") FISH detection kit from the State Food and Drug Administration (the "SFDA") of the People's Republic of China.

The Company has received SFDA approvals for eight FISH applications including bladder cancer FISH detection kit, cervical cancer FISH detection kit, leukemia BCR/ABL FISH detection kit, prostate cancer FISH detection kit, EGFR FISH detection kit, HER-2 FISH detection kit, TOP2A FISH detection kit and prenatal disorder FISH detection kit.

In addition, the Company has submitted applications to the SFDA for the following products:

FISH kits

  • Lymphoma
  • Miscarriage analysis
  • Myelodysplastic syndromes
  • Soft tissue sarcoma

PCR assay

  • KRAS, a diagnostic assay for colorectal cancer patients on the use of targeted cancer drugs

"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 Mr. Charles Zhu, Senior Vice President of Operations of the Company. "We will continue to maintain this competitive edge over our competitors in the next few years and expect to receive SFDA approvals for the above FISH kits and PCR assay within the next twelve months. We believe that it will take considerable time for competitors to build a similarly broad SFDA-approved FISH product portfolio in China."

Source:

China Medical Technologies, Inc.

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