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news.China Medical Technologies, a China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, has received approval for its prenatal fluorescent in situ hybridization or FISH probe and cervical cancer FISH probe from the State Food and Drug Administration in the People's Republic of China.
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The Prenatal FISH Probe is a detection kit for the analysis of trisomies 13, 18 and 21 and sex chromosome aneusomies (X and Y). Prenatal screening of trisomy 21 (Down Syndrome) is becoming more prevalent in China and the Prenatal FISH Probe can reportedly provide a quicker and more efficient confirmative approach to the prenatal screening results.
The Cervical Cancer FISH Probe is designed to detect the amplification of the TERC gene in human cervical tissue, which has been demonstrated to be associated with the severity of cervical disorders. Detection of the TERC amplification as a biomarker can provide better assessments of cervical disorders for clinical diagnosis.
The company’s Chinese subsidiaries have received approval for the hi-tech enterprise status from Beijing government authorities. With this status, the subsidiaries are entitled to a preferential income tax rate of 15% which is lower than the statutory income tax rate of 25%. The status is valid for three years and will be renewed after evaluation by relevant government authorities every three years.
Xiaodong Wu, chairman and CEO of China Medical Technologies, said: We are pleased to receive the SFDA approval for two of our FISH probes and achieve the hi-tech enterprise status under new stringent criteria. With the SFDA approval, our hospital customers in different provinces can apply for the inclusion of the two FISH Probes in the reimbursement menu of respective provincial medical insurance programs which we believe will result in increased usage of the probes in the future.