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Chinese FDA approves two of China Medical's FISH probes

This article was originally published in Clinica

Executive Summary

The Chinese state FDA (SFDA) has given the go-ahead to two of China Medical Technologies' fluorescence in situ hybridisation (FISH) tests – the Prenatal FISH probe and the Cervical Cancer FISH probe. The former detects extra copies of chromosome 13, 18 and 21, and sex chromosome additions or deletions. Having three copies of chromosomes 13, 18 and 21 leads to Patau's, Edward's and Down's syndromes, respectively. Well-known sex chromosome disorders include Turner syndrome, where females only have one sex chromosome (X), or Klinefelter's syndrome, where males have an extra X chromosome (XXY). The Cervical Cancer FISH probe detects amplification of the TERC gene in human cervical tissue, which has been linked with the severity of cervical disorders.

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