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SFDA Clears China Medical Technologies Automaglia 90, Down Syndrome Screening

China Medical Technologies, an in-vitro diagnostic (IVD) company, has received approval for Automaglia 90 fully-automated ECLIA analyzer (Automaglia 90) as well as Down Syndrome screening kit (Down Syndrome Screening) from the State FDA of China (the SFDA).

Automaglia 90 Analyzer is a fully-automated analyzer for immunoassay analysis in various types of diseases and disorders. Major clinical diagnostic applications include thyroid disorders, fertility and infertility disorders, diabetes, infectious diseases and tumor markers.

China Medical Technologies expects Automaglia 90 Analyzer to enter a new customer segment of its ECLIA business by targeting large hospitals in China which have the highest patient volume and consumable usage. The company will leverage its own direct sales force to cross sell Automaglia 90 Analyzer to existing FISH customers which comprise over 400 large hospitals in China.

Down Syndrome Screening is used for prenatal screening tests for trisomy 21, a chromosomal disorder caused by the presence of all or part of an extra 21st chromosome. China Medical Technologies plans to bundle Down Syndrome Screening with its Prenatal FISH Probe, a molecular diagnostic test for the detection of various prenatal disorders with a view of serving a huge group of pregnant women in China at an estimated size of over 16 million each year.

Xiaodong Wu, chairman and chief executive officer of China Medical Technologies, said: “We are pleased to receive SFDA approval for both Automaglia 90 Analyzer and Down Syndrome Screening. We expect the approved products to broaden our customers and increase usage of our consumables. We look forward to receive SFDA approval for our HPV DNA Chip which is also expected to broaden our customers and increase our consumable usage.”