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SFDA okays CMT's ECLIA analyzer, Down syndrome kit

Singapore, Apr 30, 2010: China Medical Technologies (CMT), a China-based in-vitro diagnostic company, said that it has received approval for its Automaglia 90 fully-automated ECLIA analyzer as well as Down syndrome screening kit from the State Food and Drug Administration (SFDA) of China.

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. CMT 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 release noted that the company would 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. The company 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.

© BioSpectrum Bureau
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