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China Medical Technologies Receives SFDA Approval for its Fu

发布日期:2019-01-31 作者:918

BEIJING, April 29 /PRNewswire-Asia/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it received approval for its AUTOMAGLIA 90 fully-automated ECLIA analyzer ("AUTOMAGLIA 90 Analyzer") as well as Down Syndrome screening kit ("Down Syndrome Screening") from the State Food and Drug Administration 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. The Company 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. 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.

"We are pleased to receive SFDA approval for both AUTOMAGLIA 90 Analyzer and Down Syndrome Screening," said Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company. "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."

About China Medical Technologies, Inc.

China Medical Technologies, Inc. is a leading China-based advanced IVD company using molecular diagnostic technologies including Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology as well as Enhanced Chemiluminescence Immunoassay (ECLIA) technology, an immunodiagnostic technology to develop, manufacture and distribute diagnostic products for the detection of various cancers, diseases and disorders. The Company generates all revenues in China by selling diagnostic consumables including FISH probes, SPR-based DNA chips and ECLIA reagent kits to hospitals which are recurring users of the consumables for their patients. The Company sells FISH probes and SPR chips to large hospitals through its direct sales force and ECLIA reagent kits to small and mid-size hospitals through distributors. For more information, please visit http://www.chinameditech.com .

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in the Company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

For more information, please contact:

Winnie Yam

Tel: +852-2511-9808

Email: IR@chinameditech.com

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