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FDA Grants AMDL Clearance to Market the AMDL-ELISA DR-70(R) (FDP) Blood Test for Monitoring Colorectal Cancer
Date:7/7/2008

tients thought to be "cured" will develop a recurrence of CRC within 5 years -- usually due to undetected metastases. (Shike M, Winawer SJ, Greenwald PH, et al.: Bull World Health Organ)

Today's announcement marks the first clearance to market that the FDA has granted for any monitoring product for CRC since January 14, 1982 when Carcinoembryonic Antigen (CEA) was approved. Until now, the CEA test has been the only accepted method cleared in the U.S. DR-70 (FDP) offers a new test that can monitor CRC tumors post-surgery.

The DR-70 (FDP) test is cleared in Canada for the detection of lung cancer and was recently cleared to import in Korea and Taiwan as a general cancer screen. It also has the CE mark from the European Union for sale in Europe as a general cancer screen.

About AMDL-ELISA DR-70 (FDP): DR-70 (FDP) is an Enzyme-Linked ImmunoSorbent Assay (ELISA) -- a sensitive, well-established diagnostic laboratory test that can be added easily and inexpensively to the pre-existing line of diagnostics performed routinely by clinical laboratories through out the U.S. Additional information on the AMDL-ELISA DR-70 (FDP) test can be obtained on AMDL's corporate website at http://www.amdl.com or by contacting the Company at 714.505.4460.

About AMDL: AMDL is headquartered in Tustin, CA. with operations in Shenzhen, Jiangxi, and Jilin, China. AMDL, Inc., along with its subsidiary Jade Pharmaceutical Inc. (JPI), is a vertically integrated bio-pharmaceutical company devoted to the research, development, manufacturing, and marketing of diagnostic, pharmaceutical, nutritional supplement, and cosmetic products. The Company employs approximately 320 people in the US and China. The Company has an additional four pharmaceutical and diagnostic products under review by various regulatory authorities.

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