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The purpose of this independent study was to evaluate the potential of theDR-70 ELISA (FDP) test as a detection test for gastrointestinal cancers thatinclude, colorectal, esophageal, gallbladder, gastric, liver, pancreatic andintestinal cancers. Additionally, the quantitative value of DR-70 (FDP) wastested as a parameter for the progression of these cancers. Serum sampleswere taken from a total of 80 cancer patients with histologically provenmalignant tumors and 100 healthy blood donors in this study. Patients withcolorectal cancer were also tested for carcinoembryogenic antigen (CEA), acompeting diagnostic test to AMDL-ELISA DR-70 (FDP). The complete articleabout AMDL-ELISA DR-70 (FDP) can be accessed via AMDL's corporate websitelocated at www.amdl.com under the RESOURCES link.
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"When we compared the DR-70 immunoassay with conventional tumor markers,DR-70 turned out to be superior to CEA in the detection of patients withcolorectal cancer," according to the conclusion of authors. The authors alsoconcluded that DR-70 (FDP) levels were shown to be significantly higher acrossall types of gastrointestinal cancers tested and not limited to specific tumortypes, suggesting the AMDL-ELISA DR-70 (FDP) test could be clinically used asa global cancer detection tool.
About AMDL: Headquartered in Tustin, CA with operations in Shenzhen,Jiangxi, and Jilin, China, AMDL, Inc., along with its subsidiary JadePharmaceutical Inc. (JPI), is a vertically integrated bio-pharmaceuticalcompany devoted to the research, development, manufacturing, and marketing ofdiagnostic, pharmaceutical, nutritional supplement, and cosmetic products. Thecompany employs approximately 320 people in the U.S. and China. The AMDLELISA DR-70 (FDP) cancer diagnostic test was cleared to market by the US FDAon July 13, 2008 and the Company has 4 additional pharmaceutical anddiagnostic products under review by various regulatory authorities. Foradditional information on AMDL and its products visit the company's website atwww.amdl.com or call +1 (714)505-4460.According to the results: -- The AMDL-ELISA DR-70 (FDP) test showed strong clinical performance with a sensitivity of 91% and a specificity of 93% in testing conducted on patients with hepatocellular, cholangiocellular, pancreatic, colorectal, stomach and oesophagus cancers. -- The test reliably differs between patients with cancer of the gastrointestinal tract or the hepatobilary system and healthy patients; therefore showing promise as a useful cancer detection tool in clinical practice. -- The study also found an association between the quantitative DR-70 value and the stage of the cancer in patients tested which suggests the AMDL-ELISA DR-70 (FDP) test can also be used as a prognostic factor in cancer monitoring.
SOURCE AMDL, Inc.
