AMDL says German researchers found DR-70 superior in detecting ovarian carcinoma

By E. Janene Geiss

Philadelphia, Feb. 27 - AMDL, Inc. announced Monday that researchers from Johannes Gotenberg University in Germany tested the diagnostic validity of the company's DR-70 cancer test kit compared to CA-125, the standard test, as a tumor marker for the detection of ovarian carcinoma.

The researchers simultaneously investigated the serum activities of the two tests with 61 preoperative patients with histologically confirmed ovarian carcinoma and 100 healthy people, according to a company news release.

The specificity - determining the presence of cancer - for DR-70 in the test was 100% and sensitivity - determining the type of cancer - was 83.6%, 13.1% higher than the CA-125 test, officials said.

The German researchers concluded that "DR-70 represents a tumor marker with which ovarian carcinoma can be diagnosed at levels of sensitivity and specificity which compare favorably to those measured with CA-125," officials said in the release.

The study is published in the German Journal of Obstetrics and Gynecology.

Researchers said that the DR-70 immunoassay quantifies the amount of fibrin degradation products in the body, which is produced from malignant cells.

DR-70 "has successfully been used for the detection of a number of cancers including lung, stomach, breast, rectum, liver, colon and uterus cancer," the German researchers said in the article.

The company said its primary objective remains receiving Food and Drug Administration clearance to market DR-70, which would simultaneously increase market awareness and acceptance in the international marketplace.

AMDL is a Tustin, Calif., theranostics company involved in the detection and treatment of the same disease, cancer.

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