Blood Test and Cancer

Blood Test to Detect Several Types of Cancer Available in US

TUSTIN, CA -- May 15, 2000 -- A simple blood test able to detect the presence in the human body of up to 13 common cancers in their early stages will be available for sale in the United States for the first time this week on a limited basis. Clinical trials of the test - the DR-70™ -- have been successfully conducted in five nations.

AMDL, Inc., developer and marketer of tests for the early detection and monitoring of cancer and other diseases, today said initial sales of the test in the United States will be restricted to hospitals and commercial and research laboratories pending approval for general marketing by the U. S. Food and Drug Administration (FDA). U.S. hospitals and laboratories will be able to purchase the test, as well as make it available to physicians and other medical institutions, under an FDA research exemption.

DR-70 was developed over an 11-year period at a cost in excess of $10 million and, according to AMDL chief executive Gary L. Dreher, is the only known test able to detect several types of cancer at the same time.

“What the test does,” Mr. Dreher says, "is let a person know with a high degree of specificity if he or she has one or more of the 13 most serious and most common cancers. That is the sole purpose of the test. If positive, other standard tests could be employed to determine the specific cancer."

He said the DR-70 is non-invasive, inexpensive - "at the hospital level, probably no more than $100 a test per patient" - and can be completed within a matter of hours.

The 13 cancers detectable by DR-70, Mr. Dreher says, include cancers of the lung, colon, breast, stomach, liver, rectum, ovary, esophagus, cervix, trophoblast, thyroid, malignant lymphoma and pancreas.

Clinical trials have been conducted, and in some instances continue to be conducted, in China, Taiwan, Chili and Turkey. Results of the trials, in which the tests detected the presence of one or more of the 13 cancers 84 percent of the time overall, were published in the peer-reviewed medical journal, "The Journal of Immunoassay."

He said the benefits of the test are "meaningful not only from a medical and humanitarian perspective but also in terms of cost." He said the cost factor "probably would overcome the monetary concerns of insurance companies and health maintenance organizations over the use of a new test."

Mr. Dreher noted that "currently, once a person is diagnosed as having a specific cancer, the cancer often is too far along to cure or manage successfully. Thus, in most cases, that means many years of suffering, treatment, or both, and the possibility of an earlier-than-normal demise." He said the treatment of cancer has been shown to have a better success rate if diagnosed early.

He said one of the major problems in dealing with cancer today is that many cancers are symptom-free in their early and mid stages. "Additionally," he said, "a physician, as a matter of routine, may order a test for a specific cancer, such as ovarian cancer or prostate cancer, but the patient may, in fact, have another cancer not detectable by the test the doctor ordered. Thus, the patient's cancer is often undiagnosed until it is too late."

"Since early diagnosis has many advantages and since most cancers in their early stages do not show any symptoms," Mr. Dreher said, "it's just common sense to spend $100-or-so every year or two, say, after you’re 30 or 35, to learn whether you have cancer."

He said clinical trials undertaken for the DR-70 in China, Chili, Turkey and Taiwan produced "extremely favorable results, detecting 13 types of serious cancer with a remarkable degree of sensitivity and accuracy." At the moment, Mr. Dreher said, significantly larger DR-70 trials are being conducted in China that, if as successful as the original trials, may lead to nationwide screening of all at-risk civilians in China and, over time, members of the military.

He said AMDL has entered into a Memorandum of Understanding with the Union Medical & Pharmaceutical Group/Beijing Union Medical & Pharmaceutical General Corporation (Union) to establish a joint venture for marketing, distribution and manufacture of AMDL products in China. Mr. Dreher said that Union, with its distribution channels to some 2,000 hospitals, is expected to be instrumental in obtaining the necessary central Chinese government approvals required for importation, sale and manufacture of IVD testing products in China.

Mr. Dreher said the test "simply quantifies the amount of DR-70 tumor marker in a patient's sera. As with many laboratory tests, the DR-70 requires a patient to fast after the evening meal. The next morning approximately 2 cc of whole blood is taken from a venous specimen from a patient's arm. The laboratory uses the serum portion of the blood for testing. The test can be completed in a couple of hours."

Another of AMDL's proprietary products, the PyloriProbe, already approved for general marketing by the FDA, detects antibodies to H. pylori, a bacterium that has been shown to cause stomach cancer in some individuals if left untreated.

The company's third propriety product, OncoChek, is being developed simultaneously alongside the DR-70 product and has been in pre-clinical trials. After the pre-clinical trials were initiated, an IVD Technology study noted that OncoChek possesses a competitive advantage over other available products in that it can provide early detection for numerous forms of cancer through significantly increased specificity and sensitivity, thereby making possible the earlier and more effective initiation of treatment for cancer patients.

In addition to its proprietary products, the company also offers a full line of non-proprietary cancer tumor markers, including CEA for colon cancer, PSA for prostate cancer and AFB for liver cancer.

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The information on this page has been extracted from http://www.pslgroup.com/dg/1d1b8a.htm.