New Colon Cancer Test
Has Received Approval for Patient Testing -
Breakthrough Blood Test for Recurrent Cancer -
|Targeted Diagnostics & Therapeutics, Inc. (TDT) announced today that it has received regulatory approval to immediately begin offering its powerful new blood test (called GCC-B1(TM)) for the detection of recurrent colorectal cancer. TDT has been certified under the Federal Clinical Laboratories Improvement Amendment of 1988 (CLIA '88) for high-complexity laboratory testing. |
"We now can provide physicians and their patients with highly sensitive and specific testing for the detection of recurrent colorectal cancer," said Harry Arena, President & CEO. "By adding GCC-B1(TM) to monitoring protocols, physicians will have a powerful new tool to detect the presence of metastatic colorectal cancer cells in their patients. This could lead to much earlier detection of recurrent disease, which can be critical to the physician's ability to intervene effectively," Arena said.
Prior to this announcement, the test most commonly used for monitoring patients for recurrent disease has been a test for carcinoembryonic antigen (CEA), a general tumor marker developed almost 40 years ago. Unfortunately, the presence of CEA varies widely from patient-to-patient, and over 30% of tumors do not produce CEA at all. Also, CEA values are subject to influence by other medical and non-medical conditions, resulting in high rates of both false negatives and false positives. The consequence is a test which can fail to detect tumors as often as 40% of the time. Physicians have long been aware of these limitations, but until now, CEA has been the only surveillance tool available.
TDT's new test, GCC-B1(TM), represents a major breakthrough because its powerful detection mechanism finds metastatic colorectal cancer that is often missed by other methods. GCC-B1(TM) can find 1 cancer cell in 10,000,000 normal cells by detecting the presence of guanylyl cyclase C (GC-C), which is found on metastatic colorectal cancer cells. Detection of the presence of this marker in the blood is indicative of recurrent metastatic colorectal disease. In on-going clinical testing, the GCC-B1(TM) test has been shown to have as high as 100% sensitivity and 91% specificity.
Colorectal Cancer is second only to lung cancer in the number of deaths it causes each year. About 150,000 Americans will be diagnosed this year with colorectal cancer, striking men and women almost equally, and almost 60,000 people will die from it, according to the American Cancer Society. There is an estimated recurrence rate of over 40% within 5 years, and patients are typically monitored throughout that period, usually with CEA. For the roughly 450,000 Americans who are currently being monitored for recurrent colorectal cancer, the launch of this new, extremely sensitive and specific GCC-B1(TM) blood test brings new hope for improving the rate of survival.
"The purpose of this test is to offer physicians a new tool to reduce the mortality and medical consequences associated with the recurrence of this disease," said Arthur Boyce, Vice President of Marketing & Business Development. "Early detection of recurrent metastatic cells gives physicians an opportunity for earlier intervention, when the cancer may be easier to treat and a broader range of treatment options may be available," Boyce said. In its 2000 Update of Colorectal Cancer Surveillance Guidelines, the American Society of Clinical Oncology (ASCO) called for improved surveillance methods to detect colorectal recurrences when resection or systemic treatment may prolong survival. "TDT is responding to that call with the launch of the GCC-B1(TM) blood test, and other tests to follow," Boyce, said.
Under CLIA '88 certification, the GCC-B1(TM) blood tests can be processed only in TDT's laboratories in West Chester, Pennsylvania. TDT is prepared to accept patient specimens for testing from anywhere in the U.S. and the rest of the world. A collection kit with all of the components required for the collection and transport of patient blood specimens is available for immediate order. TDT has literature and order forms ready to respond to inquiries from both patients and physicians. Information is also available on the TDT's website, http://www.tdtinc.com. Tests are conducted under the orders of a physician and results are sent to that physician for interpretation and subsequent discussion with their patients.
Targeted Diagnostics & Therapeutics, Inc.
TDT is a biotechnology company with a substantial patent portfolio and a commitment to research in the area of discovery and development of molecular- based technologies. These technologies focus on the targeted detection and treatment of cancer, infectious diseases, and gastrointestinal disorders. Since its inception in 1994, TDT has been successful in developing highly specific novel diagnostic markers and therapeutic targets for gastrointestinal malignancies including colon, rectal, gastric, and esophageal cancer. The blood test currently being launched is used for detecting the recurrence of colorectal cancer in the blood of patients undergoing postoperative surveillance. A lymph node test which will be used for staging patients with colorectal cancer is expected to be approved for launch later in the year. The GC-C technology is also being applied as a mechanism for targeting and delivering therapeutic agents directly to colorectal cancer cells and TDT has granted a license to Millennium Pharmaceuticals, Inc., in Cambridge, Massachusetts, for these therapeutic applications. TDT is headquartered in West Chester, Pennsylvania.
Editor's Note: This release is available on TDT's website at http://www.tdtinc.com
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Colorectal Cancer is second only to lung cancer in the number of deaths it causes each year. About 150,000 Americans will be diagnosed this year with colorectal cancer, striking men and women almost equally, and almost 60,000 people will die from it, according to the American Cancer Society.
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