CMTR is simply distributing the test. It was developed by Helena Labs of Beaumont, Texas.
SUNNYVALE, Calif.--(BW HealthWire)--Feb. 5, 1997-- Chemtrak Inc announced Wednesday that it will soon introduce
ColoCARE, a home test for the early detection of colorectal disease which is FDA-cleared, low-priced and clinically accurate.
The ColoCARE test is noninvasive, sanitary and easy-to-use.
"Our decision to bring ColoCARE to the U.S. market is in direct response to the test's proven ability to screen for the
warning signs associated with this type of cancer and new medical guidelines currently being issued," said ChemTrak Chief
Executive Officer, Edward F. Covell.
The company has signed a distribution agreement with test developer Helena Labs (Beaumont, Texas).
"ChemTrak has an ongoing business relationship with leading pharmaceutical companies and other medical device
companies, including Astra-Merck, SelfCare, Helena Labs and others. Our decision to launch ColoCARE has been
reinforced by important new information recently presented by the American Cancer Society and other health experts," Covell
added.
Colorectal cancer now accounts for over 55,000 deaths in the United States each year. It is the nation's second leading cancer
killer with 131,000 Americans diagnosed annually. According to the American Cancer Society and seven other medical
groups, this type of test can be as effective in detecting colorectal disease as mammograms are for breast cancer detection. If
used annually by persons over fifty, it is believed that colorectal cancer screening tests, such as ColoCARE, could cut deaths
by one-third.
The ColoCARE test is easy to use, sanitary and reliable. Used in the privacy of the bathroom, the user simply removes the
test pad from its envelope and drops it into the toilet following a bowel movement and before flushing.
Chemicals in the pad cause it to turn blue within 30 seconds if hidden blood is present in detectable amounts. The presence of
blood in the stool is a recognized early warning sign of colorectal disease including cancer. The user notes any color change,
records the information and flushes the toilet. No messy sample handling is required. Three consecutive tests are required. If,
during any of the tests the pad turns blue, a physician should be consulted as soon as possible. The test pad should not
change color if blood is not detected.
"Like ChemTrak's other diagnostic tests, the ColoCARE system is clinically reliable and user-friendly. Given its price and
convenience, responsible adults should consider self-testing once a year," said Covell.
Who should consider the test? The disease strikes men and women about equally; those over forty may be increasingly
sensitive. Anyone with a personal or family history of lower intestinal disorders, colorectal cancers, or other cancers, should
take this test yearly or as often as recommended by a doctor.
As reported in USA Today, "An easy take home test for colorectal cancer could lower the cost and unpleasantness that deter
many Americans from being examined for the nation's leading cancer killer." And, information from the American Cancer
Society makes it clear that early cancer detection is of critical importance.
ColoCARE has already received FDA clearance to be marketed and will soon be available in stores and pharmacies across the
United States and will retail for less than $7. It will be marketed alongside ChemTrak's other home personal diagnostic
products.
"This test is of great significance and we're exceedingly pleased to bring it to market at this time," Covell concluded.
Currently, ChemTrak's CholesTrak Home Cholesterol Test, the first FDA-approved product of its kind, is available
internationally and in most retail pharmacies and mass merchandise outlets in the United States. ChemTrak has also received
FDA marketing clearance for its single-use, whole blood, physician's office test for Helicobacter Pylori (H. pylori), the
bacterium now recognized as a contributor to duodenal and peptic ulcers in humans. The company's home HIV test system is
pending FDA approval in the United States.
NOTE: Statements in this release that relate to product performance, customer acceptance, market conditions, and new
product plans are forward-looking statements. Actual results might differ materially from these statements due to risks and
uncertainties -- including determinations by the FDA, the impact of competitive product and pricing, the timely development
and acceptance of new products, and medical market conditions. |
