By Mary Welch

Medical Science Systems Inc. said its genetic risk-factor test for coronary artery disease was able to identify those with increased risk for developing CAD in a pivotal trial.

"We have the patents on the method of using genes for detecting predisposition to gene variations," said Spencer Allen, the company's chief financial officer. "What this test does is evaluate the association of our genetic factors that regulate the inflammatory process with CAD.

"This genetic factor predicts the increased risk for CAD, even after accounting for other risk factors, such as high cholesterol," Allen said. "In fact, it is more likely to predict the risk than some commonly known predictors, such as high cholesterol."

About 500 patients were evaluated at the Mayo Clinic in Rochester, Minn., and a significant association between variants in the interleukin-1 (IL-1) gene cluster and CAD in patients 60 years or younger was found.

Although there are well known predictors for CAD, such as hypertension and smoking, more than half of all first heart attack patients did not have known major risk factors. In recent years, investigators have determined that inflammation in the coronary arteries may explain which patients with atherosclerosis, or the progressive blockage of arteries, actually have a heart attack or stroke. When atherosclerosis occurs in the arteries that supply blood to the heart, the disease is known as CAD. A number of chemical factors participate in the inflammatory response, with one of the most potent being IL-1.

The company foresees this genetic test becoming part of a routine medical examination.

"I think eventually it will become a standard of care, especially for those in the risk zones once they hit 40," Allen said. "I think it will become immediately used by physicians treating people in the gray zone. People who have elevated cholesterol levels but not high enough to immediately warrant controlling drugs. If this test is given, it may help determine if a person gets treated sooner."

The genetic marker involves a finger-sticking blood test, with the drops sent to Medical Science's (MSSI) laboratories in San Antonio. "It comes back a simple yes or no," Allen said. "Yes, you have a risk; no, you don't."

The test should cost in the low $200s, he said.

Since the test's results are not analyzed in the doctor's office, FDA regulations do not apply, Allen said.

"There are no regulatory approvals we have to get," he said. "That's why we did such a large pivotal trial, so that we would have enough data to present findings for them to evaluate. We published the results of the trials in professional magazines and essentially let the peer review of the data determine whether or not it is valid."

The company, founded in 1986, is in early-stage negotiations with a potential partner to take the test to market. MSSI will not market it solo.

The company is conducting additional trials at the University of North Carolina at Chapel Hill. In addition to this test, MSSI is developing tests for asthma, osteoporosis, diabetic retinopathy, meningitis/sepsis and pulmonary fibrosis. MSSI already has launched the PST, a test predictive of risk for periodontal disease. (See BioWorld Today, Feb. 24, 1998, p. 1.)

MSSI's stock (NASDAQ:MSSI) closed Monday at $2.687, up 6.25 cents per share.

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