InoLife Technologies announced it will provide and market a proprietary metabolizing test to physicians and practitioners to identify how a patient’s genetic makeup may affect the body’s response to Plavix (colpidogrel).
The test will only be made available to physicians.
The Food and Drug Administration recently announced that Plavix must now carry a so-called "black box" warning label after a landmark study revealed that patients who were "non-responders" as a result of a genetic variation were "3.58 times more likely to have a fatal stroke or myocardial infarction."
Plavix, an $8-billion-a-year drug and considered to be the second best selling drug in the world, reduces the risk of heart attack, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.
"We determined that there are three critical problems that can lead to a level of non-response to Plavix," said Dr. Frederic J. Vagnini, M.D., FACS, a board certified cardiovascular surgeon who, after more than 20 years of performing heart surgery, has turned his clinical practice to the prevention of heart and related diseases. "First, in anyone an abnormality may be present within a gene abbreviated as CYP2C19 (and other variants) which significantly increases the risk of stroke or death due to clotting failure. Second, there are different variants or mutations between ethnic groups; some studies have indicated that one in three Caucasians and 40% of Asian of African-American populations have this abnormality.
"Among clinicians there have been discussions centering on differing dosing approaches. Perhaps the most important result of InoLife’s DNA test is that each patient will be able to have an individually tailored course of treatment since some require longer periods on it," Vagnini stated.
Source: InoLife Technologies
