Technology | July 26, 2012

Transgenomic Announces Medicare Coverage for Clopidogrel Response Test

July 26, 2012 — Transgenomic Inc. has announced that National Government Services, the designated Medicare fiscal intermediary in Connecticut, has confirmed coverage for its proprietary Clopidogrel Genetic Absorption Activation Panel (C-GAAP, formerly PGxPREDICT: Clopidogrel). As a result of this coverage, the 48 million Americans currently covered by Medicare will have access to this genetic test. The C-GAAP is a clinically validated diagnostic test that identifies patients with genetic variations in CYP2C19, a gene whose effect is described in clopidogrel’s label, and ABCB1, a gene that is unique to Transgenomic’s panel and is covered by issued and pending patents owned by Transgenomic.

The effectiveness of clopidogrel, the most widely prescribed antiplatelet drug used to reduce the risks of heart attack, stroke and death, is dependent on a patient’s ability to absorb the drug through their intestine and then activate the drug by enzymes produced in the liver. Two genes, ABCB1 and CYP2C19, encode proteins critical for this absorption and activation. Patients with dysfunctional CYP2C19 and ABCB1 genes treated with clopidogrel exhibit a 50 percent increase in major adverse cardiovascular event rates than do patients with normal CYP2C19 and ABCB1 genetic function. The seriousness of this problem prompted the U.S. Food and Drug Administration (FDA) to add a black box warning to clopidogrel’s label in 2010 to alert physicians and patients about this cardiac risk and the usefulness of genetic testing in guiding treatment strategies. Subsequently, professional medical societies, including the American College of Cardiology and the American Heart Association, have issued practice guidelines recommending the consideration of genetic testing for patients at high-risk for poor clinical outcomes.

Transgenomic’s C-GAAP is a simple saliva test that identifies patients who cannot completely absorb or activate clopidogrel due to reduced function of CYP2C19 or ABCB1. C-GAAP analyzes markers in both genes to identify patients who are at a genetically increased risk of major adverse cardiovascular events due to diminished effectiveness of clopidogrel. Approximately 50 percent of patients taking clopidogrel have markers in CYP2C19 or ABCB1 indicative of reduced absorption or reduced activation of clopidogrel.

For more information: www.transgenomic.com

 

Related Content

Xarelto Reduces Ischemic Stroke for Coronary and Peripheral Artery Disease Patients
News | Antiplatelet and Anticoagulation Therapies | February 19, 2018
A late-breaking analysis of the landmark COMPASS study was presented at the 2018 International Stroke Conference (ISC...
Abbott Begins Enrollment in XIENCE 28 GLOBAL DAPT Trial
News | Antiplatelet and Anticoagulation Therapies | February 13, 2018
Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet...
Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
Technology | Antiplatelet and Anticoagulation Therapies | January 22, 2018
January 22, 2018 — Baxter International Inc. announced the U.S.
News | Antiplatelet and Anticoagulation Therapies | January 19, 2018
The U.S. Food and Drug Administration (FDA) announced that International Laboratories LLC is voluntarily recalling Lot...
New Oral Anticoagulant Drugs Associated with Lower Kidney Risks
News | Antiplatelet and Anticoagulation Therapies | December 12, 2017
Mayo Clinic researchers have shown a link between which type of oral anticoagulant a patient takes to prevent a stroke...
News | Antiplatelet and Anticoagulation Therapies | November 16, 2017
Bristol-Myers Squibb Company and Pfizer Inc. released real-world data (RWD) of outcomes associated with direct oral...
Six Months of DAPT Non-Inferior to Twelve in STEMI Patients Receiving Drug-Eluting Stents
News | Antiplatelet and Anticoagulation Therapies | November 06, 2017
November 6, 2017 —  The first trial to evaluate the safety of...
Statins Attributed With 10-Year Cholesterol Drop for Malaysian Heart Attack Patients
News | Antiplatelet and Anticoagulation Therapies | November 03, 2017
November 3, 2017 — A ten-year decline in the blood cholesterol of heart attack patients in Malaysia suggests...
COMPASS Trial Shows Rivaroxaban With Aspirin Improves Stable Cardiovascular Disease
Feature | Antiplatelet and Anticoagulation Therapies | September 12, 2017
September 12, 2017 — Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies | August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Overlay Init