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Roche To Develop Companion Diagnostic Test For Acute Coronary Syndrome

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Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced it has entered into an agreement to develop a companion diagnostic (CDx) test for dalcetrapib, a therapeutic from DalCor Pharmaceuticals (DalCor), which will target patients with a specific genotype who have experienced a recent Acute Coronary Syndrome (ACS) event. The CDx test from Roche will be used in a phase III clinical trial that will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the Montreal Heart Institute, could potentially reduce cardiovascular morbidity and mortality by as much as 39 percent in patients with a specific genetic profile.

“At Roche, we understand the importance of forging partnerships that make significant impacts on patient lives,” said Paul Brown, Head of Roche Molecular Diagnostics. “Our first companion diagnostic test in cardiovascular disease represents a significant innovation, and leverages our expertise in developing FDA approved CDx tests. Working with DalCor is a good opportunity for us to enter this market and deliver on our mission of personalized healthcare.”

“The possibility of reducing morbidity and mortality for patients who have experienced ACS by identifying genetic markers that can respond to therapy, is an exciting prospect and one that we are eager to be a part of,” said Robert McNeil, CEO, DalCor Pharmaceuticals. “The DalCor and Roche collaboration for the genetic testing is the right combination for successful execution of the phase III trial.”

ACS is a disease that affects patients globally. It occurs when the blood supply to the heart muscle is suddenly blocked. The disease accounts for more than one million hospital admissions annually in the United States alone. According to the American Heart Association, approximately every 34 seconds, an American will experience a coronary event, and approximately every one minute, an American will die from one. Patients who survive an ACS event carry a significant risk for a recurrent episode. The test from Roche, which is still in development, will identify a specific genetic variation from patients with recent ACS and aid in determining if a patient is eligible to receive the therapeutic.

Source: Roche