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April 17, 2014
08:32 EDTLH, ABIOARCA Biopharma announces screening of first patient in Phase 2B/3 trial
ARCA biopharma announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial. The GENETIC-AF trial will evaluate Gencaro as a potential treatment for the prevention of atrial fibrillation in patients with heart failure and/or left ventricular dysfunction who also have a specific genotype of the beta-1 adrenergic receptor, which is believed to be present in approximately 50% of the U.S. population. There are currently seven active clinical trial sites recruiting patients for GENETIC-AF. The company anticipates having approximately 50 clinical trial sites for the Phase 2B portion of the trial. Last week, ARCA hosted the initial GENETIC-AF Investigator Meeting which brought together the physicians and research coordinators participating in the trial for information sharing and study-specific training.
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April 21, 2015
08:14 EDTLHQuest Diagnostics and Inserm launch BRCA Share initiative
Quest Diagnostics (DGX) and Inserm, the French National Institute of Health and Medical Research institution, launched BRCA Share, a novel datashare initiative they co-founded to provide scientists and laboratory organizations around the world with open access to BRCA1 and BRCA2 genetic data. The program's goal is to accelerate research on BRCA gene mutations, particularly variants of uncertain significance, to improve the ability of clinical laboratory diagnostics to predict which individuals are at risk of developing hereditary breast and ovarian cancers. Laboratory Corporation of America Holdings (LH) is the first participant in the initiative, which is structured as a user group. B
06:40 EDTLHStart-up to offer saliva test for breast cancer susceptibility, NY Times says
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April 13, 2015
08:33 EDTABIOARCA Biopharma receives FDA fast track designation for Gencaro AF development
ARCA biopharma announced that the U.S. Food and Drug Administration has designated as a Fast Track development program the investigation of Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population. Gencaro is the company’s investigational, pharmacologically unique beta-blocker and mild vasodilator. Gencaro is currently being evaluated as a potential treatment for atrial fibrillation in a genetically-defined heart failure population in GENETIC-AF, a Phase 2B/3 adaptive design clinical trial. ARCA anticipates that enrollment of approximately 200 patients in the Phase 2B portion of the trial will be completed by the end of 2016.

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