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Boston Heart Dx Completes New York's Clinical Lab Permitting Process

NEW YORK (GenomeWeb News) – Boston Heart Diagnostics today announced it successfully completed the New York State Department of Health clinical laboratory permitting process.

As a result, the company can administer its tests to patients in all 50 states in the US.

Among the tests offered by BHD is the Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype test, which identifies patients at higher risk of developing statin-induced myopathy due to a variation on their SLCO1B1 gene. By identifying such patients, doctors can better evaluate which drugs to prescribe at appropriate doses, BHD said on its website. It added that the test is the only one in the US that is commercially available under license for SLCO1B1 genotyping.

The company also offers genetic tests targeting ApoE, Factor V Leiden, prothrombin (Factor II), and CYP2C19.

Citing statistics from NYSDOH, BHD said that in 2011 more than 50,000 New Yorkers died from heart disease and stroke.

Requirements for a permit from the state include certification of a director and/or assistant directors for each test category; an on-site inspection to ensure that premises, laboratory practices, equipment, personnel, and record keeping meet state requirements; the successful performance of proficiency testing or alternate requirements for each test category; and a review and approval of in-house developed or non-FDA approved methods "to assure the accuracy, validity, and clinical utility of the test," BHD said.