Boston Heart Diagnostics has announced that the company can serve patients from all 50 states now that it has successfully completed the New York State Department of Health (NYSDOH) clinical laboratory permitting process.
Boston Heart president and CEO Susan Hertzberg noted that this is another critical milestone for the company as it works to fulfill our mission of enabling patients to prevent disease and improve overall heart health.
"Cardiovascular disease (CVD) is complex, so we have assembled a focused test menu addressing the key areas of CVD risk including: lipids, metabolics, inflammation and genetics. Lifestyle choices are paramount to preventing and reversing CVD and we can use each person’s test results to create a personalized nutrition plan to help with those choices. There’s a significant unmet need in New York State. We’re delighted that New Yorkers can now have access to the full complement of next-generation diagnostics and individualized patient reports that Boston Heart offers," Hertzberg added.
Requirements for a New York State permit include certification of a director and/or assistant directors for each test category; an on-site inspection to ensure that the premises, laboratory practices, equipment, personnel and record-keeping meet the state’s exacting requirements; successful performance of proficiency testing or alternate requirements for each test category; and review and approval of any in-house developed or non-FDA approved methods to assure the accuracy, validity, and clinical utility of the test.