United States Diagnostics Standards Appoints New CEO

Christopher Singer has been named United States Diagnostics Standards’ (USDS) new CEO. USDS is an independent review body that evaluates clinical diagnostic tests, providing third-party certification and evaluation of diagnostics for pharmaceutical companies, diagnostic manufacturers, clinical laboratories, and payers.

Singer, a prominent global healthcare executive, most recently served as the chief global operating officer of United States Pharmacopeia and chief operating officer of Pharmaceutical Research and Manufacturers Association (PhRMA). At PhRMA, he helped guide the development and execution of key strategic initiatives. As a seasoned pharmaceutical executive, Singer served in a variety of key roles in both commercial operations and government relations with three prominent companies—GlaxoSmithKline (GSK), Pfizer and Bristol Myers. Earlier in his career, he served in health policy positions within the U.S. government, including with the House Appropriations Committee where he supported resource allocation for a number of federal agencies including the National Institutes of Health and the Food and Drug Administration (FDA) and the Health Care Financing Administration, helping to administer policies for the federal Medicare program. Singer holds an M.P.A. in public health administration and a B.S. in economics, both from Portland State University in Portland, Oregon.

“There is broad agreement throughout the industry on the need for trusted, third-party certification of diagnostics based on widely-respected standards,” said Singer. “USDS serves as a private, independent review body and a neutral link between the many parties involved in developing, testing, approving and paying for diagnostics. By certifying diagnostics, the company plays an essential role in ensuring quality, speeding development, easing approval and improving market acceptance of diagnostics and personalized medicine.”

The Rockville, Md.-based firm was founded in 2009 by Jeffrey Cossman, M.D., who served as USDS’ first CEO and will continue to play a central role in the company’s growth as president and chairman of the board.

“USDS brings to diagnostics what many other industries and health care sectors have: An independent, third party organization that certifies the quality of products and services,” said Cossman. “Indeed, Chris comes to USDS from one of the most respected of these certification organizations: United States Pharmacopeia. His record of leadership in building consensus across the industry—and his experience in growing and running global healthcare businesses—make him the perfect choice to lead USDS as we establish unbiased expertise and standard processes for the diagnostics industry in accordance with the best traditions of independent organizations.”

USDS certifies the performance, clinical use, and risks of diagnostic tests through its DxSTANDARDS process, using standards and methods based on the consensus of leading independent experts in medical diagnostics and clinical medicine. Analysis is conducted by experts using “gold-standard” reference sets of highly qualified clinical samples and careful study design. The company evaluates in-vitro diagnostics, companion diagnostics, and laboratory developed tests—maintaining strict neutrality and confidentiality of all activities and results. The company is recognized as a qualified independent review body for Medicare coverage in the Palmetto MolDx program—a diagnostic services program developed to identify and establish coverage and reimbursement for molecular diagnostic tests.

“Assurance of the accuracy and clinical utility of diagnostic tests by USDS fulfills a major unmet need as the role of diagnostics in healthcare expands,” said Mark McClellan, M.D., Ph.D., former commissioner of the FDA and administrator of the Centers for Medicare and Medicaid Services, who serves as a special advisor to the USDS board of directors. “USDS’ vision is to offer a standard framework to ensure the quality of new diagnostics so they can reach patients, enable personalized medicine and contribute to improved health outcomes.”