United States Diagnostics Standards Appoints Christopher Singer as CEO

United States Diagnostics Standards (USDS), the independent review body for medical diagnostics, today announced that it has appointed Christopher Singer to serve as CEO. Singer, a prominent global healthcare executive, most recently served as the chief global operating officer of United States Pharmacopeia (USP) and chief operating officer of Pharmaceutical Research and Manufacturers Association (PhRMA). He brings to USDS an extensive track record in building global health care businesses and at successfully leading collaborations among the health care industry, providers, policy-makers, payers and regulators.

USDS provides a trusted, standardized process for the independent evaluation of clinical diagnostic tests. The company independently evaluates diagnostics to establish clinical utility, validate quality, speed development, ensure alignment with regulatory requirements, guide regulatory pathway strategy, inform reimbursement decisions and support evidence in practice guidelines.

"I am very excited to join USDS, the independent authority to evaluate and certify medical diagnostics," said Singer. "There is broad agreement throughout the industry on the need for trusted, third-party certification of diagnostics based on widely-respected standards. 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."

USDS was founded in 2009 by Jeffrey Cossman, M.D., who served as the company's first CEO and will continue to play a central role in the company's growth as president and chairman of the board. The company raised a Series A financing in 2010, led by InterWest Partners, a venture capital firm based in Menlo Park, CA.

"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 (IVDs), companion diagnostics, and laboratory developed tests (LDTs) -- maintaining strict neutrality and confidentiality of all activities and results. USDS serves pharmaceutical companies, diagnostic manufacturers, clinical laboratories, and payers. The company is recognized as a qualified independent review body for Medicare coverage in the Palmetto MolDx program.

"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 (CMS), 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."

About Christopher Singer
Prior to joining USDS, Singer was chief global operating officer at United States Pharmacopeia (USP). Before USP, he was chief operating officer at the Pharmaceutical Research and Manufacturers of America (PhRMA) where he helped guide the development and execution of key strategic initiatives. As a seasoned pharmaceutical executive, Mr. 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 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 ec onomics, both from Portland State University in Portland, Oregon.

About USDS
United States Diagnostics Standards (USDS) is a private independent review body for medical diagnostics -- providing third-party certification and evaluation of diagnostics for pharmaceutical companies, diagnostic manufacturers, clinical laboratories, and payers. USDS provides evaluation and certification to support standardization, quality and development -- and to inform approval, reimbursement and adoption of diagnostics. The company's rigorous systems help to ensure that diagnostics serve their purpose of accurate diagnosis and patient management -- ultimately improving safety and health outcomes for patients. Founded in 2009, the company's lead investor is InterWest Partners and includes among its advisors Dr. Mark McClellan. USDS, which is privately held, is based in Rockville, Maryland. More information is available at http://www.dxstandards.com

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