INDI® RECEIVES ACCREDITATION FROM COLLEGE OF AMERICAN PATHOLOGISTS FOR SEATTLE LABORATORY;
Accreditation Reflects High Quality Standards for Laboratory Behind Xpresys ® Lung
SEATTLE, SEPTEMBER 25, 2015 – Indi (Integrated Diagnostics®) a molecular diagnostics company pioneering the use of blood-based proteomic tests, today announced the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Indi’s Seattle laboratory based on results of a recent on-site inspection.
The facility’s director, Michael J. Bauer, M.D., was advised of this national recognition and congratulated for the excellence of the services being provided. Indi’s laboratory is one of more than 7,700 CAP-accredited facilities worldwide.
Indi is the company behind Xpresys Lung, a breakthrough, molecular diagnostic blood test designed to provide physicians with an objective tool to address a major medical dilemma—the management of indeterminate lung nodules. The test is offered as a clinical laboratory developed test out of the company’s Seattle laboratory, which has also been certified by CLIA, the U.S. Clinical Laboratory Improvement Amendments, since 2013.
“Accreditation from CAP is an indication of compliance with the highest standards of laboratory practices,” said Albert A. Luderer, Ph.D., chief executive officer, Indi. “For Indi, CAP accreditation means patients, physicians and researchers can all have confidence Xpresys Lung blood tests are being conducted under the highest standards for cutting edge diagnostics. We believe we are the first laboratory conducting a multiplexed proteomic test of this complexity to receive CAP accreditation.”
The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to, or more stringent than, the government’s own inspection program.
During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.
Xpresys Lung is supported by a landmark clinical validation study published in The Journal of Thoracic Oncology in January 2015 and two studies published in Science Translational Medicine on October 2013.
Indi (Integrated Diagnostics) is redefining molecular diagnostics and creating powerful new tools for physicians to non-invasively assess and more effectively manage complex diseases to improve patient outcomes, reduce complications, and lessen costs to the healthcare system. With the company’s first breakthrough test, Xpresys Lung, which measures multiple blood proteins and identifies lung nodules with a high probability of being benign, physicians have the potential to reduce risks and the need for unnecessary invasive procedures.
The company was co-founded in October 2009 by systems-biology pioneer Dr. Lee Hood, who recently received the National Medal of Science from the U.S. government. His groundbreaking research is based on a systems biology approach, which measures hundreds of protein biomarkers found in blood to report on the physiological state of the body’s 50 major organs, such as the lungs.
Backers include Albany Capital, Alexandria Real Estate Equities, Baird Capital, CD-Venture GmbH, InterWest Partners, Life Sciences Alternative Financing and the Wellcome Trust. Foundational intellectual property is exclusively licensed from the Institute for Systems Biology and Caltech. Learn more at www.indidx.com
About the College of American Pathologists
As the leading organization with 18,000 board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP’s Laboratory Improvement Programs, initiated 65 years ago, currently has customers in more than 100 countries, accrediting 7,700 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at CAP.ORG. Follow CAP on Twitter at @PATHOLOGISTS.