Accreditation Supports Company’s Global Expansion Strategy
LOS ANGELES, September 8, 2015 – Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized medicine for all cancer patients, today announced that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to its laboratory. Cynvenio has been certified by CLIA, the U.S. Clinical Laboratory Improvement Amendments, since 2013.
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.
André de Fusco, Cynvenio’s CEO commented: “Our ClearID™ sequencing tests for breast, prostate and colorectal cancer have been available to international customers and oncology researchers since 2013, in part because our patient sample kits are practical and travel unrefrigerated to our processing center, and because we deliver genomic results in a week from a standard blood draw. The 2015 CAP accreditation gives our international partners visibility into Cynvenio’s licensure in support of our international lab service strategy, particularly in Asia and Europe.”
With both the CAP accreditation and CLIA certification, customers around the world can more confidently order Cynvenio’s fast-start lab services to support clinical utility studies and LiquidBiopsy® sequencing programs, which they can later migrate in-house should they wish to do so. The LiquidBiopsy instrumentation and consumables can also be purchased globally through Cynvenio’s partnership with Thermo Fisher Scientific.
More information is available at www.cynvenio.com.
About the College of American Pathologists
The College of American Pathologists (CAP), celebrating 50 years as the gold standard in laboratory accreditation, is a medical society that serves more than 18,000 physician members and the global laboratory community. It is the world’s largest association composed exclusively of board-certified pathologists and is the worldwide leader in laboratory quality assurance. The College advocates accountable, high-quality, and cost-effective patient care. More information about the CAP can be found at www.cap.org.
About Cynvenio Biosystems, Inc.
Cynvenio is a commercial stage clinical diagnostics company that leverages its proprietary LiquidBiopsy® multi-template technology for the molecular characterization of tumor cells from a standard blood draw. Commercial labs and research institutions are powered by Cynvenio’s LiquidBiopsy platform, which includes automated instrumentation, consumables/reagents, patient sample kits, and bioinformatics for sequencing rare cell populations. Oncology practices and individual physicians can also access the LiquidBiopsy system with zero upfront investment by ordering the ClearID™ blood test from Cynvenio’s CLIA/CAP lab or its clinical partners. ClearID and LiquidBiopsy are cornerstones in the emerging field of genomic peripheral blood monitoring. They are used to rapidly assess patients’ evolving mutations in support of precision medicine strategies. ClearID is reimbursable in the United States.
LiquidBiopsy® and ClearID™ are trademarks of Cynvenio Biosystems, Inc.