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NAVIGATE BIOPHARMA SERVICES, INC EARNS ACCREDITATION TO ISO 15189:2012 FROM CAP

Navigate BioPharma Services, Inc. provides a broad portfolio of assays utilizing state of the art, diverse technologies that can address clinical biomarker and precision medicine testing needs for every phase of clinical trials (first-in-human through global Phase III pivotal studies). Our integrated solutions address specific clinical trial objectives including biomarker identification, pharmacodynamics, safety and efficacy readouts, patient inclusion, disease diagnosis and prognosis. (PRNewsfoto/Navigate BioPharma Services, Inc.)

News provided by

Navigate BioPharma Services, Inc.

Oct 31, 2024, 09:05 ET

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NORTHFIELD, Ill., Oct. 31, 2024 /PRNewswire/ -- The College of American Pathologists (CAP), a Centers for Medicare and Medicaid Services (CMS)-approved accreditation authority, has awarded Navigate BioPharma Services, Inc. accreditation to the ISO15189 standard under the CAP 15189SM Accreditation Program. 

The accreditation is based on the International Organization for Standardization (ISO) 15189 Standard for laboratories' technical competence, management, and continual improvement. It focuses on improved patient safety and risk reduction, outlining standards for quality, and competence particular to medical laboratories. 

CAP 15189SM is a voluntary, non-regulatory accreditation to the ISO 15189:2012 Standard as published by ISO. The program does not replace the CAP's Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program but complements CAP accreditation and other quality systems. The program optimizes processes to improve patient care, strengthens quality standards while reducing institutional errors and risks, and controls costs. CAP 15189SM is an educational program that offers a highly disciplined approach to implementing and sustaining change.

"The ISO 15189 standard helps laboratories achieve a framework to continuously work on improving themselves," said Vipul Trivedi, MD FCAP and Chair of the CAP 15189 Committee. "Through the use of risk assessment and process improvement, we are able to achieve the highest levels of laboratory care for patients."

"This accreditation underscores our commitment to the highest standards of quality and patient care," said Shannon Sykes, Head of Quality at Navigate BioPharma Services, Inc. "Achieving ISO 15189:2012 accreditation demonstrates our dedication to continuous improvement and excellence in laboratory services."

For additional information on the CAP 15189SM Program, e-mail [email protected].                 

About the College of American Pathologists
As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, 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. For more information, read the CAP annual report at CAP.ORG

About Navigate BioPharma Services, Inc.
Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development and companion diagnostic applications. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. The company has a proven track record of success in developing and validating assays for a wide range of therapeutic and diagnostic applications. Their extensive expertise offers high-quality, accurate, and reliable solutions for its customers and partners to make informed decisions about drug development and patient care. For more information about Navigate BioPharma's services, please visit www.navigatebp.com or connect with them on LinkedIn at www.linkedin.com/company/navigatebp/.

  • Media and Customer Contact information: To learn how Navigate may be able to support your organization with an upcoming clinical trial study contact: Nick Sanna, Head of Business Development & Strategic Alliances, Navigate BioPharma Services, Inc. Phone: (760) 602-1409. Email: [email protected].

Contact: 

Joe Schramm


800-323-4040, ext. 7445      

SOURCE Navigate BioPharma Services, Inc.

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