CAP Marks 10+ Years in Ensuring Quality NGS Testing

Partnering with Genomic Medical Experts, Federal Agencies Key to Advancing Precision Medicine Diagnostics

Precision medicine continues to gain momentum from the laboratory benchtop to the patient's bedside, with the CAP leading—as it has for over 10 years—in improving quality of next-generation sequencing (NGS) testing through laboratory accreditation and proficiency testing (PT) programs.

“The CAP was the first accrediting organization in the U.S. to publish accreditation requirements specific to NGS to address its emerging use in diagnostic testing,” explained CAP President Emily E. Volk, MD, FCAP, adding that over 10 years ago, the NGS requirements were published in the 2012 Edition of the CAP Molecular Pathology checklist. “Our history in ensuring clinical validity and quality of this testing, which is bolstered by our ongoing partnership with clinical organizations and federal agencies, ensures that accuracy in diagnostic testing remains central to the evolution of personalized medicine.”

These partnerships include regular discussions with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Last year, the FDA Personalized Medicine Office met monthly with the CAP to share high-level information on respective initiatives, identify potential issues, and explore ways in which the CAP and the agency can collaborate to ensure the two organizations remain aligned. The CAP is also working with the CDC to develop standards related to NGS testing.

The CAP’s clinical partners related to this area of testing include the Association of Molecular Pathology (AMP), the American College of Medical Genetics and Genomics (ACMG), and the Clinical & Laboratory Standards Institute (CLSI). One example of this partnership was to address the need for more detailed guidance for designing, developing, and administering clinical NGS tests where the CAP, with representation from AMP and collaborating with CLSI on a complimentary guideline, created structured documents, or worksheets, that translate regulatory specifications into concrete instructions that guide the user through the entire life cycle of an NGS test.

Advancing Quality Testing

A core component of the CAP’s Laboratory Quality Solutions (LQS) program, the accreditation checklist requirements provide a roadmap to operate a high-quality laboratory. Specific to NGS, these requirements address all phases of the testing process, including preanalytic, analytic, and postanalytic processes. The CAP updates its NGS checklist requirements annually based on input from experts on the CAP’s 28 scientific committees to address the expanding diagnostic uses of the method and changes in technology and science.

PT is another key CAP LQS component. CAP launched its first wet specimen NGS germline PT program in 2015; somatic solid tumor and hematologic NGS PT programs were added in 2016. In addition, the first In Silico Bioinformatics PT programs were launched in 2016 with numerous other PT programs (undiagnosed disorders for exome and trio analysis) being added over the years.

“The NGS PT programs evolve with updates to standards from other clinical organizations, as well as the CAP’s Pathology and Laboratory Quality Center for Evidence-based Guidelines,” said Dr. Volk. “Similar to our accreditation checklists, we partner with leading experts in the field of genomic medicine to enhance our PT programs. Indeed, our PT results are designed and reviewed by panels of 20-30 diverse experts specializing in genomic medicine from multiple sectors of the specialty, who are blinded to the identities of the performing laboratories.”

For more information about the CAP’s LQS program, visit CAP.org.

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, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.

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