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  4. CAP Molecular Proficiency Testing Programs Demonstrate Accurate Clinical Cancer Sequencing Results

Molecular testing laboratories using CAP proficiency testing (PT) programs exhibit excellent testing performance based on a recent reanalysis of a pilot study that was published in the Archives of Pathology & Laboratory Medicine.

As a result of a recent reanalysis of The Sustainable Predictive Oncology Therapeutics and Diagnostic (SPOT/Dx) quality assurance pilot study results on molecular oncology next generation sequencing (NGS), the CAP Molecular Oncology Committee concluded that these pilot results should not be extrapolated to all molecular oncology testing and should not be used to market products or change policy affecting all molecular oncology testing.

The initial SPOT/Dx pilot study was based on a limited set of rare to never observed mutations at low frequencies and during a limited time period several years ago. Given the robust evidence of strong testing performance in clinical laboratories using CAP proficiency testing (PT) programs, there is no additional benefit for third party proof of performance of molecular testing in these laboratories. The CAP PT data are among the highest quality, demonstrating excellence in laboratory performance across the over 23,000 laboratories around the world that participate in this program. Read more.

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