In July, the College of American Pathologists (CAP) published accreditation standards for labs performing next-generation sequencing (NGS) for clinical applications. The standards are a new addition to the molecular pathology checklist portion of CAP’s Laboratory Accreditation Program. The checklist consists of 18 requirements divided into sections for wet bench processing and bioinformatics. Among the checklist items is one addressing instrument, chemistry and reagent upgrades. Another checklist item requires documentation of sequencer error rates for variants using another sequencing method. Documentation of the entire bioinformatics process is also required, including the development of a policy on data-storage time lines. Nazneen Aziz, PhD, CAP’s director of Molecular Medicine, estimates that between 40 and 50 labs are currently using NGS for clinical testing. He expects that the checklist to be updated annually and to specifically address oncology and infectious diseases.

Source: CAP Today