CAP

The new guidelines said ROS1, KRAS, BRAF, MET, RET, and HER2 should be included in targeted and expanded panels.

The similar analytic performance of LDTs and FDA-approved tests informs the ongoing debate about the regulation of in vitro testing.

The workgroup wanted to address the problem of variability in how bioinformatics pipelines are validated in order to improve the accuracy of NGS tests.

 The registry, which has been approved by CMS, is designed to demonstrate quality pathology practices and maximize reimbursements.

Several commercial NIPT providers in the US said they are planning to participate in the new program.

According to a presentation at the College of American Pathologists' annual meeting, around 62 percent of lab testing errors occur during the preanalytical phase. 

With only one test FDA-approved for primary hrHPV screening, groups express concern about feasibility of moving away from co-testing

Researchers said that laboratories participating in BRAF proficiency testing include most of the required reporting elements "to unambiguously convey molecular results." 

The groups said they hope their recommendations lead to higher-quality sequencing results in the lab and better care for cancer patients in the clinic.

The guidance includes recommendations for extended RAS mutation testing to guide anti-EGFR therapy, as well as updated endorsements for analysis of mismatch repair status.

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