An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
Practical, technological, and systemic challenges are putting pathologists in tough positions, facing competing demands for molecular analysis of limited biological samples.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
An impetus for the review included the fact that companies are advertising and promoting liquid biopsy in areas where the technology has not yet proven its clinical utility.
Researchers said that laboratories participating in BRAF proficiency testing include most of the required reporting elements "to unambiguously convey molecular results."
The recommendations were developed by a working group of the AMP Clinical Practice Committee that included representatives from ACMG, ASCO, and CAP.
The draft document, which includes recommendations on which molecular tests labs should perform, on what samples, and with what analytical specifications, is available for comment until April 22.