Germline BRCA1/2 variant analysis may be considered medically necessary for individuals with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to select treatment with FDA-approved targeted therapies.
Somatic BRCA1/2 variant analysis using tumor tissue may be considered medically necessary for individuals with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to select treatment with FDA-approved targeted therapies.
All other uses of germline and somatic BRCA1/2 variant analysis to guide targeted therapy for ovarian, fallopian tube, or primary peritoneal cancer are considered investigational.
Homologous recombination deficiency (HRD) analysis of tumor tissue may be considered medically necessary for individuals with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to select treatment with FDA-approved targeted therapies.
All other uses of HRD testing of tumor tissue to guide targeted therapy for ovarian, fallopian tube, or primary peritoneal cancer are considered investigational.
BRCA1/2 variant analysis using circulating tumor DNA (liquid biopsy) may be considered medically necessary for individuals with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to select treatment with FDA-approved targeted therapies when tissue-based analysis is not clinically feasible.
All other uses of circulating tumor DNA testing (liquid biopsy) to guide targeted therapy in individuals with ovarian, fallopian tube, or primary peritoneal cancer are considered investigational.
Simultaneous testing using liquid and tumor biopsies (outside of paired or concurrent somatic-germline testing) to guide treatment in individuals with ovarian, fallopian tube, or primary peritoneal cancer is considered investigational (see Policy Guidelines).
Testing for other variants may become available between policy updates.
