Invitae Says Clinical Trial Results Support Genetic Testing Of Patients With Prostate Cancer

(RTTNews) - Invitae (NVTA) said clinical results from its PROCLAIM trial, published in European Urology Oncology, showed that almost half of prostate cancer patients with clinically actionable pathogenic/likely pathogenic germline variants or PGVs could be missing out on genetics-informed care due to restrictive criteria for genetic testing.

In the study, 51% of patients with prostate cancer met National Comprehensive Cancer Network (NCCN) guidelines and 49% did not. The diagnostic yield of germline genetic testing between these two patient groups was compared.

According to the company, offering germline testing to all prostate cancer patients could improve access to critical genetic information, particularly for historically underrepresented groups.

Real world evidence suggested that less than 15% of prostate cancer patients who could benefit from genetics-informed care undergo genetic testing, in part due to complicated and prohibitive testing guidelines.

The company found no statistically significant difference in the diagnostic yield of PGVs between those who met NCCN guidelines and those who did not, suggesting there are a significant number of patients with PGVs, many of which are targets for precision therapies, who are being missed when adhering to current NCCN guidelines for genetic testing.

The data show about 80% of men with PGVs had potentially clinically actionable variants, including those in genes with eligibility for approved precision therapies or clinical treatment trials. When stratified by self-reported ethnicity, non-white men who were out-of-criteria had a higher number of PGVs than those who were in-criteria, suggesting current criteria disproportionately disadvantage historically underrepresented populations from obtaining critical genetic information.

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