The whole-genome test combines data from 7 million genetic markers with clinical risk factors to provide individualized 10-year and lifetime risk assessments.
MyOme has launched its Prostate Cancer Integrated Polygenic Risk Score (iPRS) test, designed to identify men at elevated genetic risk for prostate cancer beyond traditional screening methods.
The clinical whole-genome testing combines data from approximately 7 million genetic markers with established clinical risk factors to provide individualized 10-year and lifetime risk assessments. According to the National Cancer Institute, approximately 60% of prostate cancer risk is driven by heritable factors, many of which can now be identified through advanced genomic modeling.
While a small proportion of men carry variants in single genes known to increase prostate cancer risk, such as BRCA2 or HOXB13, up to 95% of prostate cancer cases occur in men without a known single gene variant but who may still harbor polygenic risk detectable by the iPRS test.
“The Prostate Cancer iPRS test elevates risk assessment in men’s health,” says Dr Akash Kumar, co-founder of MyOme, in a release. “By integrating genome sequencing with clinical risk factors, we can more precisely identify men at substantially increased risk and enable earlier screening and prevention strategies to ultimately improve outcomes.”
Clinical Validation Data
The test was validated across more than 140,000 middle-aged and older men (40-75) from ancestrally diverse cohorts, demonstrating cross-ancestry performance and equitable risk prediction, according to the company.
In MyOme’s internal validation, 8.6% of men with no family history were identified as high risk by iPRS and had a threefold higher incidence of prostate cancer compared to the non-risk group.
A meta-analysis involving over 520,000 men showed those in the top decile of polygenic risk scores had a 3-4× higher risk of developing prostate cancer than average-risk men.
In the BARCODE1 trial, published in the New England Journal of Medicine, men in the top 10% of a prostate cancer polygenic risk score underwent MRI and biopsy regardless of PSA level. Among them, 40% were diagnosed with prostate cancer, and 55% of those cancers were clinically significant. Notably, 72% of these high-risk cases would have been missed by traditional PSA/MRI screening.
Addressing PSA Limitations
Current prostate cancer screening relies heavily on PSA testing, which has well-known specificity challenges. Up to three-quarters of elevated PSA results are false positives, leading to unnecessary imaging, biopsies, and patient anxiety.
The iPRS test aims to provide additional evidence-based tools that can more accurately stratify risk and support shared decision-making conversations between physicians and patients.
Test Availability and Requirements
The Prostate Cancer iPRS test is available for men aged 30-75 years who have no personal history of prostate cancer and no pathogenic variants in known prostate cancer-associated genes such as BRCA1, BRCA2, or HOXB13.
Results are delivered through MyOme’s secure portal and should be interpreted by a clinician in the context of clinical and family history, with genetic counseling available as needed.
MyOme is certified under the Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists. The company is headquartered in Menlo Park, California.
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