Peer-reviewed study in the Journal of the National Comprehensive Cancer Network describes the CARE program’s utility as digital risk assessment tool validated with real-world patient data
Ambry Genetics, now a wholly owned subsidiary of Tempus AI company and a leader in clinical genomic testing, announced that a peer-reviewed study validating the accuracy of the Ambry CARE Program for hereditary cancer risk assessment has been published in the Journal of the National Comprehensive Cancer Network. The study, “Validation of a Digital Tool that Uses National Testing Guidelines to Identify Individuals at Risk for Hereditary Cancer,” demonstrated that the CARE program accurately interprets NCCN Clinical Practice Guidelines in Oncology with 99.5% accuracy, reinforcing its effectiveness as a digital risk assessment tool for identifying patients who may benefit from hereditary cancer-focused genetic testing and personalized care.
Approximately 5% of individuals have a mutation in a cancer predisposition gene, yet most are unaware. NCCN Guidelines are a trusted source for hereditary cancer testing criteria, but their complexity and frequent updates may make them difficult for non-specialist clinicians and digital health tools to apply effectively. CARE addresses this gap by streamlining the hereditary cancer risk assessment process.
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“The validation of CARE’s accuracy reinforces what we’ve experienced at HCA Healthcare’s Sarah Cannon Cancer Network – that, in addition to being well received by our patients, CARE’s assessment can reliably identify patients who need genetic services,” said Dr. Dax Kurbegov, Vice President and Physician-In-Chief of Clinical Programs, HCA Healthcare’s Sarah Cannon Cancer Network. “With demonstrated 99.5% accuracy in applying clinical guidelines, we can confidently scale hereditary cancer risk assessment across our community hospitals, ensuring more patients have access to potentially life-saving genetic insights.”
The Ambry CARE Program® leverages digital health solutions to enable health systems to stratify patients by cancer risks, driving personalized, proactive care. Its HIPAA-compliant application integrates with electronic health records and collects medical and family history directly from patients via a mobile-friendly assessment prior to in-person visits. The program weighs these data against guidelines to identify those who qualify for hereditary cancer testing and/or increased breast cancer screening based on estimated breast cancer risk. This enables clinicians to make timely, evidenced-based medical decisions, while offering patients education and connection to third-party genetic counseling at no additional cost.
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The newly published study assessed CARE’s accuracy by using the program to identify cases that met hereditary cancer testing criteria based on NCCN Guidelines for hereditary breast, ovarian, pancreatic, and prostate cancer, as well as for Lynch syndrome and familial adenomatous polyposis1,2. Researchers then compared CARE’s results against those of certified genetic counselors reviewing the same cases, confirming its ability to accurately identify 398 out of 400 real-world patient cases.
“CARE offers healthcare systems a quality, end-to-end solution that transforms how they identify the need for, implement, and scale genetic testing,” added Tom Schoenherr, CEO of Ambry Genetics. “Because clinicians can trust CARE’s comprehensive history collection and accurate risk assessment, they can feel confident expanding access to genetic services, improving outcomes for more patients, and making genetic testing a seamless part of their patient care and population health strategies.”
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate. V2.2025. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric. V3.2024. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- Caswell-Jin JL, Zimmer AD, Stedden W, Kingham KE, Zhou AY, Kurian AW. Cascade genetic testing of relatives for hereditary cancer risk: results of an online initiative. J Natl Cancer Inst. 2019;111(1):95-98. doi:10.1093/jnci/djy147
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Source – businesswire
