Ambry Genetics' CARE Program Validated for Accuracy in Identifying High-Risk Patients for Hereditary Cancer Testing

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, Inc. (NASDAQ:TEM) company and a leader in clinical genomic testing, announced today that a peer-reviewed study validating the accuracy of the Ambry CARE Program® (CARE) 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 (NCCN Guidelines®)^1,2 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.³ 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.

"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.

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 polyposis^1,2. 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."

1. 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.
2. 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.
3. 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

ABOUT AMBRY GENETICS®

Ambry Genetics translates scientific research into clinically actionable test results based upon a deep understanding of the human genome and the biology behind genetic disease. It is a leader in genetic testing that aims to improve health by understanding the relationship between genetics and disease. Its unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate, and pharmaceutical partners, means Ambry Genetics is first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions.

ABOUT TEMPUS

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world's largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus' industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential impact of Ambry Genetic's research and publications; the contributions of Ambry Genetic's research and findings to the larger scientific community and the use of its products and services to advance clinical care for patients are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "going to," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

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