"Caris Detect is completely changing the way people approach cancer screening. It means we can catch cancer earlier when it's more treatable."

1. For patients who receive a Cancer Signal Detected result, Caris offers patient reimbursement for eligible physician-ordered services related to this result throughout the diagnostic process. If insurance processes the imaging claim in any way — even if the patient has a remaining out-of-pocket balance, including copayments, coinsurance, and deductibles — those costs are not eligible for reimbursement.

2. A 99.2% specificity means that approximately 1 in 100 individuals without cancer may receive a false positive result (Cancer Signal Detected). 99.2% specificity was established in a case-control validation study comparing samples from patients with known cancer to non-cancer controls. No prospective randomized controlled trials have yet evaluated Caris Detect's specificity in a general screening population.

3. Caris Life Sciences' molecular profiling platform has processed over 1 million tumor cases and 50 billion molecular markers. The AI model used specifically for multi-cancer early detection (MCED) in Caris Detect was trained on 2243 patients and validated on an independent blinded test set of 776 patients.

4. A Cancer Signal Not Detected result does not rule out cancer entirely. Caris Detect is intended to supplement, not replace, standard cancer screenings. Individuals should continue to get regular mammograms, colonoscopies, and other routine screenings based on individual risk factors.

5. Reference: Abraham J, Domenyuk V, Perdigones N, Klimov S, Antani S, Yoshino T, Heath EI, Lou E, Liu SV, Marshall JL, El-Deiry WS, Shields AF, Dietrich MF, Nakamura Y, Fujisawa T, Demetri GD, Barker A, Xiu J, Sacchetti DA, Stahl S, Hahn-Lowry R, Stark A, Swensen J, Poste G, Halbert DD, Oberley M, Radovich M, Sledge GW, Spetzler DB. Validation of an AI-enabled exome/transcriptome liquid biopsy platform for early detection, MRD, disease monitoring, and therapy selection for solid tumors. Sci Rep. 2025 Jul 1;15(1):21173. doi: 10.1038/s41598-025-08986-0. PMID: 40596693; PMCID: PMC12214926.

Caris Detect looks for signals across a range of cancer types. Detection performance varies by cancer type and stage and has not been established for every type listed.

This test was developed and its performance characteristics determined by Caris Life Sciences. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary for laboratory developed tests (LDT). This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical laboratory testing.

Caris Detect is a laboratory-developed test (LDT) performed in a CLIA-certified, CAP-accredited laboratory. It is a blood based next-generation sequencing assay that uses whole genome sequencing of circulating cell-free DNA (cfDNA) and bioinformatic analysis to detect genomic patterns associated with cancer.

Caris Detect is intended for use as a screening aid in asymptomatic adults at increased risk for cancer (due to age, cancer predisposition, exposure history, etc.), with no prior history of cancer within the last 3 years, to identify individuals who may warrant additional clinical evaluation.

Caris Detect is not intended to diagnose cancer. A positive result should be followed by confirmatory diagnostic evaluation (e.g., imaging and tissue-based diagnosis) consistent with standard clinical practice. A negative result does not rule out cancer. The test does not detect all cancers, and false positives and false negative results may occur.

Caris Detect should not replace guideline-recommended cancer screening tests and is intended to be used in addition to standard screening recommendations.

Caris Detect is intended for use in adults 21 years of age and older who meet the clinical criteria.

The test is not intended for use in individuals who:

• Are under 21 years of age

• Are currently pregnant or within 1 month postpartum, including following miscarriage

• Have a current or prior cancer diagnosis within the last 3 years

• Are undergoing active cancer treatment

• Have received an allogeneic (donor) bone marrow or stem cell transplant. If autologous (self), it must be 6 months post-transplant to qualify.

• Have received an organ transplant at any time

Caris Detect results should be interpreted by a qualified healthcare provider in the context of the patient's clinical history and other diagnostic findings.

This test was developed and its performance characteristics determined by Caris Life Sciences. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary for clinical use of this test as a laboratory-developed test.