TEST:

CancerSEEK

"Caris Life Sciences®...has published a study in Oncotarget validating the analytical and clinical performance of MI Cancer Seek®. This FDA-approved assay is used as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted therapies. It includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology."

By overcoming these gaps, AI-powered epigenetic diagnostics can enable earlier detection, more effective treatments, and improved patient outcomes, globally. In summary, this review synthesizes current advancements in the field and envisions a future where AI and epigenomics converge to redefine cancer diagnostics and therapy.

2. See the NIHR Funding and Awards website for further award information.

Additionally, this review points to future directions in PC diagnostics, including next-generation imaging, molecular biomarkers, and personalized medicine, aiming to overcome current diagnostic challenges and improve survival rates. Ultimately, the review advocates the adoption of informatics and AI-driven strategies to enhance early detection, reduce morbidity, and save lives in the fight against pancreatic cancer.

In the CRC CancerSEEK dataset, we report 14% improvement in sensitivity at 98.5% specificity (0.31 vs 0.57; p-value:<0.05). The SMAGS method provides an alternative to logistic regression for modeling combination rules for biomarkers and early detection applications.

Ongoing trials continue to assess the efficacy, safety, and cost implications of MCD tests. In this review, we discuss the performance of CancerSEEK and Galleri, two leading MCD platforms, and discuss the clinical consideration for the broader application of this new technology.

Prevention Relevance: This study provides multiyear clinical outcomes data following a false-positive multi-cancer early detection test for individuals participating in a prospective interventional trial. It provides a preliminary performance assessment of an imaging-based diagnostic workflow following a false-positive multi-cancer early detection test.

Most were diagnosed with early-stage cancers and were treated surgically. These results suggest that early cancer detection by CancerSEEK may have facilitated curative-intent treatments and associated positive clinical outcomes in some DETECT-A participants.

Lowering screening age along with the integration of blood-based tests with existing screening methods holds great potential in reducing the CRC-related burden. At the same time, it is increasingly important to address the challenges of adaptation of the healthcare system to this change in the epidemiologic paradigm.

The annual incidence rate of cancer during follow-up from FP determination was 1.0% (95% CI: 0.2%-2.8%). Participants with a positive CancerSEEK test who underwent 18-F-FDG PET-CT and clinical workup without cancer findings had low risk for cancer over the following several years.

The diagnostic evaluation of a positive MCED test may occasionally reveal clinically significant pre-cancerous conditions amenable to interventions. The frequency of such findings and their clinical impact warrants further study.

"To demonstrate clinical utility in an asymptomatic population, these tests must be shown to reduce cancer mortality without causing excessive overdiagnosis in a large randomized prospective randomized trial. Such trials are currently ongoing for Galleri and CancerSEEK."