TEST:

CancerSEEK

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."

Even if the test could detect the mutations, an extensive workup for the search of tumor is required as the assay could only detect but cannot localize the disease. Establishing the clinical validity and utility of ctDNA is imperative for its implementation in future clinical practice.

Most participants reported no change or a decrease in anxiety. This data suggest that MCED testing with imaging-based diagnostic resolution does not significantly increase anxiety or negatively impact mammography adherence for most participants, including those with FP results.

Patients with a negative PET-CT and initial clinical evaluation after a positive CancerSEEK test had low (<1% per year) risk for cancer in the ensuing four years after the initial CancerSEEK test. If confirmed, this result should prove reassuring to clinicians and to patients who have no evidence of cancer on comprehensive imaging following a positive MCED test. Further, these results provide preliminary support for the recommendation that patients who participate in MCED testing and receive a FP result can safely return to routine care after comprehensive anatomic and functional imaging and clinical evaluation reveal no suspicion of cancer.

CancerSEEK detected cancers earlier in patients who, when treated subsequently with conventional methods, achieved long-term survival. Half of all patients with a CancerSEEK-detected cancer remain cancer-free after treatment >4 years (median) after their initial CancerSEEK test. This includes 7 patients with cancer types for which no SOC screening option exists.

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"By using algorithmic inference, we showed TERT promoter may play an important role in UBC tumorigenesis."

More extensive research is required before tests based on the detection of circulating tumour cells, extracellular vesicles and cell-free RNA could reach the practice. Detection of volatile organic compounds in the human breath is a promising development; sensor technologies for this purpose could be very attractive in screening settings.

Similar results can also be observed on independent and isolated testing data. https://github.com/saifurcubd/Cancer-Detection.

Three multicancer screening tests are being validated in ongoing clinical trials, including the CancerSEEK assay, the Galleri test, and the PanSeer assay, all of which show high specificity in preliminary findings. Further validation is required before multicancer detection tests are incorporated into general population cancer screening.

Currently, less than 10% of patients diagnosed with resectable PDAC are diagnosed incidentally. Incidental diagnosis results in identification of early-stage disease and is independently associated with a significantly longer OS, thus further reinforcing the need for development screening tools that can increase the rate of diagnosis at an asymptomatic stage.