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4ms
Understanding the Landscape of Multi-Cancer Detection Tests: The Current Data and Clinical Considerations. (PubMed, Life (Basel))
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.
Journal • Review
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CancerSEEK
5ms
Outcomes Following a False-Positive Multi-Cancer Early Detection Test: Results from DETECT-A, the First Large, Prospective, Interventional MCED Study. (PubMed, Cancer Prev Res (Phila))
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.
Journal
|
CancerSEEK
6ms
Multi-year clinical outcomes of cancers diagnosed following detection by a blood-based multi-cancer early detection (MCED) test. (PubMed)
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.
Journal • Clinical data
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CancerSEEK
6ms
Reimagining Colorectal Cancer Screening: Innovations and Challenges with Dr. Aasma Shaukat. (PubMed, Cancers (Basel))
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.
Journal
|
CancerSEEK
7ms
Outcomes following a false positive multi-cancer early detection (MCED) test: Results from DETECT-A, the first large, prospective, interventional MCED study. (PubMed, Cancer Prev Res (Phila))
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.
Journal
|
CancerSEEK
9ms
Case report: DETECT-A participants with pre-malignant conditions (AACR 2024)
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.
Clinical • Case report
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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TP53 mutation • KRAS mutation • PIK3CA mutation
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CancerSEEK
1year
Circulating tumor DNA (ctDNA): can it be used as a pan-cancer early detection test? (PubMed, Crit Rev Clin Lab Sci)
"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."
Journal • Review • Pan tumor • Circulating tumor DNA
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CancerSEEK • Galleri Test
1year
Exploring Circulating Tumor DNA (CtDNA) and Its Role in Early Detection of Cancer: A Systematic Review. (PubMed)
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.
Journal • Review • Circulating tumor DNA
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CancerSEEK
over1year
Participant perceptions and mammography adherence from DETECT-A: The first prospective interventional trial of a multi-cancer early detection (MCED) blood test (ESMO 2023)
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.
Clinical • Adherence
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CancerSEEK
over1year
Outcomes in participants with a false positive multi-cancer early detection (MCED) test: Results from >4 years follow-up from DETECT-A, the first large, prospective, interventional MCED study. (ASCO 2023)
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.
Clinical
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CancerSEEK
over1year
Long-term clinical outcomes of cancers diagnosed following detection by a blood-based multi-cancer early detection (MCED) test. (ASCO 2023)
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.
Clinical data • Clinical
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CancerSEEK
almost3years
CancerSEEK US regulatory estimate: Approval for detection of cancer types in H2 2022 (Oppenheimer)
A subscription to REFINITIV is required to access document 95201477 | Page no: 02 | REPORT TITLE: "Quick take on Cologuard 2.0 update: Specificity improvement is clinically relevant” | AUTHOR: Kevin M. DeGeeter, et al | DATE: 01/18/22
FDA event
|
CancerSEEK
almost3years
CancerSEEK US regulatory estimate: Approval for detect multiple types of cancer in H2 2022 (Oppenheimer)
A subscription to REFINITIV is required to access document 95089052 | Page no: 02 | REPORT TITLE: "Pre-Announces 4Q21 Beat; We are cautious on 1Q22 screening outlook” | AUTHOR: | DATE: 01/09/22
Regulatory
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CancerSEEK
over3years
TERT promoter mutation in genomic evolution of urothelial bladder cancer: phylogenetic tree model by algorithmic inference from cross-sectional data (AUA 2021)
"By using algorithmic inference, we showed TERT promoter may play an important role in UBC tumorigenesis."
TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR3 (Fibroblast growth factor receptor 3) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase) • KMT2D (Lysine Methyltransferase 2D) • KDM6A (Lysine Demethylase 6A)
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TP53 mutation • PIK3CA mutation • ARID1A mutation • TERT mutation • TERT promoter mutation
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CancerSEEK • UroSEEK
over3years
Early detection of gastric cancer beyond endoscopy - new methods. (PubMed, Best Pract Res Clin Gastroenterol)
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.
Journal • Review
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CancerSEEK
almost4years
CancerEMC: frontline non-invasive cancer screening from circulating protein biomarkers and mutations in cell-free DNA. (PubMed, Bioinformatics)
Similar results can also be observed on independent and isolated testing data. https://github.com/saifurcubd/Cancer-Detection.
Journal
|
CancerSEEK
4years
Novel blood-based early cancer detection: diagnostics in development. (PubMed, Am J Manag Care)
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.
Journal
|
CancerSEEK • Galleri Test
4years
[VIRTUAL] INCIDENTAL DIAGNOSIS OF ASYMPTOMATIC PANCREATIC DUCTAL ADENOCARCINOMA IS ASSOCIATED WITH IMPROVED PATIENT OUTCOMES – CLINICAL APPLICATION OF CANCERSEEK (APCM 2020)
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.
Clinical
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CA 19-9 (Cancer antigen 19-9)
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CancerSEEK