Can Grail find the trail to early cancer detection?

Fiala, Clare; Diamandis, Eleftherios P.

doi:10.1515/cclm-2018-1249

Cited by 11 publications

(5 citation statements)

References 20 publications

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“…The table demonstrates that when the mutant allele fraction drops below 0.01% (one tumor DNA molecule admixed with 10,000 normal DNA molecules), then 10 mL of blood (4 mL of plasma) will likely contain less than one cancer genome, rendering diagnosis impossible. We reached the same conclusion using other independent cancer data (not shown) and by modeling pregnancy at various gestational ages, assuming that the fetus resembles a tumor [32][33][34]. [38,39].…”

Section: Empirical Calculations Challenging the Clinical Utility Of Grail And Similar Tests For Early Cancer Diagnosissupporting

confidence: 73%

“…Here, we will provide a summary of our detailed and previously published calculations, mostly based on published empirical data, which show that ctDNA tests for the early diagnosis will likely have limited sensitivity for small, asymptomatic tumors. For more details, see our previous analyses [ 22 , 32 , 33 , 34 ].…”

Section: Empirical Calculations Challenging the Clinical Utility Of Grail And Similar Tests For Early Cancer Diagnosismentioning

confidence: 99%

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Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm

2021

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Circulating tumor DNA (ctDNA) is a new pan-cancer tumor marker with important applications for patient prognosis, monitoring progression, and assessing the success of the therapeutic response. Another important goal is an early cancer diagnosis. There is currently a debate if ctDNA can be used for early cancer detection due to the small tumor burden and low mutant allele fraction (MAF). We compare our previous calculations on the size of detectable cancers by ctDNA analysis with the latest experimental data from Grail’s clinical trial. Current ctDNA-based diagnostic methods could predictably detect tumors of sizes greater than 10–15 mm in diameter. When tumors are of this size or smaller, their MAF is about 0.01% (one tumor DNA molecule admixed with 10,000 normal DNA molecules). The use of 10 mL of blood (4 mL of plasma) will likely contain less than a complete cancer genome, thus rendering the diagnosis of cancer impossible. Grail’s new data confirm the low sensitivity for early cancer detection (<30% for Stage I–II tumors, <20% for Stage I tumors), but specificity was high at 99.5%. According to these latest data, the sensitivity of the Grail test is less than 20% in Stage I disease, casting doubt if this test could become a viable pan-cancer clinical screening tool.

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Section: Empirical Calculations Challenging the Clinical Utility Of Grail And Similar Tests For Early Cancer Diagnosissupporting

confidence: 73%

Section: Empirical Calculations Challenging the Clinical Utility Of Grail And Similar Tests For Early Cancer Diagnosismentioning

confidence: 99%

Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm

2021

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“…The results indicated that for three types of breast cancer (triple negative, HER2-positive/hormone receptor-positive and HER2-negative), the sensitivity was 58, 40 and 15%, respectively. This sensitivity shows that cfDNA liquid biopsy is still far from ready-to-use for clinic diagnosis (109). Nonetheless, since non-invasive and low-cost cfDNA testing still plays an important role in consumer-grade cancer diagnosis and cancer treatment management, such as personalized medicine and cancer prognosis.…”

Section: Resultsmentioning

confidence: 99%

Cell‑free DNA as a liquid biopsy for early detection of gastric cancer (Review)

Huang¹,

Zhang

et al. 2020

Oncol Lett

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Gastric cancer (GC) is one of the most common malignant tumors with poor prognosis worldwide, mainly due to the lack of suitable modalities for population-based screening and early detection of this disease. Therefore, novel and less invasive tests with improved clinical utility are urgently required. The remarkable advances in genomics and proteomics, along with emerging new technologies for highly sensitive detection of genetic alterations, have shown the potential to map the genomic makeup of a tumor in liquid biopsies, in order to assist with early detection and clinical management. The present review summarize the current status in the identification and development of cell-free DNA (cfDNA)-based biomarkers in GC, and also discusses their potential utility and the technical challenges in developing practical cfDNA-based liquid biopsy for early detection of GC.

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“…A company that revolutionized the cancer screening paradigm and emphasized the wide variety of cancers that can be simultaneously detected through liquid biopsy is GRAIL, a spin-off of Illumina, that received around USD 1 billion in funding for the sole goal of developing a blood test for early cancer detection [ 50 , 51 ]. For such purpose, the Circulating Cell-free Genome Atlas Study (CCGA) (NCT02889978), divided into three sub-studies, was conducted and recruited over 15000 participants with and without cancer that were longitudinally followed up.…”

Section: Multi-cancer Early Detection (Mced) Tests: State Of the Artmentioning

confidence: 99%

Shifting the Cancer Screening Paradigm: The Rising Potential of Blood-Based Multi-Cancer Early Detection Tests

Brito-Rocha

Constâncio

Henrique

et al. 2023

Cells

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Cancer remains a leading cause of death worldwide, partly owing to late detection which entails limited and often ineffective therapeutic options. Most cancers lack validated screening procedures, and the ones available disclose several drawbacks, leading to low patient compliance and unnecessary workups, adding up the costs to healthcare systems. Hence, there is a great need for innovative, accurate, and minimally invasive tools for early cancer detection. In recent years, multi-cancer early detection (MCED) tests emerged as a promising screening tool, combining molecular analysis of tumor-related markers present in body fluids with artificial intelligence to simultaneously detect a variety of cancers and further discriminate the underlying cancer type. Herein, we aim to provide a highlight of the variety of strategies currently under development concerning MCED, as well as the major factors which are preventing clinical implementation. Although MCED tests depict great potential for clinical application, large-scale clinical validation studies are still lacking.

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Can Grail find the trail to early cancer detection?

Cited by 11 publications

References 20 publications

Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm

Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm

Cell‑free DNA as a liquid biopsy for early detection of gastric cancer (Review)

Shifting the Cancer Screening Paradigm: The Rising Potential of Blood-Based Multi-Cancer Early Detection Tests

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