Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 01

73P - Multi-cancer early detection through evaluation of aneuploidy, methylation, and protein biomarkers in plasma

Date

10 Sep 2022

Session

Poster session 01

Topics

Cancer Diagnostics

Tumour Site

Presenters

Christopher Douville

Citation

Annals of Oncology (2022) 33 (suppl_7): S27-S54. 10.1016/annonc/annonc1037

Authors

C. Douville1, C. Nobles2, H.J. Hwang2, V.E. Katerov2, V. Gainullin2, J. Tong2, K. Ushakov2, A. Koenig2, H. Guttman2, M. Jaime2, J. Wang2, W. Ault2, M.M. Gray2, G.C. Cerqueira2, C. Lengauer2, J. Garces2, A. McElhinny2, H.T. Allawi2, F. Diehl2

Author affiliations

  • 1 School Of Medicine, Johns Hopkins University, 21231 - Baltimore/US
  • 2 Research & Development, Exact Sciences Corporation, 53719 - Madison/US
More

Abstract 73P

Background

Multi-cancer early detection (MCED) using a blood test represents a rapidly emerging, potentially transformative advance in preventive oncology. Given the complexity of carcinogenesis across organs, simultaneous analysis of several biomarkers will maximize assay performance, particularly for early stage tumors.

Methods

Previously, we demonstrated the performance of blood tests that incorporated the detection of DNA mutations plus proteins and combining DNA methylation and proteins, respectively. In the current study, we assessed the combination of aneuploidy, DNA methylation, and proteins. To assess aneuploidy, we used the Repetitive Element AneupLoidy Sequencing System (REALSeqS). In addition, we explored in silico sequencing features from REALSeqS beyond aneuploidy to increase detection sensitivities. DNA methylation testing was performed on a refined panel of markers using the Target Enrichment Long-probe Quantitative Amplified Signal (TELQAS) assay on bisulfite converted cell-free DNA. For protein quantification we applied an immunoassay to quantify six extensively documented biomarkers.

Results

To assess the performance of these biomarkers, we designed a retrospectively-assembled, case-control study consisting of 600 cancers (12 organ types, all stages) and 1,920 non-cancers. From the total samples, 2,386 have been analyzed for all biomarkers. Using a stratified 5-fold cross-validation, we found that the combined markers can detect cancer across all 12 organ types and stages with a mean overall sensitivity of 52.6% (95% CI: 47.0%-58.2%) at mean specificity of 98.7% (95% CI: 98.3%-99.2%). By stage the following sensitivities were determined: Stage I/II: 32.8%, Stage III 59.9%, and stage IV 87.7%. The cancer-specific sensitivities were lowest for prostate and kidney cancers and highest for liver and ovarian cancers.

Conclusions

In summary, these three biomarker classes provide complementary and highly specific components for a multi-cancer early detection test. When combining a diverse set of analytes, we believe that a single blood test has the potential to effectively detect a large number of cancer types, particularly in earlier stage disease.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Exact Sciences.

Funding

Exact Sciences.

Disclosure

C. Douville: Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation; Financial Interests, Institutional, Other, independent consultant: Exact Sciences Corporation; Financial Interests, Institutional, Full or part-time Employment: Johns Hopkins University School of Medicine. C. Nobles: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. H.J. Hwang: Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation; Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation. V.E. Katerov: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. V. Gainullin: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. J. Tong: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. K. Ushakov: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. A. Koenig: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. H. Guttman: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. M. Jaime: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. J. Wang: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. W. Ault: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. M.M. Gray: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. G.C. Cerqueira: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. C. Lengauer: Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. J. Garces: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. A. McElhinny: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. H.T. Allawi: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Institutional, Stocks/Shares: Exact Sciences Corporation. F. Diehl: Financial Interests, Institutional, Full or part-time Employment: Exact Sciences; Financial Interests, Institutional, Stocks/Shares: Exact Sciences.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.