Imagine detecting more 
cancers — early

Multi-cancer early detection (MCED) testing is designed to complement current standard screening methods, with the goal of taking cancer detection beyond what’s possible with single-cancer screenings.1

Exact Sciences is developing an MCED test designed to be used alongside standard-of-care-screening, with the goal to help close gaps in cancer screening.

Multiple studies we have conducted demonstrate the potential to deliver impactful results. Our study goals included:

 

 

Designing a multi-biomarker class (mutations, methylation, proteins, and aneuploidy) and machine-learning approach to help enable earlier cancer detection

Detecting cancers in multiple organs, including those with no recommended screening options

Delivering high early-stage sensitivity (Stage I and II), enabling the possibility to detect cancer early, when it is more treatable

Providing high specificity in detecting cancer, helping to minimize false positive results

Developing an efficient path to diagnostic resolution for patients and providers

Developing a single blood test for multi-cancer screening

Advances in cancer research have demonstrated that several tumor markers common to multiple cancers are released into the bloodstream by cancer cells. As the visionary culmination of many key discoveries in cancer biology, MCED tests are designed to detect signals from many types of cancer, including those with no recommended screenings, in early, more treatable stages. We are developing an MCED test to offer screening for multiple cancers with a simple and minimally invasive blood collection.2-6

Breaking new ground in cancer screening

Researchers at premier institutions like Johns Hopkins University and the Mayo Clinic have led the way in the development of MCED testing as a new paradigm in cancer screening. Through decades of effort, scientists at Johns Hopkins University innovatively built upon the discoveries they made to create the CancerSEEK test, a precursor to the MCED test in development by Exact Sciences. As a continuation of this groundbreaking work, we have conducted various studies focused on establishing the performance of our MCED test in development:3,6-8

2016
Development of the MCED test, CancerSEEK begins
2018
Published Cohen proof-of-concept study7
2018
Received FDA designation of the CancerSEEK test as Breakthrough Device
2020
DETECT-A study results published showing the CancerSEEK MCED test doubled the number of screen-detected cancers and detected cancers with no recommended screening3
2020
Published Douville et al. study showcasing the ability to improve sensitivity of MCED tests by combining mutations, proteins, and aneuploidy8
2021
Results from Katerov et al. demonstrated that an assay of select methylated DNA markers and proteins could detect multiple cancers, including in early stages9
2022
Shared results from Allawi et al. showing that a combination of DNA methylation and protein markers delivered high sensitivity across multiple cancer types while maintaining high specificity10
2022
Presented PRE-ASCEND clinical feasibility and development data at the American Association for Cancer Research Special Conference demonstrating the ability of a four-biomarker class test design to improve early-stage sensitivity while maintaining strong specificity11
2023
Ongoing work for biomarker selection finalization for our MCED test in development

DETECT-A was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting.3

 

The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study enrolled more than 10,000 women with no history of cancer to determine if a blood test in combination with standard-of-care screenings could detect cancers before signs and symptoms appeared. The CancerSEEK test, the MCED test studied in DETECT-A, is a forerunner of the MCED test currently in development.3 

In DETECT-A, the CancerSEEK test doubled the number of cases first detected by standard-of-care

The majority of cases (62%) found were early (stage I-II) or regional disease (stage III)

*17 of 26 cancers first detected by blood testing were classified as localized or regional disease with one of unknown stage.

High-specificity by design

While single-organ cancer screenings prioritize high sensitivity to confirm the absence of a single cancer type, MCED tests are intentionally designed to prioritize high specificity to indicate the presence of any of the multiple cancer types it screens for while minimizing false positive results.3,6

Exact Sciences’ MCED test is being designed based on four distinct biomarker classes found in the blood to help enable earlier cancer detection.6

Methylation
Aneuploidy
Mutations
Protein markers

Aiming for a clear path after test results

 

In the DETECT-A study, MCED testing in combination with imaging (radiology) scans provided an efficient path to diagnostic resolution. A positive test was followed by imaging scans to localize and confirm the presence of cancer.3 

 

Based on findings from DETECT-A, Exact Sciences’ MCED test is being developed to offer an efficient path forward after a positive test through proposed imaging workups.3
Learn more about our MCED test under development
View additional resources and information

Frequently Asked Questions

Exact Sciences’ MCED test is under development. The features above describe current development goals. It has not been cleared or approved by the US Food and Drug Administration or any other national regulatory authority.

 


 

References

  1. Beer TM. Am J Manag Care. 2021;27(19 Suppl):S347-S355.
  2. Ahlquist DA. NPJ Precis Oncol. 2018;2:23.
  3. Lennon AM, Buchanan AH, Kinde I, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020;369(6499).
  4. United States Preventive Services Task Force. A and B recommendations. Published 2022. Accessed November 17, 2022.  https://uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-and-b-recommendations
  5. PDQ Screening and Prevention Editorial Board. Cancer Screening Overview (PDQ®). In: PDQ Cancer Information Summaries [Internet]. National Cancer Institute; updated June 29, 2021. https://www.ncbi.nlm.nih.gov/books/NBK65793/
  6. Douville C, et al. Poster presented at: ESMO Congress; September 9-13, 2022; Paris, France. Abstract 73P
  7. Cohen JD, et al. Science. 2018;359(6378):926-930.
  8. Douville C, et al. Proc Natl Acad Sci USA. 2020;117(9):4858-4863.
  9. Katerov S, et al. Presented at: American Association for Cancer Research Annual Meeting 2021; April 10-15 and May 17-21, 2021; Philadelphia, PA. Abstract 111
  10. Allawi HT, et al. Presented at: American Association for Cancer Research Annual Meeting 2022; April 8-13, 2022; New Orleans, LA. Abstract 631
  11. Gainullin V, et al. Presented at AACR Special Conference: Precision, Prevention, Early Detection, and Interception of Cancer 2022; November 17-19; Austin, TX. Abstract P041

  12. Siegel RL, et al. CA Cancer J Clin. 2022;72:7-33.