Cancerguard™ / Our Expertise

Our expertise in cancer screening

Our mission at Exact Sciences is to eradicate cancer and the suffering it causes—through tests that help prevent it, detection that finds it earlier, and guidance for its successful treatment.

CLOSING THE SCREENING GAPS

As the second leading cause of death in the United States, cancer is one of the greatest enemies in public health today.1

~600,000

people die due to cancer each year1

ONLY 1/3

of diagnosed cancers have recommended screening options2*

MOST

are detected in late stage, limiting treatment options3

Adding to the challenge, patients often face numerous barriers to screening, even for cancers that have existing screening options. This includes barriers at the socioeconomic, personal, and societal level that may prevent many people from following through with recommended screenings. Underserved populations experience even higher rates of cancer and mortality, widening the gap in health disparities.4,5

*Calculated using estimated new diagnoses and deaths from cancers that have standard-of-care screening: breast, cervical, colorectal, and lung (high risk) against all sites.

Calculation derived from American Cancer Society statistics on average 5-year relative survival rates for 19 leading cancers.

Impacting decisions across the cancer continuum. Because knowing is everything.

With nearly 3 decades of experience in cancer screening and testing, Exact Sciences has developed cancer tests that have given millions of people the clarity to take life-changing action earlier.

>12 million screenings for colon cancer at home

Cologuard®, the first and only FDA-approved multi-target stool DNA-based screening test,9 has made more than 12 million at-home colon cancer screenings possible.10

>1.5 MILLION BREAST CANCER PATIENTS TESTED TO HELP MAKE INFORMED TREATMENT DECISIONS

The Oncotype DX Breast Recurrence Score® test can be used to predict the benefit of chemotherapy in patients with early-stage HR+, HER2- breast cancer.

Building on the success of the Cologuard® and Oncotype DX® tests, we are continually developing innovative solutions for use before, during, and after a cancer diagnosis.

Exact Sciences home page

At Exact Sciences, we are committed to closing the gaps in cancer screening by developing an innovative blood test that screens for more cancers, enabling early detection for more people.

A fundamentally new approach to cancer screening3

When used alongside single-organ standard-of-care cancer screenings, such as breast and colorectal cancer screenings, multi-cancer early detection (MCED) tests may offer the potential to transform the way we screen for cancer.3,6,7

Multi-Cancer Early Detection Tests

Laying the groundwork in MCED

Exact Sciences has been leading the development of MCED testing in collaboration with researchers at premier institutions such as Johns Hopkins University and the Mayo Clinic.

to complete a prospective interventional study of an MCED test


to receive FDA breakthrough device designation for an MCED test

In 2016, scientists at Johns Hopkins built upon breakthrough discoveries they had made to create CancerSEEK, a forerunner to the Cancerguard™ test that is currently in development.7,11-13 A proof-of-concept study was published in 2018,12 and the test received an FDA designation as a Breakthrough Device, making it the first MCED test to receive this designation. As a continuation of this work, we have conducted various studies focused on improving the performance of this revolutionary test.

2016
Development of the MCED test, CancerSEEK, begins
2018
Published Cohen proof-of-concept study12
2018
FDA designation of the CancerSEEK as Breakthrough Device
2020
DETECT-A study: CancerSEEK doubled the number of screen-detected cancers7
2020
Douville et al. study: Demonstrated improved sensitivity of a multi-biomarker class MCED test13
2021
Katerov et al. study: Detection of multiple cancers14
2022
Allawi et al. study: Delivered high sensitivity across multiple cancer types15
2022
PRE-ASCEND: Multi-biomarker class test design improved early-stage sensitivity16
2023
Ongoing work for finalization of our MCED test in development

Today, we are working on developing the MCED test of the future—the Cancerguard™ test

The Cancerguard™ 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. American Cancer Society. Cancer facts and figures 2022. Accessed August 29, 2023. https://www.cancer.org/latest-news/facts- and-figures-2022.html
  2. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; doi:10.3322/caac.21820
  3. Ahlquist DA. Universal cancer screening: revolutionary, rational, and realizable. NPJ Precis Oncol. 2018;2:23.
  4. Sabatino SA, Thompson TD, White MC, et al. Cancer Screening Test Receipt - United States, 2018. MMWR Morb Mortal Wkly Rep. 2021;70(2):29-35.
  5. Muthukrishnan M, Arnold LD, James AS. Patients’ self-reported barriers to colon cancer screening in federally qualified health center settings. Prev Med Rep. 2019;15:100896.
  6. Beer TM. Examining developments in multicancer early detection: highlights of new clinical data from recent conferences. Am J Manag Care. 2021;27(19 Suppl):S347-S355.
  7. 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):eabb9601.
  8. Cancer Moonshot. The White House. Accessed August 29, 2023. https://www.whitehouse.gov/cancermoonshot
  9. Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
  10. Next generation Cologuard® test demonstrates 94 percent sensitivity for colorectal cancer at 91 percent specificity, raising the bar in non-invasive screening. News release. Exact Sciences; June 20, 2023. Accessed September 14, 2023. https://www.exactsciences.com/newsroom/press-releases/ next-generation-cologuard-test-demonstrates-94-percent-sensitivity
  11. Douville C, Nobles C, Hwang HJ, et al. Multi-cancer early detection through evaluation of aneuploidy, methylation, and protein biomarkers in plasma. Poster presented at: ESMO Congress; September 9-13, 2022; Paris, France. Abstract 73P.
  12. Cohen JD, Li L, Wang Y, et al. Detection and localization of surgically resectable cancers with a multi-analyte blood test. Science. 2018;359(6378):926-930.
  13. Douville C, Cohen JD, Ptak J, et al. Assessing aneuploidy with repetitive element sequencing. Proc Natl Acad Sci U S A. 2020;117(9):4858-4863.
  14. Katerov S, Vaccaro A, Hennek J, et al. Accurate multi-cancer detection using methylated DNA markers and proteins in plasma. Presented at: American Association for Cancer Research Annual Meeting 2021; April 10-15 and May 17-21, 2021; Philadelphia, PA. Abstract 111.
  15. Allawi HT, Katerov S, Vaccaro A, et al. Validation of a panel of methylated DNA and protein markers for multi-cancer detection in plasma. Presented at: American Association for Cancer Research Annual Meeting 2022; April 8-13, 2022; New Orleans, LA. Abstract 631.
  16. Gainullin V, Hagmann L, Arvai K, et al. Improved sensitivity of a multi-analyte early detection test based on mutation, methylation, aneuploidy, and protein biomarkers. Presented at AACR Special Conference: Precision, Prevention, Early Detection, and Interception of Cancer 2022; November 17-19; Austin, TX. Abstract P041.