Cancerguard™ / The Science
The Cancerguard™ Test
Our vision ahead
While the multi-cancer early detection (MCED) field is still in its beginning stages, it shows great promise as a fundamentally new approach to the screening and detection of cancer. These tests are designed to be used alongside standard-of-care screening.1-3 To unlock the full potential of MCED testing, Exact Sciences is taking a rigorous, comprehensive approach to developing the Cancerguard™ test.
Criteria that we believe are essential to an impactful MCED test:
Harness the additive sensitivity of multiple biomarker classes
Detect multiple cancers, including those with the biggest impact to public health
Provide high specificity to help minimize false positive results
Deliver high sensitivity to detect more early-stage cancers, when there is a greater chance for curative intervention
Utilize a streamlined and standardized imaging-based diagnostic resolution pathway that results in fewer procedures
DETECT-A RESULTS
The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the MCED test currently in development.
The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting. The DETECT-A 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.3
2020 DETECT-A Results3
Doubled the number of screen-detected cancers
Detected cancers without recommended screening
Rosemary’s story
Hear from a participant of the clinical trial for an early version of the MCED test we’re developing.
The latest data show the potential value of a multi-biomarker class design
The complementary nature of different biomarker classes demonstrated by DETECT-A inspired further study into multi-biomarker cancer detection. A recent study has demonstrated the potential value of a multi-biomarker class test design combining mutations, methylation, proteins, and aneuploidy in the early detection of multiple cancers.4
Case-Control Study Ongoing Work
In a retrospective case-control study evaluating the performance of a multi-biomarker class MCED test in 3,645 people, results demonstrated the potential of the MCED test to improve early-stage cancer detection when cancer is more treatable.4
Detected cancer
in all organ types tested, which represent ~75% of all cancer deaths5*
Achieved >62% overall sensitivity**
Stage I: 30.4%
Stage II 50.4%4
Maintained high specificity
to help minimize false positive results4
*Calculated using estimated new deaths from cancers in all sites against those used in analysis: breast, bladder, colon and rectum, esophageal, kidney, liver, lung, ovarian, pancreatic, prostate, stomach, uterine, non-Hodgkin lymphoma, multiple myeloma, and myelodysplastic syndrome.
** Sensitivity in case-control studies is an important measure during the development of a test but is not meant to represent the performance of the test in prospective studies or in routine use.
Continuing our rigorous approach to clinical development
The next steps in our commitment to improving and validating a novel MCED test include completion of ongoing studies to finalize the biomarker selection for the Cancerguard™ test in development while preparing to initiate a prospective, interventional, longitudinal pivotal trial.
Exact Sciences has joined forces with the broader cancer community, patient advocacy organizations, and forums—such as the MCED Consortium, BLOODPAC, and the American Cancer Society—to help to shape the future of cancer detection. Together we are working towards a shared goal to help reduce cancer’s burden on humanity.
We are growing thought leadership for the MCED field
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
- Ahlquist DA. Universal cancer screening: revolutionary, rational, and realizable. NPJ Precis Oncol. 2018;2:23.
- 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.
- 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.
- 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.
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; doi:10.3322/caac.21820