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 in the DETECT-A study inspired further studies on multi-biomarker class cancer detection. Late breaking data presented at the 2024 American Association for Cancer Research (AACR) conference details the outcomes of the first analysis from the ASCEND 2 study, demonstrating that a multi-biomarker class test combining methylation and protein biomarkers delivers sensitivity and specificity needed to detect numerous cancer types even at earlier stages and confirms the value of a multi-biomarker class approach.4
Prospectively Collected Case-Control Study
The first analysis from the ASCEND 2 study, a multi-center, prospectively collected case-control study of clinically characterized patients evaluated the performance of a multi-biomarker class MCED test in 6,354 patients. Results demonstrated combining an enhanced classifier design with two high-performing biomarker classes selected for their proven ability to identify cancer earlier delivers the sensitivity and specificity needed to make a real impact on patient care.4
Detected cancer
in all organ types tested, which represent ~85% of incident cancers4,5,*,**
Achieved >56% overall sensitivity**,^
Maintained high specificity
to help minimize false positive results4
* U.S. data. Calculated using estimated incidence from cancers in all sites against the 21 used in the analysis
** 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.
^ Excludes breast and prostate
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, Hwang, HJ, et al. Performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively-collected cohort. Presented at American Association for Cancer Research Annual Meeting 2024; April 5-10, 2024; San Diego, CA. Abstract LB100.
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; doi:10.3322/caac.21820