Exact Sciences Unveils Data Showing Promise of Multi-Cancer Early Detection at AACR Special Conference on Liquid Biopsy

Rhea-AI Summary

Exact Sciences (NASDAQ: EXAS) presented three abstracts showcasing advancements in multi-cancer early detection (MCED) testing at the AACR Special Conference. A new study demonstrated that their multi-biomarker class approach improved cancer detection sensitivity, showing a 28% increase for stage I cancers and 12.5% for early-stage cancers at 98.5% specificity. New modeling data suggests that adding MCED testing to standard screening could reduce stage IV cancer incidence by 42% and cancer mortality by 17% over 10 years. Analysis from the DETECT-A study indicated MCED testing complements existing lung cancer screening without affecting adherence to standard care.

Positive

• Multi-biomarker class approach showed 28% increased sensitivity for stage I cancer detection
• Modeling data projects 42% reduction in stage IV cancer incidence
• Estimated 17% reduction in cancer mortality over 10 years with MCED testing
• MCED testing demonstrated compatibility with existing screening protocols without reducing adherence

Negative

• None.

Insights

Medical Research Analyst

The new MCED test data from Exact Sciences represents a significant breakthrough in early cancer detection technology. The multi-biomarker approach shows impressive improvements, with a 28% increase in Stage I cancer detection sensitivity and 12.5% increase for early-stage cancers overall (excluding breast and prostate cancers). Most notably, the modeling data suggests a potential 42% reduction in stage IV cancer incidence and 17% reduction in cancer mortality over 10 years when combined with standard screening.

The DNA mutation reflex approach, combined with methylation and protein biomarkers, demonstrates superior detection capabilities compared to previous methods. This technological advancement could substantially impact cancer diagnosis and treatment outcomes, particularly given that only 14% of U.S. cancers are currently detected through screening.

Market Research Analyst

This development positions Exact Sciences favorably in the competitive cancer diagnostics market. The Cancerguard™ test's multi-biomarker approach could represent a significant revenue opportunity, especially considering the large untapped market for early cancer detection. The DETECT-A study results showing no negative impact on standard screening adherence is particularly important for market adoption and potential insurance coverage.

The 98.5% specificity rate is important for widespread clinical adoption, as it indicates a low false-positive rate. This could lead to stronger reimbursement potential and broader acceptance among healthcare providers, potentially driving substantial market growth for Exact Sciences in the multi-cancer screening segment.

New evidence shows multi-biomarker class approach improved cancer detection, including in earlier stages when treatment may be more effective

Modeling data estimate adding MCED testing to standard-of-care screening could reduce cancer mortality by 17%

New analysis from DETECT-A study supports MCED testing as a complement to current guideline-recommended screening

MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, will present three abstracts highlighting significant advancements in the development of a multi-cancer early detection (MCED) test. The results of a study evaluating a new multi-biomarker class approach showed improved sensitivity for early-stage and overall cancer detection. In addition, new modeling data estimate that adding MCED testing to recommended screening may reduce the incidence of stage IV cancer and, subsequently, cancer mortality over 10 years. Another new analysis from the DETECT-A study suggests that adding MCED testing complements guideline-recommended lung cancer screening without affecting adherence to current standard of care. These findings will be presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Liquid Biopsy from November 13-16, 2024, in San Diego, Calif.

“Cancer is on pace to be the leading cause of death in the U.S. by 2030¹. Currently, only an estimated 14% of all cancers in the U.S. are diagnosed through screening,² revealing a glaring gap in patient care,” said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. “We believe MCED testing is our single biggest opportunity to combat these stark statistics, and the Exact Sciences team is committed to taking a rigorous, comprehensive approach to multi-cancer screening. The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice.”

A new study demonstrates the ability of a multi-biomarker class MCED test to improve early-stage sensitivity by incorporating a DNA mutation reflex approach to methylation and protein (MP) test results. When excluding breast and prostate cancer and at a 98.5% specificity, sensitivity increased by 28% for stage I cancers and 12.5% for early-stage cancers (stages I and II) in a case-control study, underscoring the potential of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) test to improve the detection of cancer in earlier stages.

Cancer stage	MP-r sensitivity	MP sensitivity	% improvement
Stage I	22.1%	17.2%	28.0%
Stage II	54.7%	51.9%	5.5%
Stage I/II	35.9%	31.9%	12.5%
Overall	62.3%	59.3%	5.0%

This new research will help inform the final design of Exact Sciences’ Cancerguard™ test, which is currently in development and intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages.

The abstracts featured at the AACR Special Conference: Liquid Biopsy 2024 are as follows:

Title: Performance of multi-biomarker class reflex testing in a prospectively-collected cohort
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A056
Key findings: A new analysis from a case-control study demonstrated the ability of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) MCED test approach to increase sensitivity for early-stage detection. When excluding breast and prostate cancer, stage I sensitivity increased by 28%, and stage I/II increased by 12.5%.

Title: The potential of multi-cancer early detection screening for reducing cancer mortality
Oral presentation: Friday, November 15, 9:35 a.m. PT (Plenary Session 4: Early Detection of Primary Cancer and Relapse)
Presenter: Tyson, C
Poster number: PR006, A073
Key findings: New modeling points to the potential to reduce the burden of cancer by demonstrating an estimated 42% reduction in stage IV cancer incidence and a 17% estimated 10-year reduction in cancer mortality with the addition of MCED testing to usual care.

Title: Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A064
Key findings: Analysis from the prospective, interventional DETECT-A study showed lung cancer screening adherence was not reduced in participants who received an MCED test compared to controls.

About the DETECT-A study

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. The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the Cancerguard test, the MCED test currently in development at Exact Sciences.

About the Cancerguard™ test

The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research, Exact Sciences intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, which may result in fewer follow-up procedures. The test is being developed to provide high specificity to help minimize false positives while detecting multiple cancers, including those with the biggest toll on human health. These features describe current development goals. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority. To learn more, visit http://www.exactsciences.com/cancerguard.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

Forward-Looking Statement

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the development and commercialization of the Cancerguard test, and the performance characteristics and healthcare benefits of the Cancerguard test. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

References:

1. CDC Archive. Future Health of our Nation Infographic. Accessed July 12, 2024.
2. NORC at the University of Chicago. New Research Highlights Just One In Seven Diagnosed Cancers Found By A Recommended Screening Test. Accessed October 31, 2024. Limitations: Based on modeling data derived from numerous sources including self-reported surveys. Includes assumptions on detectability of certain cancer types. Does not include all cancer types or screening methods. 

 

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Exact Sciences

Media Contact: Allison Barry, abarry@exactsciences.com, 980.297.1957

Investor Contact: Erik Holznecht, investorrelations@exactsciences.com, 608.800.6605

Source: Exact Sciences Corp.

FAQ

What improvement in early-stage cancer detection did Exact Sciences (EXAS) report for their MCED test?

Exact Sciences reported a 28% increase in sensitivity for stage I cancers and 12.5% increase for early-stage cancers (stages I and II) at 98.5% specificity.

What are the projected mortality reduction rates for Exact Sciences' (EXAS) MCED testing?

According to modeling data, adding MCED testing to standard care could reduce cancer mortality by 17% over 10 years.

How does Exact Sciences' (EXAS) MCED testing affect existing lung cancer screening protocols?

According to the DETECT-A study, MCED testing complements existing lung cancer screening without negatively affecting adherence to standard-of-care protocols.