Exact Sciences to Present Late-Breaking Data from ASCEND-2 Study Validating Its Investigational Multi-Cancer Early Detection Test at AACR Annual Meeting 2024

First analysis from ASCEND-2 confirms high detection rates and specificity achieved with multi-biomarker approach in most aggressive cancers and those with no standard-of-care screening test¹

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, will present late-breaking data from the first analysis of the ASCEND-2 study demonstrating the compelling performance of its investigational multi-biomarker class, multi-cancer early detection (MCED) blood test. These results validate the sensitivity and specificity of the company’s multi-biomarker class approach across a broad range of cancer types, including the most aggressive cancers and cancers with no current standard of care for screening. ASCEND-2 is a large, multi-center, prospective, case-control study of over 11,000 clinically characterized participants from a racially, ethnically, and geographically diverse cohort representative of the U.S. population. These data will be presented at the American Association for Cancer Research® (AACR) Annual Meeting 2024, April 5-10 in San Diego, California.¹

“Cancer is the second-leading cause of death in the U.S., and while early detection is associated with longer survival, two-thirds of deaths are caused by cancers that lack standard screening tests. MCED tests have the potential to revolutionize cancer screening by enabling us to spot more cancers and intervene earlier,” said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences.^2-4 “This analysis from ASCEND-2 confirms that our multi-biomarker class approach to MCED test design may deliver benefits beyond what is currently achievable. The sensitivity and specificity achieved in the detection of the most aggressive cancers and those cancers with no current standard of care provide the confidence to move forward to a real-world evidence study.”

Exact Sciences will also present new outcomes data from DETECT-A, the first large prospective study of an earlier multi-biomarker class MCED test that enrolled more than 10,000 participants with more than four years of follow-up.⁵

The abstracts featured at AACR 2024 are as follows:

Title: Performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively collected cohort

Presenter: Diehl, F

Session: Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session LBPO.CL01)

Poster number: LB100/11

Location: Section 51

Key findings: First analysis of the refined multi-biomarker class MCED test achieved an overall sensitivity of 50.9% with 98.5% specificity and 56.8% sensitivity when breast and prostate cancer were excluded from the analysis. Sensitivity was 54.8% for cancers without standard-of-care screening for average-risk populations and 63.7% in the most aggressive cancers with the shortest 5-year survival rate (pancreas, esophagus, liver, lung and bronchus, stomach, and ovary).

Title: Case report: DETECT-A participants with pre-malignant conditions

Presenter: Rego, SP

Session: Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session PO.CL01.16)

Poster number: 2449/14

Location: Section 41

Key findings: Results showed that in the rare instance when MCED testing detected pre-cancerous conditions in the DETECT-A study, surgical interventions prevented cancer development, and all patients were cancer-free at follow-up.

About the ASCEND-2 study

The ASCEND-2 (Ascertaining Serial Cancer patients to Enable New Diagnostic 2) study is a large, multi-center, prospective, case-control study of clinically characterized participants. Key goals of the study are to develop the algorithm and identify the biomarkers to inform the final design of the Cancerguard™ test, Exact Sciences’ investigational, multi-biomarker class blood-based MCED test. ASCEND-2 has enrolled over 11,000 participants across 151 sites within the U.S. and Europe. The study population includes male and female subjects 50 years and over with known cancer, suspicion of cancer, and controls without cancer. ASCEND-2 selected cancer types in an incidence-targeted manner, including rare and common cancers and evenly distributed stages. By enrolling racially, ethnically, and geographically diverse participants, the study enables MCED test development with a widely representative cohort.

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. The Cancerguard test is currently under development. 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 healthcare 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.

Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences Corporation. Oncotype is a trademark of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation.

Forward-looking statements

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; the performance characteristics and healthcare benefits of the Cancerguard test; and the timing and anticipated results of FDA or any other national regulatory authority submission. 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. Gainhullin V., et. al. Abstract #LB100/11, AACR 2024.
2. American Cancer Society. Cancer facts and figures 2024. Accessed April 3, 2024. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf
3. Hawkes, N. Cancer survival data emphasise importance of early diagnosis. BMJ. 2019; doi:10.1136/bmj.l408
4. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; doi:10.3322/caac.21820
5. Choudhry, O., et. al. Abstract #2449/14, AACR 2024.

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