Exact Sciences Advances Early Cancer Detection and Precision Oncology Programs with Data Presentations at ESMO 2023 Annual Congress

By Exact Sciences / October 21, 2023

MADISON, Wis., October 20, 2023 – Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present new data supporting the company’s research in early cancer detection, genomic testing, and treatment guidance at the 2023 European Society for Medical Oncology (ESMO) Congress, October 20-24, in Madrid, Spain.

Exact Sciences will feature studies from across its multi-cancer early detection (MCED) and precision oncology portfolios, highlighting:

Two trials evaluating the company’s blood-based, MCED program^1,2
OncoExTra^™ data showing the frequency of the detection of actionable fusions, signals of some cancers, in nearly 8,000 people with solid tumors, helping inform treatment decisions by using next-generation sequencing (NGS) to assess a tumor’s RNA and DNA³

“At Exact Sciences, we are driving paradigm shifts in the early detection and treatment of cancer,” said Jorge Garces, Ph.D., chief science officer, Exact Sciences. “With continued advances in understanding tumor biology and the precise identification of actionable biomarkers, our screening and diagnostic tools are improving the lives of people living with or at risk for cancer today – and are poised to transform the cancer landscape in the future.”

Cancerguard^™

Exact Sciences is taking a robust and rigorous approach to developing an MCED test, and today unveiled its brand name, Cancerguard. Building upon decades of research, Exact Sciences is designing the Cancerguard test to harness the additive sensitivity of multiple biomarker classes to detect more early-stage cancers. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, resulting 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 impact on human health. To learn more, visit http://www.exactsciences.com/cancerguard

The company will host a symposium at the congress titled “Shifting the Paradigm of Cancer Detection: Multi Cancer Early Detection,” featuring experts from leading oncology research institutions and Exact Sciences. The session will highlight research ushering in the era of MCED tests, including results from multiple studies that support a vision for the future where MCED testing, added to current recommended cancer screenings, may help identify more cancers in earlier stages and have an impact on public health.

Key Data Presentations at
ESMO 2023^1-6

LBA24: Multiparametric prognostic score in early HR+/HER2- breast cancer: Impact of Recurrence Score (RS), clinical-pathological factors, gene mutations and histology

Data embargoed until 00:05 CEST / 6:05 AM EDT on Thursday, 19 October 2023
Authors: Gluz, O. et al.
Date/Time: October 23, 2023, 11:05 AM CEST
Location: Bilbao Auditorium (Mini-Oral session, Breast Cancer Early Stage)

Key Takeaway: Exploratory analysis of data from Phase III ADAPT trial to determine if expanding use of clinical-pathological factors, including adaptive factors (e.g., Ki67 response), provides additional clinically useful prognostic information when added to the Recurrence Score in multivariable models.⁴

Abstract #183P: Frequency of actionable fusions in 7,735 patients with solid tumors

Data embargoed until 00:05 CEST / 6:05 PM EDT on Monday, October 16
Authors: McDonnell, K. et al.
Date/Time: October 21, 2023, 7:30 AM CEST
Location: Hall 8

Key Takeaway: Comprehensive genomic profiling approaches that include RNA sequencing can improve fusion detection compared to exome or targeted DNA sequencing alone. This study demonstrates the potential of the OncoExtra^™ test to identify fusions that are relevant for determining therapy, disease prognosis or clinical trial eligibility.³

Abstract #317P: Awareness of genomic testing among patients with breast cancer in Europe

Data embargoed until 00:05 CEST / 6:05 PM EDT on Monday, October 16
Authors: Cardone, A. et al.
Date/Time: October 21, 2023, 7:30 AM CEST
Location: Hall 8

Key Takeaway: This study demonstrates that awareness of and access to genomic testing for breast cancer in Europe is sub-optimal. Genomic testing, involving expression profiling of tumor tissue removed from patients with breast cancer, is a powerful tool to help choose the most appropriate treatment for individual patients. Researchers surveyed women with HR+/ HER2 - breast cancer, eligible for genomic testing at the time of diagnosis, in five Western Europe countries about their awareness of genomic testing for treatment decision making.⁵

Abstract #189P: Design and enrollment for a classifier development study for a blood-based multi-cancer early detection (MCED) test

Data embargoed until 09:00 CEST / 3:00 PM EDT on Saturday, October 21
Authors: Douville, C. et al.
Date/Time: October 21, 2023, 09:00 AM CEST
Location: Hall 8

Key Takeaway: The Ascertaining Serial Cancer patients to Enable New Diagnostic 2 (ASCEND 2) study selected cancer types in an incidence-targeted manner, including rare and common cancers and evenly distributed stages. The ASCEND-2 study represents a racially, ethnically, and geographically diverse cohort for MCED test development.¹

Abstract #202P: Participant perceptions and mammography adherence from DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test

Data embargoed until 00:05 CEST / 6:05 PM EDT on Monday, October 16
Authors: Papadopoulos, N. et al.
Date/Time: October 21, 2023, from 09:00-17:00 CEST
Location: Hall 8

Key Takeaway: These data suggest that MCED testing did not significantly increase anxiety and depression or negatively impact mammography adherence for respondents with available data.²

Symposium at ESMO 2023:

Title: Shifting the Paradigm in Cancer Detection

Co-chairs:
Elizabeth O’Donnell, MD, Dana-Farber Institute & Harvard Medical School
Tomasz Beer, MD, FACP, Co-chair Chief Medical Officer and VP, Multi-cancer Early Detection, Exact Sciences
Faculty:
Nickolas Papadopoulos, PhD, Ludwig Center & The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Catherine Marinac, PhD, Dana Farber Institute & Harvard Medical School
Frank Diehl, PhD SVP Research and Development, Exact Sciences
Date/Time: Monday, October 23, 13:00 CEST
Location: Burgos Auditorium Hall 3, IFEMA MADRID, Madrid, Spain

Summary: Multi-cancer early detection (MCED) testing may help shift the paradigm in cancer screening, enabling detection of more cancers in earlier stages when they are more treatable. Results from multiple studies have demonstrated the potential value of MCED testing, and recent studies combining multiple biomarker classes in MCED test design have demonstrated the ability to enhance test performance for early-stage cancer detection. These results support a vision for the future where MCED testing is a part of routine primary care screening.⁶

This symposium is intended for healthcare providers and may discuss agents and products in development that have not been cleared or approved in your country or by any other national regulatory authority. The European Society for Medical Oncology (ESMO) does not endorse any company, or their products/services.

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.

NOTE: Exact Sciences^™ is a registered trademark of Exact Sciences Corporation. Oncotype^™ and OncoExTra^™ are registered trademarks of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.

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 next-generation Cologuard^™ test; the performance characteristics of next-generation Cologuard^™ in a commercial setting; and the timing and anticipated results of additional analysis of the BLUE-C data and FDA 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.

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