• Data to be presented expands the body of evidence around the predictive and prognostic value of the Oncotype DX^® test in all racial and ethnic groups
• New data showcase Exact Sciences’ commitment to innovation and strategies that expand access to effective cancer screening and diagnostic tools for patients

MADISON, Wis. / May 24, 2024 / Business Wire / Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, will present 10 abstracts highlighting the breadth and depth of the company’s screening and diagnostic portfolio at the American Society of Clinical Oncology^® (ASCO^®) Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, Ill. Presentations will include new data confirming both the predictive and prognostic value of the Oncotype DX Breast Recurrence Score^® test in racially and ethnically diverse patients. Exact Sciences will also present data on its approach to multi-cancer early detection (MCED) across multiple tumor types, plus additional real-world evidence showing optimized screening adherence strategies for the Cologuard^® test as well as high adherence rates for repeat screenings.

“Exact Sciences’ growing evidence shows that earlier and more personalized treatment interventions lead to greater success for people living with cancer. Therefore, effective cancer screening and diagnostic tools are critical to improving patient outcomes,” said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. “These data presented at ASCO support our goal to set new screening and diagnostic standards through rigorous innovation and real-world data collection across cancer care. We are committed to continuing to develop high-quality tests that meet the needs of all patients, regardless of race, age, or ethnicity.”

Precision Oncology

New data from two studies evaluating Recurrence Score^® results showed that the Oncotype DX Breast Recurrence Score test predicted breast cancer survival across different racial and ethnic groups. The first study confirmed that the test is prognostic for breast cancer-specific mortality and predictive of chemotherapy benefit across racial and ethnic groups in lymph node-negative patients, following propensity score-adjusted analyses. This real-world study of more than 171,000 patients with nonmetastatic, hormone receptor-positive, HER2-negative breast cancer with a Recurrence Score result from the SEER database also showed that the Recurrence Score result was predictive of chemotherapy benefit across all node-positive patients. In the study, non-Hispanic Black patients were shown to have a higher Recurrence Score result and chemotherapy usage compared to other groups. Exploratory analyses of the RxPONDER trial showed that while the test remained prognostic across racial and ethnic groups, non-Hispanic Black patients had higher proliferation axis scores, suggesting that differences in tumor biology may help explain differences in breast cancer outcomes.

Screening

New data suggests benefits of multi-cancer early detection (MCED) in identifying cancers earlier, with patients having a shorter time to diagnosis and fewer late-stage (Stage IV) diagnoses. In a modeling analysis, when MCED was evaluated across 12 different cancer types, it resulted in fewer Stage IV diagnoses relative to diagnosis through usual care, with 38% of Stage IV reductions attributed to cancers without recommended screening guidelines.

Exact Sciences will also share real-world evidence showing high adherence and three-year repeat rate of the Cologuard test. It will also share data demonstrating success with using different digital outreach approaches to help improve screening adherence, leading to high screening completion rates for the Cologuard test across different patient populations.

Data presentations across Exact Sciences' Precision Oncology and Screening portfolio at ASCO 2024:

Precision Oncology

Abstract 515: Recurrence Score^® Gene Axes Scores by Race and Ethnicity in the RxPONDER Trial
Presenter: Y. Abdou, MD
Session: Rapid Oral Abstract Session
Date/time: Friday, May 31, 3:39 PM – 3:45 PM CDT
Key findings: This study analyzed Recurrence Score gene axis scores and their associations with outcomes to understand the differences in underlying tumor biology among different racial and ethnic groups. Recurrence Score gene axis scores differed by race/ethnicity, with Non-Hispanic Black patients exhibiting higher proliferation axis scores than other groups. This could partially explain the poorer outcomes observed in this population in the RxPONDER trial. These findings highlight the importance of tumor biology and support further investigation into the intricate factors contributing to disparities in outcomes to address them effectively.

Abstract 533/Poster Bd 125: Updated SEER database study of 21-gene assay to assess breast cancer-specific mortality and benefit of chemotherapy by race and ethnicity
Presenter: E. Diego, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Real-world evidence from the SEER registries in over 145,000 patients with breast cancer confirms that the Oncotype DX Breast Recurrence Score test is prognostic of breast cancer-specific survival across all racial and ethnic groups and predictive of chemotherapy benefit across most groups. This study was performed to further understand the racial and ethnic disparities identified in the TAILORx and RxPONDER phase 3 trials, which used the Oncotype DX test to identify patients with node-negative or node-positive breast cancer who may or may not benefit from chemotherapy. This latest SEER analysis provides further confidence in the prognostic value of the Oncotype DX test regardless of race or ethnicity.

Abstract 508: Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-) node-positive breast cancer
Presenter: L. Pusztai, MD, PhD, FASCO
Session: Oral Abstract Session
Date/time: Monday, June 3, 5:24 PM – 5:35 PM CDT
Location: Hall B1
Key findings: The RSClin^® N+ tool model delivers improved estimates of prognostic risk and absolute chemoendocrine therapy benefit over clinical or genomic data alone for patients with node-positive, HR+/HER2- breast cancer and could be used in patient counseling. Building upon the success of the RSClin tool, the N+ version of the RSClin tool integrates the Recurrence Score result with clinicopathologic factors, stratified by menopausal status, to further enhance its prognostic and predictive value for patients with node-positive disease.

Abstract 576/Poster Bd 168: Evaluating Ki67 and Oncotype DX Recurrence Score during neoadjuvant treatment with letrozole/abemaciclib or chemotherapy in highly proliferative HR+/HER2- breast cancer patients participating in the GEICAM CARABELA trial.
Presenter: A. Guerrero, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Highly proliferative breast cancer tumors (Ki67 ≥40%) or those with high Recurrence Score results (>25) showed lower residual cancer burden after neoadjuvant chemotherapy treatment versus neoadjuvant letrozole plus abemaciclib. These data confirm the predictive value of Ki67 and Recurrence Score risk assessments and suggest that relying solely on letrozole/abemaciclib as a systemic treatment for these tumors may be insufficient. This is an exploratory analysis from the CARABELA phase 2 trial, which is comparing the efficacy of neoadjuvant chemotherapy vs. neoadjuvant letrozole/abemaciclib treatment in patients with HR+/HER2- breast cancer who are at high/intermediate risk (stage II-III, Ki67≥20%).

Abstract 565: Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the Recurrence Score® in node-positive breast cancer: independent validation in the PACS-01 trial
Presenter: F.M. Penault-Llorca, MD, PhD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Combining the Oncotype DX Breast Recurrence Score test with the Sensitivity to Endocrine Therapy (SET2,3) index, a biomarker-based assessment designed to assess a tumor's response to hormonal therapy, successfully enhanced the prognostic value for patients with node-positive breast cancer. These are data from an independent, blinded validation analysis of the PACS-01 trial, which evaluated sequential adjuvant epirubicin-based and docetaxel chemotherapy for patients with node-positive breast cancer.

Abstract 10584/Poster Bd 111: Clinical and economic benefit of genomic testing strategies to guide the treatment of patients with HR+/HER2- breast cancer in the US
Presenter: B. Heald, MS
Session: Poster Session
Date/time: Monday, June 3, 1:30 PM CDT
Location: Hall A
Key findings: Using a testing strategy that combines both the Oncotype DX Breast Recurrence Score test and germline genetic testing (GGT), which identifies potentially pathogenic cancer variants, can help optimize treatment decisions in early HR+/HER2- breast cancer and improve patient outcomes at reduced costs, according to this health economic modeling study.

Screening

Abstract 11135/Poster Bd 330: Time-to-diagnosis and peri-diagnostic healthcare utilization between screen- and non-screen detected cancers: Evidence from SEER-Medicare
Presenter: X. Cao, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: Effective cancer screening programs successfully shortened the time to diagnosis and reduced the frequency of stage 4 diagnoses for patients with breast or colorectal cancer detected through screening. This retrospective SEER registry analysis reinforces that effective cancer screening technologies have the potential to improve patient outcomes by enabling earlier detection when treatment options are typically most successful.

Abstract 11076/ Poster Bd 271: Effect of multi-cancer early detection testing on late-stage cancers: A modeling study
Presenter: J. Chhatwal, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: In a 50-year modeling simulation, MCED testing resulted in 1,323 fewer Stage IV (24%) cancer diagnoses overall compared to usual care. Thirty-eight percent of these Stage IV reductions were attributable to screening for cancers without recommended guidelines, underscoring the potential of novel MCED strategies to help catch cancers earlier and initiate treatment interventions sooner.

Abstract e15632: Real-world multi-target stool DNA adherence in an underserved and vulnerable prison patient population.
Presenter: J. Kasselman
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: Among incarcerated persons, mt-sDNA yielded high adherence rates (95.3%) and short completion times (average of 20 days) in this difficult-to-reach population. These data further demonstrate the importance of efforts to uncover patient, provider, and system-level benefits that may be obtained through broader adoption of this highly accessible screening approach in this challenging healthcare setting.

Abstract e15633: Real-world multi-target stool DNA longitudinal adherence for colorectal cancer re-screening in a large, national population
Presenter: M. Greene
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: In a real-world longitudinal analysis of 481,748 patients, adherence to repeat colorectal cancer (CRC) screening with the Cologuard test remained high (83.6%), and patients who underwent repeat screening once were more likely to continue with a third lifetime Cologuard screening. These data suggest high perceived patient confidence in Cologuard, further reinforcing its potential to help close the CRC screening gap for average-risk individuals.

About Exact Sciences’ Precision Oncology portfolio

Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score^® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX^® test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra^® test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. The Riskguard^™ hereditary cancer test provides an individualized patient report that includes gene-specific and familial risks using a simple blood or saliva sample for 10 common cancers: colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney, and endocrine. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine. To learn more, visit precisiononcology.exactsciences.com.

About Cologuard

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in The New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

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. NOTE: Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. Cologuard is not available outside of the U.S. Exact Sciences’ multi-cancer early detection test is still in development.

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 expectations for development and commercialization of new or improved products and services and their impacts on patients, and our strategies, positioning, resources, capabilities and expectations for future events or performance. 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.