Exact Sciences Strengthens Evidence Supporting Cologuard® and Oncotype DX® Tests and Deep Oncology Pipeline with Multiple Data Presentations at ASCO 2021

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May 19, 2021, 17:15 ET

MADISON, Wis., May 19, 2021 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, today announced new data on its cancer tests and treatment guidance tools will be showcased in seven presentations and one e-abstract at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8. Data presented will reinforce the value of the Oncotype DX^®tests in informing personalized treatment decisions and highlight industry research from Thrive, an Exact Sciences company, outlining the need to incorporate a blood-based, multi-cancer screening test into routine clinical care.

"We're thrilled to participate in ASCO, alongside our collaborators at leading academic and medical institutions," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is changing the way we detect and treat cancer. The data being presented demonstrate our commitment to providing earlier answers and life-changing treatment guidance to patients and physicians, while strengthening our current tests and accelerating the introduction of new, innovative diagnostics."

Studies supporting Exact Sciences screening and earlier detection efforts consist of a Cologuard^®(mt-sDNA) modeling study in collaboration with Mayo Clinic to assess the impact of sessile serrated polyps on predicted colorectal cancer outcomes with Cologuard or FIT screening¹, and clinical research from Thrive that emphasizes the need for integrating a multi-cancer screening test into the standard of care².

Data being presented on the Oncotype DX^®test portfolio include a new analysis, based on first results from the independent RxPONDER study, that reinforce the cost-effectiveness of the Oncotype DX Breast Recurrence Score^® test in node-positive early-stage breast cancer³; an oral presentation from the West German Study Group (WSG) on the prospective phase III ADAPT study which used the Oncotype DX test to stratify patients with early-stage breast cancer⁴; and results from a patient-specific meta-analysis of three validation studies of the Oncotype DX Colon Recurrence Score test⁵.

Also being presented are findings from City of Hope's Center for Precision Medicine that emphasize a comprehensive sequencing approach to help guide cancer treatment and assess risk for cancer and non-cancer diseases, using Exact Sciences' GEM ExTra^® panel⁶, and early study results from PFS Genomics Inc., a development stage company founded by radiation oncologists, recently acquired by Exact Sciences. PFS Genomics has identified a gene expression signature, named Profile for the Omission of Local Adjuvant. Radiation (POLAR), to predict whether women with early-stage invasive breast cancer, treated with breast conserving surgery, are likely to benefit from radiotherapy⁷.

Following are the seven abstracts that have been accepted at the 2021 ASCO Annual Meeting. The on-demand materials, including posters, will be available in the ASCO Meeting Library, starting at 9:00AM EDT on June 4, 2021.

Impact of the Sessile Serrated Polyp Pathway on Predicted Colorectal Cancer Outcomes in the CRC-AIM Model
Authors: Kisiel, J., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10545

Cancer screening utilization in patients diagnosed with cancer types with and without recommended screening modalities
Authors: Cohain, A., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10557

Utilizing commercial health insurance claims data to identify the impact of cancer screening and estimate the added benefit of a multi-cancer liquid biopsy ordered during routine physical exams
Authors: Cohain, A., Hathaway, C., et al.
Session: Publication Only: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: e22516

Cost-effectiveness of Oncotype DX Breast Recurrence Score test in postmenopausal women with node-positive early breast cancer based on the RxPONDER trial
Authors: Berdunov, V., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 534

Prognostic impact of Recurrence Score, endocrine response and clinical-pathological factors in high-risk luminal breast cancer: Results from the WSG-ADAPT HR+/HER2- chemotherapy trial
Authors: Gluz, O., et. al
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 504; Oral presentation on June 6, 2021 at 8 AM EDT.

Discovery and validation of a genomic signature to identify women with early-stage invasive breast cancer who may safely omit adjuvant radiotherapy after breast-conserving surgery
Authors: Sjöström, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 512

Patient-specific meta-analysis of 3 validation studies of the 12-gene Colon Cancer Recurrence Score Assay for recurrence risk assessment after surgery with or without 5FU and oxaliplatin.
Authors: Yothers, G., et al.
Session: Gastrointestinal Cancer – Colorectal and Anal
Abstract Number: 3599

Prospective genomic testing of unselected cancer patients yields insights about cancer susceptibility and non-cancer disease with therapeutic implications
Authors: Gray, S., et al
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10603

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About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter answers to give people the clarity to take life-changing action, earlier. Building on the success of Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its product pipeline to support patients throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score, Oncotype MAP Pan-Cancer Tissue, and Oncotype DX AR-V7 Nucleus Detect are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation. GEM ExTra is a registered trademark of Ashion Analytics, LLC, an Exact Sciences Company. 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. You should not place undue reliance on forward-looking statements. There can be no assurance that we will be able to (i) realize the anticipated benefit from the acquisition of PFS Genomics or (ii) successfully develop or commercialize any products or services utilizing PFS Genomics' technology. 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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¹ Kisiel, J., et al. Abstract #10545, ASCO 2021.

² Cohain, A., et al. Abstracts #10557 & e22516, ASCO 2021.

³ Berdunov V. et al. Abstract #534, ASCO 2021.

⁴ Gluz, O., et. Al. Abstract #504, ASCO 2021.

⁵ Yothers, G., et al. Abstract #3599, ASCO 2021.

⁶ Gray, S., et al. Abstract #10603, ASCO 2021.

⁷ Sjöström, M., et al. Abstract #512, ASCO 2021.

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