CEO.CA Chairman's Briefing

MADISON, Wis., May 30, 2022 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leader in advanced cancer diagnostics, today announced new data supporting its cancer tests and treatment guidance tools will be showcased in nine poster presentations and five e-abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7 in Chicago, Illinois.

"As the leading cause of death worldwide,¹ cancer creates tremendous human suffering and staggering health care costs. Tests to help catch the disease earlier and guide more effective treatment are necessary to improve outcomes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Together with our collaborators from leading medical institutions, Exact Sciences is proud to present extensive data at this year's ASCO Annual Meeting. These presentations highlight the breadth of our pipeline and portfolio of tests as part of our relentless efforts to advance the field of cancer diagnostics."

Studies supporting Exact Sciences' screening and earlier detection efforts include a comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests. The modeled outcomes suggest blood-based tests result in detecting fewer colorectal cancer cases compared to stool-based tests due to differences in colorectal cancer sensitivity and specificity and lower advanced adenoma detection rates.² A cost-effectiveness analysis that assumed adherence to stool-based screening and/or follow-up colonoscopy increased when coinsurance was waived showed improvement in outcomes including life years gained and CRC incidence and mortality reductions.³ Another study indicated a shorter time to diagnosis for screenable versus symptom-driven cancers, supporting an expanded use of multi-cancer testing.⁴

Also being presented are findings from Mayo Clinic as part of the academic center's ongoing collaboration with Exact Sciences to advance the use of methylated DNA markers in detecting a range of cancer types, including cutaneous melanoma, prostate cancer, and lymphoma.⁵

Data highlighting Exact Sciences' precision oncology portfolio of tests will also be presented. The analyses support use of Oncomap™ and Oncomap™ ExTra, comprehensive genomic profiling tests formerly known as the Oncotype Map™ Pan-Cancer Tissue and GEM ExTra^® tests, respectively, to inform targeted therapy selection and clinical trial options for patients with advanced solid tumors.⁶ Also being presented is an overview of the ongoing CORRECT-MRD II study, designed to generate clinical validation data for the company's minimal residual disease assay in Stage II and III colorectal cancer patients.⁷

Following are details for the fourteen abstracts that have been accepted at the 2022 ASCO Annual Meeting. All abstracts are now available in the ASCO Meeting Library.

Saturday, June 4

NSABP C-14: CORRECT-MRD II – Second colorectal cancer clinical validation study to predict recurrence using a circulating tumor DNA assay to detect minimal residual disease
Authors: Salem, M., et al.
Session: Gastrointestinal Cancer ‒ Colorectal and Anal
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: TPS3632

Methylated DNA markers in early detection of lymphoma: Discovery, validation, and clinical pilot
Authors: Witzig, T., et al.
Session: Hematologic Malignancies ‒ Lymphoma and Chronic Lymphocytic Leukemia
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 7562

Sunday, June 5

Comprehensive genomic profiling to identify gene alterations in DNA repair pathway across solid tumors  
Authors: McDonnell, K., et al.
Session: Developmental Therapeutics ‒ Molecularly Targeted Agents and Tumor Biology
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 3124

Monday, June 6

Comprehensive whole-exome and transcriptome profiling to identify actionable alterations associated with response to PARP inhibitors in breast cancer
Authors: Dombrowski, S., et al.
Session: Breast Cancer ‒ Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 1096

BRAF mutation classes and co-occurring mutations in NSCLC
Authors: Niu, J., et al.
Session: Lung Cancer ‒ Non-Small Cell Metastatic
Poster Discussion: 8:00-11:00 a.m. CT
Abstract Number: 9083

Characterization of time to diagnosis indicates shorter interval for screenable versus symptom-driven cancers
Authors: Gainullin, V., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10526

Comparison of simulated outcomes between stool- and blood-based colorectal cancer screening tests
Authors: Fendrick, A. M., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Poster Discussion: 1:15-4:15 p.m. CT
Abstract Number: 10529

Plasma methylated DNA markers of cutaneous melanoma: Association with PET/CT-positive disease
Authors: Meves, A., et al.
Session: Melanoma/Skin Cancers
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 9567

Methylated DNA markers in urine aid in the selective identification of patients with prostate cancer as well as clinically significant pathology
Authors: Shah, P., et al.
Session: Genitourinary Cancer ‒ Prostate, Testicular, and Penile
Poster Discussion: 3:15-6:15 p.m. CT
Abstract Number: 5091

Online Publications

Cost-effectiveness of mt-sDNA vs mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model
Authors: Bhatt, J., et al.
Abstract Number: e18827

Cost-effectiveness of waiving coinsurance for follow-up colonoscopy after a positive stool-based colorectal screening test in a Medicare population
Authors: Fendrick, A. M., et al.
Abstract Number: e13624

Modeling analysis of COVID 19-related delays in colorectal cancer screening on simulated clinical outcomes
Authors: Wilson, L., et al.
Abstract Number: e13631

Plasma methylated DNA markers detect recurrence and response to therapy in colorectal cancer
Authors: Zhu, M., et al.
Abstract Number: e15567

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing 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 before and 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 and LinkedIn.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score, Oncotype MAP Oncotype DX AR-V7 Nucleus Detect, Oncomap, and Oncomap ExTra, 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.

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. 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.

¹ Cancer Fact Sheet. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed May 13, 2022.
² Fendrick, A. M., et al. Abstract #10529, ASCO 2022.
³ Fendrick, A. M., et al. Abstract #e13624, ASCO 2022.
⁴ Gainullin, V., et al. Abstract #10526. ASCO 2022.
⁵ Meves, A., et al. Abstract # 9567. Shah, P., et al. Abstract # 5091. Witzig, T., et al. Abstract # 7562. ASCO 2022.
⁶ Niu, J., et al. Abstract # 9083. Dombrowski, S., et al. Abstract # 1096. McDonnell, K., et al. Abstract # 3124. ASCO 2022.
⁷ Salem, M., et al. Abstract # TPS3632. ASCO 2022.

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