Exact Sciences Lab and OncoExTra Test Selected by National Cancer Institute for ComboMATCH Clinical Trials

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Aug 30, 2023

PR Newswire

ComboMATCH trials will use Exact Sciences' new OncoExTra™ therapy selection test to analyze tumor samples for participants in this large precision medicine initiative

Participation in trials reinforces company's commitment to enable delivery of personalized cancer care

MADISON, Wis., Aug. 30, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the National Cancer Institute (NCI) has selected the company's testing laboratory in Phoenix, AZ to participate in the ComboMATCH clinical trials, one of the NCI-funded precision medicine initiatives. As a ComboMATCH-designated lab, Exact Sciences will use its new OncoExTra™ test to analyze tumor tissue and paired normal blood samples from patient participants and uncover the specific abnormalities in a patient's tumor that may be most effective to treat. OncoExTra is a comprehensive next-generation sequencing (NGS) test that provides a comprehensive molecular picture of the patient's cancer and actionable results, matching a patient's unique cancer to a targeted therapy or clinical trial.

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The ComboMATCH registration trial is the gateway to a set of clinical trials evaluating new anti-cancer treatment combinations directed by NGS testing in select groups of adults and children with locally advanced or advanced (metastatic) cancer.

"Most cancers do not have a single underlying cause or driver; so, no single targeted therapy is likely to work, especially in the long-term given the challenge of drug resistance," said James M. Ford, M.D., Stanford University School of Medicine, co-leader of ComboMATCH and leader of the coordination effort by the ECOG-ACRIN Cancer Research Group. "Mounting evidence demonstrates the important role of genomic profiling to guide therapeutic choices when treating cancer, and offers the potential for greater patient benefit, paving the way to new frontiers in cancer treatment."

"The ComboMATCH trials will use our OncoExTra test to provide the most informed picture of a patient's individual tumor biology. We are eager to work with trial investigators and are proud the NCI chose Exact Sciences for this important initiative," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Our company is dedicated to providing comprehensive tumor information for patients in clinical trials like ComboMATCH, and to enabling the delivery of personalized cancer care."

The OncoExTra test profiles the entire exome (DNA) and the transcriptome (RNA) across approximately 20,000 genes, uncovering variants possibly missed by only evaluating DNA. It also uses matched tumor-normal sequencing to limit potentially false positive results and allow physicians to make clinical decisions based on variants related only to the tumor. The American Society of Clinical Oncology (ASCO) has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA, multigene panel test. OncoExTra also analyzes all National Comprehensive Cancer Network® (NCCN®) recommended genes for patients with solid tumors and provides expertly curated, intuitive reports.

For more information about the OncoExTra test, visit precisiononcology.exactsciences.com.

About ComboMATCH

A unique initiative to test new combinations of cancer drugs guided by tumor biology, ComboMATCH (Molecular Analysis for Combination Therapy Choice) is a coordinated set of precision medicine cancer clinical trials led by the ECOG-ACRIN Cancer Research Group and National Cancer Institute (NCI), part of the National Institutes of Health, through the NCI's National Clinical Trials Network (NCTN). ComboMATCH includes participation by the other NCTN groups in the United States, which include the Alliance for Clinical Trials in Oncology, Children's Oncology Group, NRG Oncology, and SWOG Cancer Research Network. To learn more about ComboMATCH, visit https://ecog-acrin.org/combomatch and https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/combomatch.

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 Breast Recurrence Score test is recognized as a 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, the OncoExTra test is one of the most comprehensive molecular tests available to patients today. 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 by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.

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 Twitter @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, Recurrence Score, and OncoExTra are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks 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. 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.

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