Exact Sciences Launches Riskguard™ Hereditary Cancer Test in the United States

The Riskguard test detects genetic changes that can increase risk for 10 common cancers, using a simple blood or saliva sample

The test is covered by Medicare and many commercial insurance plans for eligible patients

Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, today announced the launch of the Riskguard™ hereditary cancer test in the United States. The Riskguard test provides an individualized patient report that includes gene specific and familial risks using a simple blood or saliva sample for 10 common cancers, including colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney and endocrine.

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Riskguard hereditary cancer test (Graphic: Business Wire)

“Riskguard is a genetic test that can help patients understand their risk of developing certain cancers to inform screening, treatment and risks to other family members,” said Brandie Leach, MS, CGC, Senior Director, Medical Affairs at Exact Sciences and former head of a National Cancer Institute (NCI)-designated comprehensive cancer center’s Hereditary Cancer program. “We believe that helping people to identify their risks – and take informed actions to reduce those risks – is a crucial step to help eradicate cancer and the suffering it causes. This will become an increasingly important tool in the primary care setting as well. Offering more effective personalized screening solutions supports Exact Sciences’ commitment to help detect cancer earlier.”

For patients already diagnosed with cancer, knowing about certain gene variants can help create individualized treatment plans for patients. The Riskguard test also helps inform the risk stratification for patients who have a family history of cancer by identifying changes in cancer-associated genes. These actionable results help health care providers better understand their patients’ risk level and management options, leading to more personalized care.

“Recently updated guidelines now recommend germline mutation testing for patients with breast cancer. We are proud to add the Riskguard test to our growing portfolio of innovative offerings – including the Oncotype DX^® and OncoExTra^® tests – that help improve outcomes^1,2 across the cancer-care continuum,” said Brian Baranick, general manager of Precision Oncology at Exact Sciences. “We are also seeing more physician interest in combining tests like Riskguard with therapy selection tests such as OncoExTra to develop a more complete understanding of a patient’s tumor at the molecular level.”

The Precision Oncology commercial team will bring the Riskguard test to health care professionals. Most oncologists in the U.S. have ordered Oncotype^® tests, and physicians can now order all three tests from a single Exact Sciences portal, streamlining the management and treatment for both early stage and late-stage patients.

The Riskguard test is a multi-cancer multigene panel that provides a report on variants in genes that are actionable and are included in an easy-to-understand report with potential care options to support treatment discussions.

Exact Sciences’ customer care teams are available to help patients explore the testing process and understand possible results and outcomes. Genetic counselors are also available to help health care providers interpret results and review medical management options.

As new relevant data becomes available about genes, cancer risk or medical management, Exact Sciences will also continue monitoring genetic research for critical changes and provide updates that impact patients after the initial report.

The Riskguard test is covered by Medicare and many commercial insurance plans for eligible patients. For more information on the Riskguard test, visit https://www.exactsciences.com/Our-Tests/riskguard. Health care providers can order the Riskguard hereditary cancer test beginning March 12, 2024 through the portal found here: precisiononcology.exactsciences.com

The Riskguard test and its performance characteristics are validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is processed in Marshfield, WI at PreventionGenetics, an Exact Sciences laboratory qualified to perform high-complexity clinical laboratory testing that has been providing quality genetic testing since 2004 and joined Exact Sciences in 2022. Revenue from the Riskguard test will be reported as Screening revenue. The Riskguard test has not been cleared or approved by the US Food and Drug Administration or other notified regulatory authority.

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 test of approximately 20,000 genes and 169 introns, 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 X, formerly known as Twitter @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Exact Sciences, Cologuard and Riskguard are trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score 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 commercialization of the Riskguard test; the performance characteristics and clinical utility; and the market acceptance and commercial success of the Riskguard test. 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 _{Domchek SM, Friebel TM, Singer CF, et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA. 2010;304(9):967-975. doi:10.1001/jama.2010.1237}

_{² Dominguez-Valentin M et al, Mortality by age, gene and gender in carriers of pathogenic mismatch repair gene variants receiving surveillance for early cancer diagnosis and treatment: a report from the prospective Lynch syndrome database. EClinicalMedicine. 2023 Mar 20;58:101909}

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