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Exact Sciences Launches Riskguard™ Hereditary Cancer Test in the U.S.

On February 27, Exact Sciences Corp., 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. Exact Sciences is a leading provider of cancer screening and diagnostic tests.

“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.

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