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Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer
Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer

Yahoo

time09-07-2025

  • Business
  • Yahoo

Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer

MADISON, Wis., July 09, 2025--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period. The final LCD can be found here, and the billing and coding article here, from CMS. This marks a significant milestone in the company's mission to transform cancer treatment through earlier detection and more personalized care. Medicare coverage for colorectal cancer is a step forward to address the more than three million Americans eligible for MRD testing across multiple solid tumors.1 The highly sensitive, tumor-informed assay empowers oncologists and patients with insights during critical moments throughout treatment. The Oncodetect test tracks up to 200 ctDNA variants and can identify signs of cancer recurrence up to two years earlier than imaging alone.2 "Gaining Medicare coverage for the Oncodetect test is a meaningful step forward in expanding access to earlier, more personalized insights for patients with colorectal cancer," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "This decision underscores the clinical value of our MRD test and reinforces Exact Sciences' leadership in advancing tools that support timely, informed treatment decisions." The Oncodetect test is supported by robust clinical validation studies, including Beta-CORRECT—Exact Sciences' largest MRD clinical study to date—which confirms the test's prognostic power across stages II-IV CRC3, and Alpha-CORRECT, one of the longest-followed MRD cohorts for CRC recurrence. Its integration with the ExactNexus™ technology platform enables seamless ordering alongside other Exact Sciences Precision Oncology solutions. Exact Sciences is pursuing additional Medicare coverage across other solid tumor indications, building on this momentum to bring the benefits of MRD testing to more patients. For more information, visit About the Oncodetect test Developed by Exact Sciences, the Oncodetect test is a tumor-informed molecular residual disease (MRD) test designed to provide a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By leveraging the company's expertise in whole exome sequencing, the Oncodetect test analyzes circulating tumor DNA (ctDNA) shed into the bloodstream by tumors, offering critical insights into changes in ctDNA levels over time. This quantitative assessment of ctDNA (measured as MTM/mL) helps healthcare providers better understand a patient's MRD status and make informed treatment decisions4. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company's growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like Oncodetect™ for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit follow @ExactSciences on X, or connect on LinkedIn and Facebook. Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States. References Data source on file. Diergaarde B, Young G, Hall DW, Mazloom A, Costa G, Subramaniam S, Palomares M, Garces J, Baehner FL, Schoen RE; and other members of the Exact Sciences MRD Group. Circulating tumor DNA as a marker of recurrence risk in Stage III colorectal cancer: The α‐CORRECT study. Journal of Surgical Oncology. Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025. Internal product profile of the Oncodetect test. Forward-Looking Statement 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 regarding our expectations for the commercialization of the Oncodetect test and the performance of the Oncodetect test in a commercial setting. 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. View source version on Contacts Media Contact Allison Barry+1 980-297-1957abarry@ Investor Contact Derek Leckow+1 608-893-0009investorrelations@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data

Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer
Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer

Business Wire

time09-07-2025

  • Business
  • Business Wire

Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer

MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period. The final LCD can be found here, and the billing and coding article here, from CMS. This marks a significant milestone in the company's mission to transform cancer treatment through earlier detection and more personalized care. Exact Sciences' Medicare coverage for its Oncodetect™ molecular residual disease (MRD) test in colorectal cancer marks a significant milestone in the company's mission to transform cancer care through earlier detection and more personalized treatment. Share Medicare coverage for colorectal cancer is a step forward to address the more than three million Americans eligible for MRD testing across multiple solid tumors. 1 The highly sensitive, tumor-informed assay empowers oncologists and patients with insights during critical moments throughout treatment. The Oncodetect test tracks up to 200 ctDNA variants and can identify signs of cancer recurrence up to two years earlier than imaging alone. 2 "Gaining Medicare coverage for the Oncodetect test is a meaningful step forward in expanding access to earlier, more personalized insights for patients with colorectal cancer,' said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. 'This decision underscores the clinical value of our MRD test and reinforces Exact Sciences' leadership in advancing tools that support timely, informed treatment decisions." The Oncodetect test is supported by robust clinical validation studies, including Beta-CORRECT —Exact Sciences' largest MRD clinical study to date—which confirms the test's prognostic power across stages II-IV CRC 3, and Alpha-CORRECT, one of the longest-followed MRD cohorts for CRC recurrence. Its integration with the ExactNexus™ technology platform enables seamless ordering alongside other Exact Sciences Precision Oncology solutions. Exact Sciences is pursuing additional Medicare coverage across other solid tumor indications, building on this momentum to bring the benefits of MRD testing to more patients. For more information, visit About the Oncodetect test Developed by Exact Sciences, the Oncodetect test is a tumor-informed molecular residual disease (MRD) test designed to provide a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By leveraging the company's expertise in whole exome sequencing, the Oncodetect test analyzes circulating tumor DNA (ctDNA) shed into the bloodstream by tumors, offering critical insights into changes in ctDNA levels over time. This quantitative assessment of ctDNA (measured as MTM/mL) helps healthcare providers better understand a patient's MRD status and make informed treatment decisions 4. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences (Nasdaq: EXAS) helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company's growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like Oncodetect™ for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit follow @ExactSciences on X, or connect on LinkedIn and Facebook. Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States. References Data source on file. Diergaarde B, Young G, Hall DW, Mazloom A, Costa G, Subramaniam S, Palomares M, Garces J, Baehner FL, Schoen RE; and other members of the Exact Sciences MRD Group. Circulating tumor DNA as a marker of recurrence risk in Stage III colorectal cancer: The α‐CORRECT study. Journal of Surgical Oncology. Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025. Internal product profile of the Oncodetect test. Forward-Looking Statement 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 regarding our expectations for the commercialization of the Oncodetect test and the performance of the Oncodetect test in a commercial setting. 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.

Exact Sciences Expands Oncodetect Validation, Unveils MRD Innovation Roadmap.
Exact Sciences Expands Oncodetect Validation, Unveils MRD Innovation Roadmap.

Yahoo

time23-06-2025

  • Business
  • Yahoo

Exact Sciences Expands Oncodetect Validation, Unveils MRD Innovation Roadmap.

Exact Sciences Corporation (NASDAQ:EXAS) is among the 11 Best Genomics Stocks to Buy According to Hedge Funds. It has released fresh data from the Beta-CORRECT study that validates the clinical efficacy of its tumor-informed Oncodetect™ test for recurrence monitoring in stage II-IV colorectal cancer. A research team in a laboratory discussing the results of a lab screening test for biomarkers. The findings, presented at ASCO 2025, revealed that patients with ctDNA-positive results after therapy and during surveillance had a 24- and 37-fold greater risk of recurrence, respectively. The business also disclosed plans to introduce a next-generation test in 2026 that will use Broad Institute's MAESTRO technology, which can track up to 5,000 patient-specific variations and identify ctDNA levels below 1 part per million. Oncodetect, which was created for molecular residual disease identification, has improved prognosis prediction over standard-of-care approaches in stage III colorectal cancer, as proven by both Alpha- and Beta-CORRECT trials. The revised version uses whole-genome sequencing that is solely licensed from the Broad Institute to improve sensitivity and scalability. This is Exact Sciences Corporation (NASDAQ:EXAS)'s largest MRD clinical research to date, with over 400 patients enrolled, and it reflects the company's ambition to enhance precision oncology through advances based on ctDNA. While we acknowledge the potential of EXAS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™
Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™

Business Wire

time28-05-2025

  • Business
  • Business Wire

Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™

MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect™, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test's role in supporting treatment and surveillance decisions. Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute's MAESTRO technology. Early data show the test will track up 5,000 2 patient specific variants and detect ctDNA * levels below 1 part per million. 1 The test will be available to both new and existing customers in 2026. 'We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that's already being realized,' said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. 'We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility.' The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods †,3,4,5 Data presented at ASCO from the Beta-CORRECT clinical validation study confirm that the Oncodetect test accurately predicts recurrence in stage III colorectal cancer 3 —consistent with findings from the Alpha-CORRECT study —and extends this association to stages II and IV. 4 Exact Sciences' largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively. 4 By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice. 3,4 Advancing the Oncodetect test with next generation innovation The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants 2 with a limit of detection below 1 part per million, 1 enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute's MAESTRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy. This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice. 'The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology,' said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. 'This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes.' * Circulating tumor DNA † Standard of care markers include CEA and clinicopathologic factors References: Edward S. Sim, Justin Rhoades, Kan Xiong, Laurel Walsh, Andjela Crnjac, Timothy Blewett, Yana Al-Inaya, Julia Mendel, Daniel A. Ruiz-Torres, Vasileios Efthymiou, Gjystina Lumaj, William J. Benjamin, G. Mike Makrigiorgos, Shervin Tabrizi, Viktor A. Adalsteinsson, Daniel L. Faden; Early Postoperative Minimal Residual Disease Detection with MAESTRO Is Associated with Recurrence and Worse Survival in Patients with Head and Neck Cancer. Clin Cancer Res 2025; Data source on file. Exact Sciences. Madison, WI. May 2025. Diergaarde B, Young G, Hall DW, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: the α-CORRECT study. J Surg Oncol. Jan 2025. Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025. ASCO 2025 Industry Expert Theater Presentation: Molecular Residual Disease Testing with Exact Sciences' Oncodetect test: Product and Clinical Data Overview. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard ® and Oncotype DX ® 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 follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences and Cologuard are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States. Forward-Looking Statement 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 regarding our expectations for the commercialization of the Oncodetect and next-generation MRD tests, the performance characteristics and health care benefits of the Oncodetect and next-generation MRD tests in a commercial setting, and launch date for the next-generation MRD 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.

Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap
Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap

Yahoo

time28-05-2025

  • Business
  • Yahoo

Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap

Beta-CORRECT study to be presented at ASCO 2025 confirms the clinical utility of the molecular residual disease (MRD) test, Oncodetect™, for recurrence monitoring in stage II–IV colorectal cancer Whole-genome Oncodetect test powered by MAESTRO to launch in 2026 with ultra-low limit of detection1 MADISON, Wis., May 28, 2025--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect™, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test's role in supporting treatment and surveillance decisions. Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute's MAESTRO technology. Early data show the test will track up 5,0002 patient specific variants and detect ctDNA* levels below 1 part per million.1 The test will be available to both new and existing customers in 2026. "We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that's already being realized," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility." The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods †,3,4,5 Data presented at ASCO from the Beta-CORRECT clinical validation study confirm that the Oncodetect test accurately predicts recurrence in stage III colorectal cancer3—consistent with findings from the Alpha-CORRECT study—and extends this association to stages II and IV.4 Exact Sciences' largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively.4 By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice.3,4 Advancing the Oncodetect test with next generation innovation The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants2 with a limit of detection below 1 part per million,1 enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute's MAESTRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy. This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice. "The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology," said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. "This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes." * Circulating tumor DNA † Standard of care markers include CEA and clinicopathologic factors References: Edward S. Sim, Justin Rhoades, Kan Xiong, Laurel Walsh, Andjela Crnjac, Timothy Blewett, Yana Al-Inaya, Julia Mendel, Daniel A. Ruiz-Torres, Vasileios Efthymiou, Gjystina Lumaj, William J. Benjamin, G. Mike Makrigiorgos, Shervin Tabrizi, Viktor A. Adalsteinsson, Daniel L. Faden; Early Postoperative Minimal Residual Disease Detection with MAESTRO Is Associated with Recurrence and Worse Survival in Patients with Head and Neck Cancer. Clin Cancer Res 2025; Data source on file. Exact Sciences. Madison, WI. May 2025. Diergaarde B, Young G, Hall DW, et al. Circulating tumor DNA as a marker of recurrence risk in stage III colorectal cancer: the α-CORRECT study. J Surg Oncol. Jan 2025. Hashimoto et. al: The Association of ctDNA with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT study. Presented at ASCO 2025. ASCO 2025 Industry Expert Theater Presentation: Molecular Residual Disease Testing with Exact Sciences' Oncodetect test: Product and Clinical Data Overview. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype DX® 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 follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences and Cologuard are trademarks of Exact Sciences Corporation. Oncodetect is only available in the United States. Forward-Looking Statement 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 regarding our expectations for the commercialization of the Oncodetect and next-generation MRD tests, the performance characteristics and health care benefits of the Oncodetect and next-generation MRD tests in a commercial setting, and launch date for the next-generation MRD 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. View source version on Contacts Media Contact: Lisa Warshaw+1 323-360-8778lwarshaw@ Investor Contact: Derek Leckow+1 608-893-0009investorrelations@ Sign in to access your portfolio

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