Latest news with #ExactSciences
Business Wire
7 days ago
- 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.
Yahoo
7 days ago
- 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
Yahoo
27-05-2025
- Business
- Yahoo
Exact Sciences to Participate in June Investor Conference
MADISON, Wis., May 27, 2025--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that company management will participate in the following conference and invited investors to participate by webcast. William Blair 45th Annual Growth Stock Conference, ChicagoPresentation on Tuesday, June 3, 2025 at 9:40 a.m. ET The webcast can be accessed in the investor relations section of Exact Sciences' website at 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 follow Exact Sciences on X @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. View source version on Contacts Derek LeckowExact Sciences 608-893-0009 Sign in to access your portfolio
Business Wire
27-05-2025
- Business
- Business Wire
Exact Sciences to Participate in June Investor Conference
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that company management will participate in the following conference and invited investors to participate by webcast. William Blair 45th Annual Growth Stock Conference, Chicago Presentation on Tuesday, June 3, 2025 at 9:40 a.m. ET The webcast can be accessed in the investor relations section of Exact Sciences' website at 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 follow Exact Sciences on X @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.
Yahoo
22-05-2025
- Health
- Yahoo
Exact Sciences Highlights Innovations in Early Cancer Detection and Precision Oncology at ASCO 2025
MADISON, Wis., May 22, 2025--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill. Presentations include new data on the Oncodetect™ molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score® test, and the Cologuard® test that underscore Exact Sciences' expanding portfolio and commitment to advancing care through scientific excellence. "The data Exact Sciences will present at ASCO 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline," said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. "From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision." Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX® test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening. New Data and Continuous Evidence Generation Underscore the Oncodetect Test's Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings. New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences' MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard™ EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection. Exact Sciences abstracts at ASCO include: Precision Oncology The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3590 Molecular Residual Disease (MRD) in Solid Tumors Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: TPS3186 Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study Abstract number: e15600 Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 601 Screening Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3630 A decade of progress: Trends in 5-year survival across 17 cancer types Abstract number: e23262 The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: 10542 Falcon – Exact Sciences' multi-cancer early detection (MCED) real-world evidence (RWE) registry Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: TPS11189 Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 6057 Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing Abstract number: e17617 References Hashimoto et al. The association of ctDNA with recurrence in patients with stage II-IV colorectal cancer: The β-CORRECT study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. Chhatwal, J., Xiao, J., ElHabr, A., Tyson, C., Cao, X., Raoof, S., Fendrick, A. M., Ozbay, A. B., Limburg, P., Beer, T. M., Deshmukh, A., & Briggs, A. (2025). The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 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. NOTE: Oncotype DX Breast Recurrence Score and Oncodetect are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences. 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 the performance characteristics and health care benefits of the Cologuard, Oncotype DX Breast Recurrence Score, Oncodetect, and Cancerguard EX tests in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences' pipeline tests. 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 Warshaw323-360-8778Lwarshaw@ Investor Contact: Derek Leckow608-893-0009investorrelations@ Sign in to access your portfolio
