Latest news with #BrianBaranick


Business Wire
28-05-2025
- 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.
Yahoo
28-05-2025
- 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


Business Wire
22-04-2025
- Health
- Business Wire
Exact Sciences Launches the Oncodetect ™ Molecular Residual Disease Test
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the launch of Oncodetect™—a new test designed to detect molecular residual disease (MRD) across multiple solid tumors. The Oncodetect test provides patients and their healthcare providers with the insights needed to make more informed decisions throughout the treatment process, advancing the field of MRD testing. The Oncodetect test delivers clear "Detected' or 'Not Detected' results, accompanied by quantitative data to help support adjuvant therapy decisions, evaluate treatment response, and monitor cancer recurrence. Notably, patients who test positive for ctDNA with the Oncodetect test during surveillance are 50 times more likely to experience cancer recurrence than those with negative results 1. Highly sensitive and personalized, the test tracks up to 200 tumor-specific variants and identifies even trace amounts of ctDNA—down to 1 ctDNA molecule in 20,000 cfDNA ‡ molecules. This sensitivity enables earlier detection of CRC recurrence compared to imaging alone 1,2. "Exact Sciences is transforming cancer care by delivering tests that provide the clarity patients and physicians need to make confident decisions," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "After surgery and definitive therapy, such as chemotherapy or radiation, the risk for cancer recurrence remains a major concern. Advanced detection tools like the Oncodetect test help bridge that gap by providing clinical insights at critical periods, leading to more informed treatment decisions and personalized care.' Backed by robust clinical validation, including data from the Alpha-CORRECT study—one of the longest-followed MRD cohorts for CRC recurrence with nearly five years of follow-up—the Oncodetect test enhances understanding of cancer recurrence and helps support timely, personalized treatment decisions. Exact Sciences is actively working with Medicare to secure reimbursement for the test, ensuring broad patient access nationwide. The company is also advancing clinical and analytical validation studies across multiple solid tumors, supported by strategic partnerships for multi-cancer evidence generation. 'Exact Sciences is a longtime trusted partner in addressing the critical unmet needs in colorectal cancer care, ensuring patients have the insights they need to navigate treatment with confidence,' said Vanessa Ghigliotty, Certified Patient Navigator & Chair, Patient Advisory Board, GI Cancers Alliance §. 'For those facing the uncertainty of recurrence, tumor-informed MRD tests like the Oncodetect test can provide clear, timely answers—empowering patients to take an active role in their care and receive the right treatment at the right time for better outcomes.' The Oncodetect test builds on 20 years of genomic testing excellence established by the Oncotype DX Breast Recurrence Score ® test. Integrated into a world-class digital experience, supported by the ExactNexus™ technology platform, the Oncodetect test can be ordered with other Exact Sciences tests, including OncoExTra ® (comprehensive genomic profiling) and Riskguard® (hereditary cancer testing). With more than 3 million American patients 3 eligible for MRD testing, Exact Sciences is well-positioned to shape the future of personalized care. The Oncodetect test is now available. For more information, visit * Circulating tumor DNA † The Oncodetect test was clinically validated in colorectal cancer patients with stage II-IV disease. Performance characteristics may not apply in tumor types not included in this test's clinical validation. ‡ Cell-free DNA § Ghigliotty attended the March 2025 Cologuard Classic through a grant from Exact Sciences to the GI Cancers Alliance, which has also received prior funding from the company. References 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. Santonja et al 2023 EMBO ( Data source on file Internal product profile of the Oncodetect test 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 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 (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. Oncodetect, Oncotype, Oncotype DX Breast Recurrence Score, and OncoExTra are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Riskguard are trademarks of Exact Sciences Corporation. Oncodetect, Cologuard, Riskguard, and OncoExTra are 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 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.


Business Wire
22-04-2025
- Health
- Business Wire
Exact Sciences Launches the Oncodetect™ Molecular Residual Disease Test
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the launch of Oncodetect™—a new test designed to detect molecular residual disease (MRD) across multiple solid tumors. The Oncodetect test provides patients and their healthcare providers with the insights needed to make more informed decisions throughout the treatment process, advancing the field of MRD testing. The Oncodetect test delivers clear "Detected' or 'Not Detected' results, accompanied by quantitative data to help support adjuvant therapy decisions, evaluate treatment response, and monitor cancer recurrence. Notably, patients who test positive for ctDNA with the Oncodetect test during surveillance are 50 times more likely to experience cancer recurrence than those with negative results1. Highly sensitive and personalized, the test tracks up to 200 tumor-specific variants and identifies even trace amounts of ctDNA—down to 1 ctDNA molecule in 20,000 cfDNA‡ molecules. This sensitivity enables earlier detection of CRC recurrence compared to imaging alone1,2. "Exact Sciences is transforming cancer care by delivering tests that provide the clarity patients and physicians need to make confident decisions," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "After surgery and definitive therapy, such as chemotherapy or radiation, the risk for cancer recurrence remains a major concern. Advanced detection tools like the Oncodetect test help bridge that gap by providing clinical insights at critical periods, leading to more informed treatment decisions and personalized care.' Backed by robust clinical validation, including data from the Alpha-CORRECT study—one of the longest-followed MRD cohorts for CRC recurrence with nearly five years of follow-up—the Oncodetect test enhances understanding of cancer recurrence and helps support timely, personalized treatment decisions. Exact Sciences is actively working with Medicare to secure reimbursement for the test, ensuring broad patient access nationwide. The company is also advancing clinical and analytical validation studies across multiple solid tumors, supported by strategic partnerships for multi-cancer evidence generation. 'Exact Sciences is a longtime trusted partner in addressing the critical unmet needs in colorectal cancer care, ensuring patients have the insights they need to navigate treatment with confidence,' said Vanessa Ghigliotty, Certified Patient Navigator & Chair, Patient Advisory Board, GI Cancers Alliance§. 'For those facing the uncertainty of recurrence, tumor-informed MRD tests like the Oncodetect test can provide clear, timely answers—empowering patients to take an active role in their care and receive the right treatment at the right time for better outcomes.' The Oncodetect test builds on 20 years of genomic testing excellence established by the Oncotype DX Breast Recurrence Score® test. Integrated into a world-class digital experience, supported by the ExactNexus™ technology platform, the Oncodetect test can be ordered with other Exact Sciences tests, including OncoExTra® (comprehensive genomic profiling) and Riskguard® (hereditary cancer testing). With more than 3 million American patients3 eligible for MRD testing, Exact Sciences is well-positioned to shape the future of personalized care. The Oncodetect test is now available. For more information, visit * Circulating tumor DNA † The Oncodetect test was clinically validated in colorectal cancer patients with stage II-IV disease. Performance characteristics may not apply in tumor types not included in this test's clinical validation. ‡ Cell-free DNA § Ghigliotty attended the March 2025 Cologuard Classic through a grant from Exact Sciences to the GI Cancers Alliance, which has also received prior funding from the company. References 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. Santonja et al 2023 EMBO ( Data source on file Internal product profile of the Oncodetect test 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 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 (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. Oncodetect, Oncotype, Oncotype DX Breast Recurrence Score, and OncoExTra are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Riskguard are trademarks of Exact Sciences Corporation. Oncodetect, Cologuard, Riskguard, and OncoExTra are 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 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.