Latest news with #PrecisionOncology
Yahoo
09-07-2025
- 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
Fast Company
03-07-2025
- Health
- Fast Company
New AI outlines lung tumors better and faster than doctors, study finds
Scientists have developed a revolutionary new AI tool which, according to a new study, may become crucial in lung cancer screening and treatment. The study, published in the journal npj Precision Oncology, explored the capabilities of a new device, developed by a team at Northwestern Medicine. The device is called iSeg, which comes from its ability to perform tumor segmentation (online or mapping tumors). The traditional process of tumor segmentation is complex and poses challenges for doctors. It can also take multiple doctors visits, several scans, and a great deal of time. In one study, manual segmentation required 12 scans and took doctors seven hours to complete the manual tumor mapping. Other AI tools have been developed for cancer screenings, however, those tools used static images. iSeg uses 3D imagery for a deeper understanding of the tumor, including how it moves as a patient breathes—an important factor in determining treatment plans. iSeg's clearer mapping also means it exposes areas that doctors may miss while using manual segmentation. In the study, after the AI was trained, iSeg was shown scans it had never seen, and was tasked with outlining tumors. When compared to outlines drawn by physicians, iSeg matched experts' drawings, but it also flagged additional areas that doctors couldn't see. Interestingly, those areas turned out to be critical, as they are often linked to more serious diagnoses and worse outcomes if overlooked. 'We're one step closer to cancer treatments that are even more precise than any of us imagined just a decade ago,' said Dr. Mohamed Abazeed, senior author of the study, and chair and professor of radiation oncology at Northwestern University Feinberg School of Medicine. 'The goal of this technology is to give our doctors better tools,' added Abazeed. Other experts say AI technology is important when it comes to lung cancer patients, not only because it can save lives, but also because it may help close care gaps that lead to underdiagnosing for certain groups due to socioeconomic factors. Pulmonologist Stephen Kuperberg, MPH '24, and David Christiani, Elkan Blout Professor of Environmental Genetics at Harvard T.H. Chan School of Public Health, explained in a June commentary that cancer screening rates are lower among high-risk patients from Black and Latinx neighborhoods. 'The underlying reasons for poor uptake within this population are complex, including structural racism and social and cultural factors,' they wrote, urging the 'vital need' for more AI tools which can help with 'optimal data collection.' Currently, the glaring gap in early detection leads to higher mortality from the disease for those groups. They added, 'AI technologies will transform reporting, collecting, and processing population data, whether in public datasets and repositories or within institutions, paving the way for discovery and methodology development in lung cancer detection.'
