Latest news with #BroadInstitute
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.
Business Wire
15-05-2025
- Business
- Business Wire
Argonaut Manufacturing Services Selected to Manufacture siRNA Medicines for Potential Prion Disease Trial
CARLSBAD, Calif.--(BUSINESS WIRE)--The Vallabh/Minikel lab at the Broad Institute has selected Argonaut Manufacturing Services, Inc., 'Argonaut,' as the drug product manufacturer for a therapeutic compound for a potential clinical trial for prion disease. The Vallabh/Minikel lab has received FDA clearance for the compound, a divalent short interfering RNA (siRNA) intended for delivery via intrathecal injection, as an Investigational New Drug for symptomatic patients with prion disease. The team is now pursuing efforts to launch a clinical trial using this compound. Prion disease, a rare but devastating neurodegenerative condition, is caused by the misfolding of the prion protein (PrP) and leads to rapid cognitive decline and death. Approximately 500 new cases are diagnosed each year in the United States. The investigational siRNA therapeutic is designed to hybridize with the mRNA encoding PrP, thereby reducing PrP expression levels and potentially altering the course of the disease. The Vallabh/Minikel lab is committed to advancing therapeutic options for patients with prion disease. 'We are proud to support the Broad Institute's groundbreaking clinical trial efforts by providing critical manufacturing services for this important therapeutic candidate,' stated Argonaut CEO Rick Hancock. 'Our collaboration underscores Argonaut's commitment to advancing innovative treatments for rare and life-threatening diseases. While Argonaut provides clinical to commercial manufacturing of drug products, this partnership highlights the flexibility of our services, where it is critical to achieve maximum fill efficiency as every drop of this product counts.' The project highlights Argonaut's specialized capabilities in the manufacture of complex RNA therapeutics with near zero line losses, reinforcing its role as a trusted CMO partner for organizations pursuing novel genetic medicines. Learn more about prion disease and the upcoming work from the Vallabh/Minikel lab to potentially launch a clinical trial. About Argonaut Argonaut Manufacturing Services, Inc. is an FDA-registered cGMP contract manufacturing organization (CMO) dedicated to providing custom manufacturing and supply chain solutions for biopharmaceutical and diagnostic companies. Aseptic drug fill/finish features state-of-the-art automated equipment for high-yield filling of sterile injectable drugs including biologics, peptides, small molecule, and vaccines. Diagnostic manufacturing includes proprietary lyophilization technology and a spectrum of kitting capabilities. Projects are supported with full analytical quality control services including warehousing and global shipping logistics. Serving innovators in the life science, molecular diagnostics, and biopharma industries, Argonaut provides a wide range of flexible solutions for diverse outsourcing needs.
San Francisco Chronicle
13-05-2025
- Science
- San Francisco Chronicle
UC Berkeley wins chance to reclaim lucrative gene editing patent
With potentially huge sums at stake, a federal court on Monday reinstated UC Berkeley's legal claim seeking nationwide rights to develop and market gene editing, the transfer of genetic technology between living organisms with the capability of curing diseases. The U.S. Patent Trial and Appeal Board ruled in 2022 that the patent for so-called CRISPR technology belonged to the Broad Institute, affiliated with Harvard and the Massachusetts Institute of Technology, which had published a study in 2012 describing how the technology could be used to alter genes in plants and animals. The board rejected a competing claim from the University of California, whose scientists had reported on the use of CRISPR technology to alter DNA six months before the Broad study. The patent board said the UC Berkeley report was the first of its kind but did not apply directly to genes in plants and animals. But the U.S. Court of Appeals for the Federal Circuit ruled Monday that UC had presented evidence that its findings could be developed and applied to genes in all living creatures. The patent board cited the UC scientists' 'experimental difficulties and … statements of doubt' about the application of their newly discovered technology, but failed to consider evidence that 'routine methods or skill' could enable the scientists to clear those hurdles and show that they were the original source of the information, Judge Jimmie Reyna wrote in the 3-0 ruling. The court ordered the patent board to reconsider UC's contention that its study was the original breakthrough. 'This could end up being a big windfall for the University of California,' said Jacob Sherkow, a professor of law and medicine at the University of Illinois who has followed the issue for more than a decade. He said the Broad Institute was paid $400 million in one of its first contracts with companies seeking to license the CRISPR technology. That contract and others already signed are not at risk, Sherkow said, but if Broad loses the patent, 'no one will sign a future license with them.' Jeff Lamken, an attorney for UC in the case, said the ruling would enable the patent board to 're-evaluate the evidence under the correct legal standard and confirm what the rest of the world has recognized: that the (UC scientists) were the first to develop this groundbreaking technology for the world to share.' The Broad Institute said in a statement that it was 'confident' the patent board 'will reach the same conclusion and will again confirm Broad's patents, because the underlying facts have not changed.' The UC team was led by biochemist Jennifer Doudna and also included French scientist Emmanuelle Charpentier. In 2020, those two won the Nobel Prize in chemistry for their research on CRISPR, the first time two or more women had won that prize without a male partner. In its 2022 ruling, the patent board cited Doudna's statement that the UC study had one shortcoming: 'We weren't sure if (the technology) would work in eukaryotes,' the cells found in plants and animals. The board noted that the scientists had experienced several failures in experiments with fish and human cells, and concluded that – unlike the Broad Institute study six months later – UC's report was 'not yet a definite and permanent reflection of the complete invention as it (would) be used in practice.' But the appeals court said the patent board should have allowed UC to show that its scientists had made the crucial findings in their 2012 report and could take the final steps by using ordinary scientific methods and skills.
Reuters
12-05-2025
- Health
- Reuters
Nobel Prize winners convince court to revive CRISPR patent dispute
May 12 (Reuters) - The University of California and the University of Vienna on Monday convinced a U.S. appeals court to revive their bid for patent rights to groundbreaking CRISPR gene-editing technology created by their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. The decision, opens new tab by the U.S. Court of Appeals for the Federal Circuit was a win for the schools in a long-running dispute over CRISPR patent rights with the Broad Institute, a joint venture of Harvard University and the Massachusetts Institute of Technology. The U.S. Patent Office had previously determined that Broad Institute scientists conceived the technology before Doudna and Charpentier. The Federal Circuit on Monday said that the office had misapplied federal law on patent conception and sent the case back to the Patent Office's Patent Trial and Appeal Board for reconsideration. A Broad Institute spokesperson said the institute was confident that the board will "again confirm Broad's patents, because the underlying facts have not changed." Spokespeople and an attorney for the University of California and the University of Vienna did not immediately respond to a request for comment. CRISPR enables scientists to use biological "scissors" to edit DNA. The technology is being tested in clinical trials to help cure diseases caused by genetic mutations and abnormalities. The University of California's Doudna and Charpentier of the University of Vienna were first to seek a CRISPR patent in 2012. They shared the Nobel Prize in Chemistry for their CRISPR work eight years later. The Broad Institute applied for its own patent covering the use of CRISPR in "eukaryotic" plant or animal cells in 2013 and received the patent in 2014. Doudna, Charpentier and their universities challenged the institute at the Patent Trial and Appeal Board, arguing they came up with the same invention first. The board determined in 2022 that the Broad Institute was entitled to the patent rights, finding that the challengers had not created CRISPR technology that works with eukaryotic cells before the institute invented it. The universities argued in the appeal that their teams "conceived of and described every element of the invention before the Broad Institute's first alleged conception." The Federal Circuit ruled for the Broad Institute in a related case in 2018. The case is Regents of the University of California v. Broad Institute, U.S. Court of Appeals for the Federal Circuit, No. 22-1653. For the universities: Jeffrey Lamken of MoloLamken For the Broad Institute: Raymond Nimrod of Quinn Emanuel Urquhart & Sullivan Read more: Breakthrough gene-editing technology belongs to Harvard, MIT -U.S. tribunal
Yahoo
05-05-2025
- Business
- Yahoo
Editas Medicine to Announce First Quarter 2025 Financial Results and to Participate in Investor Conference in May
CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company focused on developing transformative medicines for serious diseases, today announced that it plans to announce Q1 2025 financial results and business updates on May 12 via press release and SEC filings. As previously announced, the Company does not plan to host quarterly financial results conference calls moving forward. Additionally, Editas Medicine management will participate in the following upcoming investor conference in May: Bank of America Global Healthcare Conference Format: Fireside ChatDate: Tuesday, May 13Time: 5:15 p.m. PTLocation: Las Vegas, NV To access the live webcast of Editas Medicine's presentation, please visit the 'Investors' section of the Company's website at An archived replay will be available for approximately 30 days following the event. About Editas MedicineAs a pioneering gene editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of transformative in vivo medicines for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize durable, precision in vivo gene editing medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute's Cas12a patent estate and Broad Institute and Harvard University's Cas9 patent estates for human medicines. For the latest information and scientific presentations, please visit CONTACT: Media and Investor Contact: ir@ in to access your portfolio
