Developmental Disabilities

Results indicate potential of a minimally invasive screening tool to detect most common form of Esophageal Cancer, a highly treatable cancer if caught early MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, in collaboration with Mayo Clinic Comprehensive Cancer Center, reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard® Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus (BE).1,2 Findings from the test’s algorithm training and testing were recently published in the Clinical Gastroenterology and Hepatology journal. EAC is the most common form of esophageal cancer in the U.S. with incidence having increased significantly over the past few decades compared to other, more common types of cancer where rates have either declined or remained flat due to advanced technologies in screening.3,4 The majority of EAC cases are diagnosed in advanced stages, with early EAC typically having no signs or symptoms, making screening in high-risk populations a critical need.5 There are approximately 30 million people in the U.S. who are at high-risk for EAC and should be screened.6 “Esophageal adenocarcinoma (EAC) is quickly becoming one of the deadliest cancers, with over 80% of patients dying within five years of diagnosis.7 Barrett’s esophagus (BE) is the only known precursor to EAC and patients with BE have an increased risk of progressing to EAC if not caught early. Standard methods of screening can be invasive and costly for patients, which is why there has been a recent push to change the screening guidelines to include non-endoscopic tests,” said Prasad G. Iyer, MD, Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic Comprehensive Cancer Center. “In collaborating with Exact Sciences, we are able to study the potential of a minimally invasive, non-endoscopic screening tool currently in development in patients at higher risk for EAC. Our algorithm training and testing study accomplishes the next critical step for the accurate, non-endoscopic detection of BE/EAC.” The study used an encapsulated sponge collection device to collect esophageal specimens from 352 participants in the training set and 125 participants in the test set. These were then blindly assayed for methylated DNA markers (MDMs). Cross-validation of the three-MDM panel demonstrated an overall sensitivity of 82% (CI, 68% to 94%) for BE detection at 90% specificity (CI, 79% to 98%) in the training set and 88% sensitivity (CI, 78% to 94%) at 84% specificity (CI, 70% to 93%) in the test set. In both training and test sets, sensitivity was 100% for EAC and BE with high grade dysplasia (HGD) – both treatment-eligible subsets. The collection method was generally well tolerated by study participants and was conducive to office-based implementation. “In esophageal cancer, earlier screening and detection will provide an important advance, as we have seen in other cancers. While many experts recommend that people with chronic reflux disease and at least one other risk factor be screened for Barrett’s esophagus, only a small number of eligible patients undergo screening currently,”8 said Paul Limburg, Chief Medical Officer of Screening, Exact Sciences. “At Exact Sciences, our work has always focused on the latest innovations in screening and testing to help patients and clinicians have accurate, less invasive, and cost-effective options. We are collaborating with Mayo Clinic to continue the development of the Oncoguard Esophagus test as a minimally invasive solution for earlier detection of EAC and its precursors.” The Oncoguard Esophagus test is currently under development and features of the test described above are outlining current development goals. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other national regulatory authority. Mayo Clinic and Dr. Iyer have a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research. 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 ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Exact Sciences, Cologuard and Oncoguard are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype is a registered trademark of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners. 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 we make regarding the development and commercialization of the Oncoguard Esophagus test; the performance characteristics and healthcare benefits of the Oncoguard Esophagus test in a commercial setting; and the timing and anticipated results of FDA or any other national regulatory authority submission. 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. 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 we make regarding the development and commercialization of the Oncoguard Esophagus test; the performance characteristics and healthcare benefits of the Oncoguard Esophagus test in a commercial setting; and the timing and anticipated results of FDA or any other national regulatory authority submission. 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. References: Iyer, P. G., Taylor, W. R., et al. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol 2018, 113 (8), 1156-1166. Iyer, P. G.,Taylor, W. R., et al. Accurate Nonendoscopic Detection of Barrett’s Esophagus by Methylated DNA Markers: A Multisite Case Control Study. Am J Gastroenterol 2020, 115 (8), 1201-1209. Cook D, et al. Gastrointest Endosc Clin N Am. 2021 Jan; 31(1): 1–26. Accessed 26 March 2024. He H, et al. Thorac Cancer. 2020 May; 11(5): 1121–1128. Accessed 26 March 2024. Then T E, et al. World J Oncol. 2020 Apr; 11(2): 55–64. Accessed 26 March 2024. Chandar, A.K., Low, E.E., et al. Estimated Burden of Screening for Barrett’s Esophagus in the United States. Gastroenterology. Volume 165, Issue 1, p283-285.E2, July 2023. National Cancer Institute. Cancer Stat Facts: Esophageal Cancer. Accessed 26 March 2024. Eluri S, et al Am J Gastroenterol. 2022 Nov 1; 117(11): 1764–1771. View source version on businesswire.com: Contacts Investor Contact: Nathan Harrill Exact Sciences Corp. investorrelations@exactsciences.com 608-535-8659 For Immediate Release Source: Exact Sciences Corp. View this news release online at:

NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announces that the company will be utilizing the preclinical services program offered by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate RLS-0071 as a medical countermeasure for Acute Radiation Syndrome (ARS). Under a research collaboration, scientists at the Armed Forces Radiobiology Research Institute (AFRRI), working with support from the Radiation and Nuclear Countermeasures Program (RNCP) at NIAID, will evaluate the ability RLS-0071 to mitigate the gastrointestinal effects of ARS (GI-ARS) in a preclinical mouse model. “We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta. “Our collaboration may provide a much-needed therapy for radiation-induced tissue damage that is associated with high mortality.” Dr. Neel Krishna, Chief Scientific Officer at ReAlta adds that, “the anti-inflammatory, dual mechanism-of-action of RLS-0071 enables the rapid inhibition of both complement activation and neutrophil effectors that are key initiators of deadly inflammation in ARS.” About the National Institutes of Health (NIH) As one of the 27 institutes and centers of the U.S. NIH, NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the U.S. and around the world. About AFRRI AFRRI was established in 1961 and operated by the U.S. Defense Atomic Support Agency and the Defense Nuclear Agency until 1993, when it was realigned with the Uniformed Services University of the Health Sciences (USUHS). AFRRI is unique and powerful radiobiological research institute, with six decades of active, robust, and outstanding support to the U.S. Department of Defense through research, reach-back, and education. It is the only U. S. Department of Defense medical R&D facility dedicated solely to nuclear and radiological defense. About Acute Radiation Syndrome ARS, also known as radiation sickness or radiation poisoning, is a collection of health effects that are caused by exposure to high amounts of ionizing radiation in a short period of time. Symptoms can start within minutes of exposure and can last for several months. Early symptoms are usually nausea and vomiting. In the following hours or weeks, initial symptoms may appear to improve, before the development of additional complications, after which either recovery or death follows. Exposure to radiation can occur accidentally or intentionally, and may involve nuclear power reactor accidents or attacks, certain devices used in cancer therapy, dirty bombs, or nuclear or radiological weapons. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit .

For individuals with autism and related intellectual and developmental disabilities, Applied Behavior Analysis (ABA) provides evidence-based tools to navigate their education, engage with their peers, and learn critical life skills. Unlike other behavioral health services, such as substance abuse treatment or mental health counseling, autism and intellectual and developmental disability (IDD) care provides a unique opportunity for our healthcare system and our education system to function together. Through my experience working as a BCBA-D, I have seen firsthand the significant challenges — and immense opportunities — that can occur when these two systems work together. When there is synergy between the two, individuals with autism (who I will refer to as ‘learners’ throughout this piece) and their caregivers can build a foundation of trust and shared understanding with both their clinicians and educators. Given that learners may be receiving services from board-certified behavior analysts (BCBAs) within their school system and privately in the center or home-based services, the coordination of goals and intervention can be disjointed from the clinic to the classroom. By equipping our BCBAs and special educators with streamlined data collection and IEP management tools, we can create collaboration between these systems and promote progress for learners across learning environments. Understanding autism and IDD care A diagnosis for autism and related IDDs is medical, and educators are tasked with the job of translating this diagnosis into a specific Individualized Education Program (IEP) to support a learner’s unique needs. ABA therapy can be delivered in two ways: either by a school-based BCBA or by a private clinician. In either scenario, ABA therapy often requires intensive data collection to drive data-based interventions or individualized academic instruction and behavioral supports. As such, tracking data on skill acquisition and behavior reduction for these learners is critical to understanding and improving their progress toward mastering IEP goals. Encouraging collaboration with policy and technology Managing multiple data collection and IEP management systems can lead to double data entry, manual data graphing processes, potential human error, and ultimately more time spent on the paperwork that could be better spent teaching and building rapport with students. Streamlining special education and ABA-based classrooms with comprehensive systems greatly reduces administrative time and errors, allowing teachers to do more of what matters—providing high-quality instruction. When teachers, therapists, support staff, and special educators leverage technology for data collection, communication, and reporting, collaboration on learner progress is less challenging and less time-consuming. Streamlined systems that both school and clinical teams adopt can lessen the knowledge gap between institutions and increase the likelihood of success for learners in the classroom and beyond.