ClearNote Health Avantect ® Pancreatic Cancer Test Enters Patient Enrollment Phase of Groundbreaking UK Study Targeting High-Risk Patients

SAN DIEGO--(BUSINESS WIRE)-- ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced initiation of patient enrollment for a landmark clinical study utilizing its Avantect ® Pancreatic Cancer Test. Sponsored by University Hospital Southampton NHS Foundation Trust, the prospective, multicenter study seeks to improve early detection of pancreatic cancer in individuals recently diagnosed with type 2 diabetes. With up to 15,000 patient participants, it will be the largest study of its kind.
"We're thrilled to be part of this transformative study that could redefine how pancreatic cancer is detected and managed for patients at high risk due to a recent diabetes diagnosis," said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health.
Patients with newly diagnosed type 2 diabetes are up to eight times as likely to develop pancreatic cancer as the general population. 1 In some of these cases, the diabetes symptoms may be caused by cancer affecting the function of the pancreas, which is responsible for insulin production.
The new Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study is led by Zaed Hamady, consultant pancreatic cancer surgeon at University Hospital Southampton. The single-blind, randomized controlled study will be conducted by researchers at the Southampton Clinical Trials Unit (CTU), based at the University of Southampton in the United Kingdom. The study will provide additional prospective validation data of the Avantect test and help identify early pancreatic cancer signals where present in this high-risk population.
'New onset diabetes has been linked to a six- to eight-fold increase in pancreatic cancer risk,' said Mr. Hamady. 'This patient group provides a valuable opportunity to better understand the exact relationship between these diseases and further validate ClearNote Health's blood-based Avantect Pancreatic Cancer Test, which has the potential to benefit thousands of people in the UK.'
Dr. Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit, emphasized the study's community-focused approach. 'We recognize that access to healthcare and clinical trials is often uneven,' she said. 'By conducting the SAFE-D study through local research hubs and community hospitals, we aim to make early cancer detection research more inclusive and equitable.'
'We are proud to sponsor this cutting-edge study, which holds tremendous potential to improve outcomes for patients facing this devastating disease,' said Dr. Mikayala King, Research and Development Governance, Quality Assurance and Sponsorship Manager at University Hospital Southampton NHS Foundation Trust. 'Our collaboration with ClearNote and the CTU builds on a strong foundation of excellence in cancer research.'
The Avantect Pancreatic Cancer Test is an innovative blood test designed for individuals at elevated risk of pancreatic cancer — particularly those over age 50 who are newly diagnosed with type 2 diabetes, individuals with a family history of the disease, or those with a genetic predisposition. The test analyzes the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA, combined with other genomic data, to detect pancreatic cancer at its earliest and most treatable stages. Unlike conventional methods, ClearNote's approach provides a deeper understanding of the underpinnings of cancer development to inform the next steps in a patient care pathway.
'Early detection is the key to saving lives from the deadliest cancers,' said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. 'We intend to demonstrate that the Avantect test can identify pancreatic cancer in stages I and II, and we're thrilled to be part of this transformative study that could redefine how pancreatic cancer is detected and managed for patients at high risk due to a recent diabetes diagnosis.'
For more information on the SAFE-D study, please visit www.safe-d.uk/about-the-study.
For more information on the Avantect Pancreatic Cancer Test, please visit www.avantect.com.
About ClearNote Health
ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company's highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn.
References
1. Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi:10.1016/j.gastro.2005.05.007.

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16 hours ago

• Business Upturn

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In the STEP UP trial, the higher dose of Wegovy® (semaglutide 7.2 mg) demonstrated a mean weight loss of 21%, with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1 'The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide's established safety profile. This may offer another option to people who do not attain their weight goals,' said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. 'We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.' STEP UP co-primary endpoints at 72 weeks *1 : semaglutide 7.2 mg semaglutide 2.4 mg PlaceboWeight loss 20.7% 17.5% 2.4% 5% or more weight loss 93.2% 92.5% 35.7% When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo. 'With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. This includes maximising the value of semaglutide for individuals, healthcare systems and society, and developing a new oral formulation of Wegovy® that, pending FDA approval, can become the first GLP-1 pill to offer double-digit weight loss.' In the STEP UP trial, semaglutide 7.2 mg demonstrated a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.1 The most common adverse events were gastrointestinal, and the vast majority were mild to moderate during dose escalation and diminished over time, consistent with the GLP-1 class.1 In STEP UP, 3.3% of people treated with semaglutide 7.2 mg discontinued due to gastrointestinal adverse events, compared to 2.0% with semaglutide 2.4 mg and 0% with placebo.1 Novo Nordisk expects to file the higher dose of Wegovy® for a label update in the EU in the second half of 2025, followed by regulatory submissions in other markets where Wegovy® is already approved. 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About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References Wharton, S, et al. (2025). Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. 1966-LB poster. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025.17. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.

Yahoo

a day ago

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argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy

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Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercialising the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. Contacts Media:Kate Dion kdion@ Investors: Alexandra Royaroy@ Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'is,' 'can,' 'may,' 'will,' and 'believe' and include statements argenx makes concerning argenx's aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its belief that the approval of VYVGART SC for the treatment of CIDP may bring meaningful functional improvements to patients; the timing of access to an effective novel therapy for CIDP patients and physicians across Europe; and the potential of efgartigimod in IgG-mediated autoimmune diseases. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. 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Business Wire

2 days ago

• Business Wire

Mirion Medical to Debut New Solutions, Highlight Broad Radiopharma-Focused Portfolio at SNMMI Annual Meeting

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