Pancreatic Intraductal Neoplasms

LUND, Sweden, March 24, 2025 /PRNewswire/ - - Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announced additional results from the successful VERIFI study of its next-generation pancreatic cancer test, strengthening the company's position as it prepares to launch the pancreatic cancer blood test commercially. Immunovia's next-generation test detected significantly more cancers than CA19-9, a common biomarker for pancreatic cancer, in the study. The company also announced that the specificity of its test in the VERIFI study was equivalent to CA19-9 and just below the target specificity for the trial. "The Immunovia test accurately classified cancerous and non-cancerous blood samples in the VERIFI study," said Jeff Borcherding, CEO of Immunovia. "The test once again significantly outperformed CA19-9. In addition, combined results from the CLARITI and VERIFI studies make it clear that our next-generation test can accurately detect pancreatic cancer in multiple different groups of high-risk individuals." VERIFI met the primary study endpoint. On March 19 2025, Immunovia announced the VERIFI study met its primary endpoint, with the test successfully detecting 77% of stage I and II pancreatic cancer cases, far exceeding the target of 65%. This sensitivity was significantly better than the sensitivity of CA19-9, which was 69%. Combined data showed strong accuracy across multiple high-risk patient groups. Combined data from the VERIFI and CLARITI validation studies allow for robust analysis of test performance across patient groups at high risk for different reasons. The Immunovia next-generation test demonstrated excellent and consistent sensitivity and specificity across key high-risk groups, including those at risk due to family history of pancreatic cancer or genetic mutations, patients with diabetes, and people with pancreatic cysts: "The combined test performance data from CLARIFI and VERIFI represents a key milestone for Immunovia: demonstrating excellent test accuracy across multiple groups of high-risk patient groups for the first time," said Jeff Borcherding, CEO of Immunovia. "These data bolster our commercial opportunity and expand our addressable market." Specificity in the VERIFI study was in line with target performance and CA19-9. The specificity of the Immunovia test was 88%, compared to the target specificity of 90%. Like the previous CLARITI study, the specificity of the Immunovia test was essentially equal to the specificity of CA19-9 (88% vs. 89%). In the VERIFI study, specificity was a secondary endpoint, not a co-primary endpoint, because the low number of control samples in the study (271) made the quantification of specificity less precise. VERIFI results strengthen and support Immunovia's commercial plans. Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test's clinical impact and further evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption. About the VERIFI Study The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. These were compared to 270 control samples from people without pancreatic cancer classified as high risk. These high-risk individuals had a family history of pancreatic cancer, concerning genetic mutations, pancreatic cysts (fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer), or a combination of these risk factors. About Pancreatic Cancer Pancreatic cancer is one of the most aggressive cancers, with a five-year survival rate of just 13%. Early detection is critical for improving patient outcomes, particularly for individuals at high risk of pancreatic cancer. Individuals with certain genetic mutations or family history of PDAC face higher risk. Certain pancreatic cysts, such as intraductal papillary mucinous neoplasms (IPMNs), also pose a significant cancer risk, with up to 15% progressing to pancreatic cancer within 15 years. For more information, please contact: Jeff Borcherding CEO and President [email protected] Immunovia in brief Immunovia AB (IMMNOV: Nasdaq Stockholm), is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer. Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer. USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing. Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit This information was brought to you by Cision The following files are available for download: SOURCE Immunovia AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LUND, Sweden, Aug. 5, 2024 /PRNewswire/ -- Immunovia (STO: IMMNOV), the pancreatic cancer diagnostics company, today announces that the company's next-generation test to detect pancreatic cancer has been selected for inclusion in a US-government-funded study to evaluate biomarker tests for monitoring cystic tumors of the pancreas. The study's lead author is Diane M. Simeone, an internationally recognized expert in pancreatic neoplasms and the Director of Moores Cancer Center at University of California San Diego Health. The study will assess the use of biomarker tests to detect pancreatic cystic neoplasms (PCNs, or pancreatic cysts) that develop into pancreatic cancer. The overall clinical program will consist of three complementary studies: Study 1 will define the performance and accuracy of blood-based biomarkers through a retrospective study of 200 blood samples that includes early-stage pancreatic cancer cases and controls. Study 2 will evaluate the ability of the biomarker tests to detect early-stage pancreatic cancer in patients undergoing surgery to remove pancreatic cysts suspected to be cancerous. Study 3 will examine biomarker performance for detection of early-stage cancer in a group of individuals undergoing annual surveillance of cystic tumors. The first study should be completed in 2025; the other two will last approximately five years. The study is being funded by a $4.5 million grant from the US National Institutes of Health (NIH). Immunovia's financial commitment will be limited to the company's costs to test the samples received from participating institutions. "Our inclusion in this program makes a strong statement about the promise of Immunovia's next-generation test," said Jeff Borcherding, Immunovia's CEO. "We welcome the opportunity to validate the accuracy of our test and assess its clinical use in collaboration with top experts at leading U.S. multidisciplinary pancreatic centers. This NIH-funded program is a tremendous opportunity to rigorously study our test in patients with pancreatic cystic tumors and generate clinical data at a fraction of what it would cost the company to fund the study on our own." The study will be conducted through four institutions in the PRECEDE Consortium, an international, multi-institutional collaborative group of experts seeking to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those at risk. Dr. Simeone is the principal investigator and executive committee chair of the PRECEDE Consortium. She is also a member of Immunovia's Scientific Advisory Board. "In this grant, our goal is to validate an effective early detection blood test for pancreatic cancer in patients with cystic tumors of the pancreas," said Simeone. "We are eager to work with Immunovia on a blood test that can predict who needs surgery for a pancreatic cyst, and who can be safely monitored without the need for surgery, a critical unmet need for these patients." Pancreatic cystic neoplasms (PCNs) are tumors of the pancreas that are relatively common and have a low, but measurable risk of degeneration into pancreatic cancer. Branch-duct intraductal papillary mucinous neoplasms (IPMN), the most common incidentally discovered PCNs, have a risk of malignancy approaching 15% within 15 years of diagnosis. PCNs can be benign, precancerous or cancerous. Accurate identification of PCNs and determining their risk for progression to invasive pancreatic cancer is important to prevent both overtreatment with unnecessary procedures and missed opportunities for early cancer diagnosis. As previously announced, Immunovia will conduct a large, independent clinical validation study in the fourth quarter 2024 to confirm the accuracy of the Immunovia test in detecting pancreatic cancer in a high-risk population. The company is on track to launch the new test in the United States in 2025. For more information, please contact: Jeff Borcherding CEO and President [email protected] Karin Almqvist Liwendahl Chief Financial Officer [email protected] +46 709 11 56 08 The information in this press release is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07:30 am CET on August 5, 2024. Immunovia in brief Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer. Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer. USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing. Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit  This information was brought to you by Cision The following files are available for download: SOURCE Immunovia AB

SAN DIEGO--( BUSINESS WIRE )--Biological Dynamics, a life sciences company focused on developing and commercializing exosome isolation technology for earlier disease detection, today announced the publication of a case report, “Early detection of pancreatic pre-cancer lesion in multimodal approach with exosome liquid biopsy,” in Frontiers in Oncology , highlighting the successful detection of early-stage pancreatic ductal adenocarcinoma (PDAC) lesions using its exosome liquid biopsy assay, ExoVita TM Pancreas. The case report suggests that the high sensitivity and specificity of the ExoVita Pancreas for early-stage PDAC detection have the potential to improve patient survival outcomes significantly. Pancreatic cancer is currently the third-leading cause of cancer-related death in the United States, 1 with a 5-year survival rate of just 12.5%. 2 The earlier pancreatic cancer is diagnosed and treated, the better the prognosis. Unfortunately, pancreatic cancer usually shows little or no symptoms until it has advanced and spread. As a result, it is often diagnosed in late stages, leaving patients and clinicians with limited treatment options, which lowers the chances of survival. “What is clinically significant about this case report is that the ExoVita Pancreas detected a pancreatic lesion, which has high potential to become malignant very rapidly,” said Harmeet Dhani, M.D., M.Sc., Medical Director of Biological Dynamics. “In this case, our assay, which was initially trained on stage I and II pancreatic cancer patient samples, successfully detected exosomes from an early-stage lesion. This demonstrates the potential to use our assay in conjunction with other diagnostic modalities to help make a diagnosis at very early stages, when treatment is most likely to improve patient outcomes.” The case report profiles a 60-year-old, healthy, non-Hispanic white male who presented with acute pancreatitis. The patient underwent ten months of invasive procedures and testing that failed to detect radiographic evidence of pancreatic lesions or identify disease concerns. However, the ExoVita Pancreas assay resulted in a “high likelihood of PDAC.” Surgical pathology confirmed the diagnosis of high-grade intraductal papillary mucinous neoplasm (IPMN), which was consistent with the ExoVita Pancreas results. Additionally, a post-operative ExoVita Pancreas signature result was not detected, demonstrating that biomarkers had decreased and corroborating the patient’s disease-free clinical picture after a successful surgery. The current standard of care for IPMN patients is a “watch-and-wait” approach that includes invasive, frequent scans and chronic symptom monitoring. Adding ExoVita Pancreas could allow physicians to more confidently direct patient treatment options for both high and low-risk patients. Early data demonstrate the ability to use Biological Dynamics’ ExoVerita exosome isolation platform to detect cancer earlier using a new generation of biomarkers and technology, which is especially important for high-risk patients. The ExoVita Pancreas test, which targets and isolates exosomes found in patient blood samples, detected cancer at stages I and II with high sensitivity and specificity in prior studies, and now has the potential to detect precancerous lesions as well. About Biological Dynamics Biological Dynamics, Inc. is committed to improving global health outcomes by detecting diseases at the earliest stages. Its proprietary exosome-isolation ExoVerita™ platform, currently used by the company and research customers, simplifies isolation of extracellular vesicles, enabling multiomic applications. Biological Dynamics recently initiated its ExoLuminate study to demonstrate the effectiveness of its ExoVita™ Pancreas assay for early-stage detection of pancreatic cancer. The assay is a lab-developed test (LDT) validated and performed in the Company’s College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. All clinical decision making remains with patient and their physicians. Learn more at www.ExoLuminate.com . References: American Cancer Society: Cancer Facts & Statistics. American Cancer Society | Cancer Facts & Statistics . https://cancerstatisticscenter.cancer.org . Accessed May 17, 2023. Cancer Stat Facts: of the pancreas – Pancreatic Cancer. National Cancer Institute. SEER. https://seer.cancer.gov/statfacts/html/pancreas.html . Accessed May 17, 2023.