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Immunovia reported significant achievements in 2024 and outlined plans for 2025. The company successfully developed and validated its next-generation pancreatic cancer detection test, achieving 94% specificity and 78% sensitivity in a large clinical validation study of 1,066 blood samples. The test outperformed CA19-9 biomarker by 14 percentage points and showed even better results (83% sensitivity, 96% specificity) in more recent samples.
For 2025, Immunovia plans to launch the test in the US during the second half of the year, targeting medical centers with high-risk pancreatic cancer surveillance programs. The company is seeking strategic partnerships with large diagnostics companies to accelerate commercialization and will conduct additional clinical studies to secure reimbursement.
Immunovia, Inc. has secured Clinical Laboratory permits from the Pennsylvania and Maryland Departments of Health, enabling physicians in these states to order the IMMray™ PanCan-d test for early pancreatic cancer detection. This permits expansion, now allowing the test to be offered in 48 US states. CEO Jeff Borcherding noted the importance of enhancing pancreatic cancer surveillance. The IMMray™ PanCan-d test is the only blood test available specifically for this purpose and aims to improve survival rates in high-risk patients.
Immunovia is set to launch the IMMray™ PanCan-d test in the US as a Laboratory Developed Test (LDT) in Q2 2021. The company is pursuing a positive Medicare coverage determination via the Local Coverage Determination (LCD) process, aiming for coverage that aligns with existing surveillance imaging modalities for high-risk pancreatic cancer patients. Immunovia anticipates securing agreements with a majority of U.S. payers by year-end 2022, supported by ongoing clinical studies, including PanFAM-1. This innovative test targets early diagnosis of pancreatic ductal adenocarcinoma.
Immunovia announced enhanced performance of its IMMray™ PanCan-d test in detecting early-stage pancreatic cancer among high-risk patients with non-specific symptoms. The clinical study demonstrated a 92% specificity and 81% sensitivity for detecting pancreatic cancers across all stages. The study analyzed 433 samples, including 202 PDACs (89 at stages I/II). The results support the commercialization strategy, targeting a potential market of 1-2 million patients in the USA and Europe. This development is pivotal for improving diagnosis and patient outcomes.
Immunovia's PanFAM-1 study, the largest of its kind for early diagnosis of familial/hereditary pancreatic cancer, has successfully enrolled 1,265 subjects and collected over 3,000 blood samples. The study, aimed at validating the IMMray™ PanCan-d blood test, concluded new enrollment on October 30, 2020, and will finalize blood sample collection by April 2021. Results will be analyzed in the latter half of 2021. This multicenter study includes 23 partners from the USA and Europe, focusing on improving early detection and clinical performance data for at-risk individuals.
Immunovia AB announces the resignation of Chief Technology Officer, Dr. Peter Schultz-Knappe, effective August 31, 2020. Hans Christian Pedersen, previously Vice-President of Business Development, will take on expanded responsibilities as Vice President of Strategy and Business Development. This transition aims to support the upcoming Q4 2020 launch of the IMMray™ PanCan-d test, which is designed for early pancreatic cancer detection. The company is prepared to enhance its commercialization efforts as it approaches this significant milestone.
Immunovia AB will host its second webinar on the IMMray™ PanCan-d on September 2, 2020, at 16:00 CET. The webinar will discuss the results from the Commercial Test Model Study and provide updates on the launch activities of the IMMray™ PanCan-d test, designed for early pancreatic cancer detection. Presenters include experts Linda Mellby, Thomas King, and Laura Chirica. The IMMray™ PanCan-d is in its final validation phase and aims for market launch in Q4 2020, potentially becoming the first blood-based pancreatic cancer diagnostic tool.
Immunovia reported its second quarter results for January to June 2020, emphasizing resilience amid COVID-19 challenges. The company plans to launch the IMMray™ PanCan-d test for early pancreatic cancer detection by Q4 2020. A significant capital raise of approximately SEK 400 million was completed, aiding commercialization efforts. The quarter saw the reopening of the Marlborough laboratory, which had faced operational delays due to the pandemic. Immunovia remains committed to its mission, recently engaging stakeholders through a virtual investment day.
Immunovia AB announced a second webinar about its IMMray™ PanCan-d product, scheduled for September 2, 2020, at 16:00 CET. This session will discuss results from the Commercial Test Model Study and provide updates on launch activities. Presenters include Linda Mellby (PhD), Thomas King (MD, PhD), and Laura Chirica (PhD). A live Q&A will follow the webinar. Access details will be shared on August 27, 2020. IMMray™ PanCan-d aims to be the first blood test for early pancreatic cancer detection, enhancing patient outcomes.
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