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Immunovia (IMMNOV: Nasdaq Stockholm) has completed the analytical validation of its next-generation test for early-stage pancreatic cancer detection. The validation demonstrated excellent results across 23 key performance attributes, meeting CLIA and CAP accreditation standards. Key highlights include high precision, linearity, sensitivity, stability, and robustness. The test uses an automated ELISA analyzer, enhancing performance and throughput compared to previous methods.
Following this success, Immunovia has initiated a large-scale clinical validation study to assess the test's accuracy in detecting stage 1 and 2 pancreatic cancer, expected to be completed by December 2024. This study will provide important insights into the test's clinical performance, including sensitivity and specificity.
Immunovia (IMMNOV: Nasdaq Stockholm) presented results from its model development study for a next-generation pancreatic cancer detection test at the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer. The study, involving 623 patient samples, demonstrated the test's superior performance with 85% sensitivity and 98% specificity. Notably, the test's sensitivity surpassed that of CA19-9, a common pancreatic cancer biomarker, by 20 percentage points.
The presentation detailed the biomarker selection process, algorithm construction, and test performance. Immunovia's VP of Clinical and Medical Affairs, Norma Palma PhD, emphasized the importance of scientific review and data dissemination for driving adoption of the test, which is slated for launch next year.
Immunovia (Nasdaq Stockholm: IMMNOV) has filed a US provisional patent application for its next-generation test to detect stage 1 and 2 pancreatic cancer. The application covers methods of diagnosing pancreatic ductal adenocarcinoma (PDAC) using a unique combination of five specific biomarkers. The company plans to submit additional clinical data to strengthen the application and file a PCT application within a year for international protection.
Immunovia aims to launch the new test in the US market in 2025, following a large, independent clinical validation study in Q4 2024. The company estimates that 1.8 million individuals in the USA are at high risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia (IMMNOV) has completed development of its next-generation pancreatic cancer detection test, achieving 85% sensitivity and 98% specificity in detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC). The test outperformed CA19-9, a common pancreatic cancer biomarker, by 20 percentage points. In patients aged 65 and older, the test achieved 91% sensitivity and 98% specificity. The study included 624 patient samples from 13 clinical sites. Immunovia plans to launch the test in the U.S. in 2025, following a large, independent clinical validation study in Q4 2024. The company estimates that 1.8 million high-risk individuals in the USA could benefit from annual surveillance testing.
Immunovia (Nasdaq Stockholm: IMMNOV) presented detailed discovery study results for its next-generation early detection test for pancreatic cancer at the PancreasFest 2024 Annual Meeting. The study, the most comprehensive pancreatic cancer proteomics study to date, identified 15 promising protein biomarkers that strongly correlate with pancreatic ductal adenocarcinoma (PDAC). Over 3,000 proteins were evaluated in 329 blood samples from Stage I and II PDAC and non-PDAC matched control patients using Olink multiplex technology and conventional immunoassays. The biomarkers demonstrated the ability to differentiate PDAC cases from non-PDAC controls. This presentation reflects the initial positive data shared in a November 7, 2023 press release.
Immunovia (NASDAQ: IMMNOV) has announced that its new lab in Research Triangle Park, USA, is now fully operational and staffed. The lab, focused on early detection of pancreatic cancer, was occupied on May 21, 2024, and all necessary equipment has been installed and validated. Two new scientists have been hired, and the team will validate assays developed with Proteomedix on an ELISA platform. The lab will conduct a clinical validation study of the next-generation test in Q4 2024. Immunovia has also filed to transfer its CLIA license and renew its CAP accreditation.
Immunovia, a diagnostics company focused on increasing pancreatic cancer survival through early detection, will move its lab and U.S. headquarters to Research Triangle Park in North Carolina in May 2024. This move follows successful model development and discovery phase completion. The company aims to confirm the analytical validity of its new test and conduct a large clinical validation study under the leadership of Dr. Lisa Ford. The move supports Immunovia's strategy to streamline operations and reduce costs, with Research Triangle Park providing access to top talent at a lower cost.
