COMPANY:

Immunovia

"Immunovia...will present results from the recently completed model-development study of the company’s next-generation test at the 2024 annual meeting of the Collaborative Group of Americas—Inherited Gastrointestinal Cancers (CGA-IGC)...Immunovia is currently conducting a clinical validation study of its next-generation test, which is expects to complete in December 2024. The company plans to launch the test later in 2025."

"Immunovia...will present an update on its next-generation test at the annual meeting of the PRECEDE Consortium, a collaboration of 51 pancreatic centers worldwide conducting unprecedented research for the early detection of pancreatic cancer in individuals with increased risk for the disease. Immunovia will share results from studies of its next-generation test to detect stage 1 and 2 pancreatic cancer, including the discovery study, model-development study, and analytical validation. As reported in a 1 August 2024 press release, the test demonstrated superior performance, with sensitivity of 85% and specificity of 98%, in the model-development study of 623 patient samples. In addition to presenting data on its next-generation test, Immunovia leaders will meet with PRECEDE researchers to discuss current research collaborations and future studies."

"Immunovia...today announces that the company has acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer...The study seeks to confirm the sensitivity and specificity reported previously in the company’s model-development study of its new test. The trial will be a case-control study evaluating the accuracy of the next-generation test in differentiating blood samples from people with early-stage pancreatic cancer from individuals without it."

"Immunovia...announces that the company has completed the analytical validation of its next-generation test designed to detect early-stage pancreatic cancer. The validation demonstrated excellent results across a comprehensive set of parameters, reinforcing the reliability and robustness of the test."

"Immunovia...presented detailed model-development study results at the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer (abstract #B027)...Immunovia shared results from the model development study of its next-generation test to detect stage 1 and 2 pancreatic cancer. The company disclosed its method for selecting the biomarkers that comprise the test, the construction of the test algorithm, and the test’s performance and stability."

"Immunovia...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 will assess the use of biomarker tests to detect pancreatic cystic neoplasms (PCNs, or pancreatic cysts) that develop into pancreatic cancer...The first study should be completed in 2025; the other two will last approximately five years."

"Immunovia...announces enhanced performance for its next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC) in high-risk individuals, which are potentially curable with surgery and modern treatments."

"Immunovia...today announces the company has filed a US provisional patent application to protect the intellectual property embodied in its next-generation test to detect stage 1 and 2 pancreatic cancer....Immunovia filed the provisional patent application with the Patent and Trademark Office (PTO) in the United States of America, the first market for commercializing the company's new test. In coming months, the company expects to submit additional clinical data to the USPTO bolster the patent application....Immunovia will conduct a large, independent clinical validation study in fourth quarter 2024 to confirm the accuracy of the Immunovia test. The company is on track to launch the new test in the US in 2025."

"Immunovia...presented detailed discovery study results for the company’s next-generation early detection test for pancreatic cancer at the PancreasFest 2024 Annual Meeting (abstract #P33)."

"Immunovia...today announces its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. In the study, Immunovia's next-generation test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer....In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the performance of the next-generation test, setting the stage for a U.S. launch in 2025."

"Immunovia...announces...that the company has successfully developed accurate and precise assays to measure targeted proteins for its next-generation test."

"Immunovia...announced the successful completion of the discovery phase for the Company’s next-generation test...The discovery study, which marks a key milestone in the development of Immunovia’s next-generation test to detect early-stage pancreatic cancer, successfully found more than a dozen proteins circulating in the blood that identified pancreatic ductal adenocarcinoma (PDAC) stage I and stage II patients."