Swedish diagnostics and testing firm, Immunovia, has announced that its pancreatic cancer diagnostic test saw a specificity of 98% as part of a clinical trial examining the test's reaction to pancreatic ductal adenocarcinoma (PDAC).
Intended to iterate on the company’s previous IMMray PanCan-d test for the detection of pancreatic cancer, the newest generation of the test also saw a sensitivity of 75% in detecting early stage 1 and 2 cancers, with the company saying that the test was significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer.
Additionally, Immunovia has said that its new test opens pancreatic cancer testing to a new demographic of patients, with approximately 10% of patients tested for pancreatic cancer unable to produce CA19-9, making previous versions of the company’s pancreatic cancer test unusable. Now, Immunovia says that its latest version of its IMMray PanCan-d test is faster, works more broadly and is overall cheaper.
Jeff Borcherding, CEO, and president of Immunovia, said: “Pancreatic cancer is a brutal and lethal cancer. People at risk for pancreatic cancer need a simple, fast, and easy blood test to detect cancer early. We are very excited about the potential of our test to meet this need and increase survival rates for these patients.”
GlobalData’s Medical Device Intelligence Centre details how the market for oncology tests was valued at approximately $1.9bn in 2022, reaching $3.1bn by 2030 with a compound annual growth rate (CAGR) of 12.8% by 2030. The oncology diagnostics market is a busy market host to a number of notable and large firms in the space, including companies such as Roche and Freenome.
The model development study was designed to select the highest-performing biomarkers to be included in the new version of the Immunovia test. The study included 481 blood samples from across the US and Europe, of which 133 were samples from patients with stage 1 or 2 PDAC.
Immunovia will now move to a second phase of the model development study, in which test performance will be evaluated in a more selective cohort of patients at high risk for pancreatic cancer.
The company also announced that it will perform several analytical validation steps to verify the accuracy and reproducibility of the protein biomarker measurements, after which the company will conduct a large clinical validation study to confirm the performance of the next-generation test ahead of an intended 2025 launch.
