Immunovia’s next-generation in vitro diagnostic (IVD) for early-stage pancreatic ductal adenocarcinoma (PDAC) has shown promising results in a clinical evaluation study.
The Swedish diagnostic company’s test demonstrated a sensitivity of 78% and a specificity of 94% in detecting Stage I and II PDAC, achieving a sensitivity and specificity of 80% and 91% respectively in patients aged 65 and above.
Judged against CA19-9, a US Food and Drug Administration (FDA)-approved biomarker for monitoring pancreatic cancer, the test was found to be 14 percentage points more sensitive while maintaining equivalent specificity.
Immunovia’s study used more than 1,000 patient samples from 18 leading cancer centres, with 202 coming from patients with stage I and II pancreatic cancer and the remaining 864 being control samples from individuals at high risk for pancreatic cancer.
According to the company, the study’s use of high-risk controls made it a more rigorous assessment of test accuracy, as opposed to most other validation studies that use blood samples from healthy, low-risk controls.
The study also observed that the test was equally accurate in detecting Stage I and II pancreatic cancers and that its performance, at a sensitivity of 82% and specificity of 95%, was higher in blood samples collected within the last five years. Immunovia said that due to the rarity of stage I and II pancreatic cancer samples, 56% of samples included in the study were older than five years, but noted that in real-world clinical use, samples would be tested within days of collection, suggesting the test would show even greater accuracy on average.
Immunovia’s CEO and president Jeff Borcherding said the evidence for the test’s accuracy marked a pivotal milestone in the company’s quest to transform the pancreatic cancer landscape.
Dr Rosalie Sears, professor of molecular and medical genetics at Oregon Health and Science University and an investigator on the study, commented: “This study validates the high accuracy of the Immunovia test in detecting stage I and II pancreatic cancer in a challenging high-risk population.
“The increase in accuracy for samples collected more recently is very encouraging, suggesting we could expect even better accuracy when the test is used clinically on fresh blood samples."
Immunovia said that based on the trial results of the test, for which it filed a patent in the US in August 2024, it is on track to introduce it into the US market in the second half of 2025. The company added that it plans to conduct additional clinical studies to assess the test’s accuracy, clinical impact, and economic value across different high-risk patient groups, with studies set to continue throughout 2025 in support of regulatory submissions and efforts to secure test reimbursement.
According to a report by GlobalData, as of May 2024, Immunovia had 11 devices at various stages of development in its product pipeline. GlobalData’s Market Size & Growth database indicates that the global IVD market for oncology was valued at around $1.48bn in 2023. Growing at a CAGR of 8.8%, it is forecast to reach a valuation of around $2.87bn by 2033.
