On March 30, 2021 Immunovia reported improved performance of its blood based IMMray PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study (Press release, Immunovia, MAR 30, 2021, View Source [SID1234577294]). The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

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Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.