Immunovia has announced that the Commercial Test Model study was successful, showing a 95% accuracy, and the company is on track for commercialization of the IMMray PanCan-d commercial biomarker signature.
The signature, together with CA19-9, confirmed the same high accuracy from the optimization study done earlier this year, in differentiating early stages of PDAC versus patients with non-specific but concerning symptoms, including type II diabetics and healthy individuals.
“It is an amazing time for Immunovia. Achieving these fantastic results with IMMray PanCan-d commercial signature was the last major technical milestone before we start the final validation as planned and start sales in Q3 next year. An accurate and early blood test for pancreatic cancer is a revolutionary advancement in the way the world healthcare systems test for and detect this deadly disease and will make significant improvements in patient outcome and survival,” commented Mats Grahn. CEO, Immunovia.
About the Commercial Test Model Study
The study was performed in order to finalize the IMMray PanCan-d commercial biomarker signature and to validate its accuracy in differentiating PDAC (pancreatic ductal adenocarcinoma) stages I through IV vs. controls that best mirror the clinical, commercial setting situation i.e patients with non-specific but concerning symptoms, including type II diabetics as well as healthy individuals.
The study included a total of 1113 samples comprising 315 PDAC, 488 symptomatic controls and 310 healthy individuals. All these samples were freshly collected through our Key Opinion Leaders (KOL) at seven pancreatic diseases reference sites in USA and Europe. The sites contributing with samples in this study were: UCL Institute for Liver and Digestive Health, London UK; University of Pittsburgh, Division of Gastroenterology,Hepatology & Nutrition, Pittsburgh, USA; New York University Langone Health, Perlmutter Cancer Center, New York, USA; Beth Israel Deaconess Medical Center (BIDMC), Pancreas and Liver Institute, Boston, USA; Ramon y Cajal Institute for Health Research (IRYCIS), Madrid, Spain; Växjö Central Hospital, Department of Transfusion Medicine, Sweden, Hallands Hospital Varberg, Department of Transfusion Medicine, Sweden.
IMMray PanCan-d commercial signature in combination with CA 19-9 tumor marker was able to detect the PDAC samples of stage I through IV vs all controls with 96% accuracy. Additionally, the accuracy for detecting PDAC early stages I and II was 95% thus confirming that Immunovia’s IMMray PanCan-d combined with CA 19-9 enables accurate early detection of pancreatic cancer through a simple blood test.
The next steps
The next steps are Verification Study and Validation Study. The timelines to sales start remain on track for Q3 2020, reports the company.