Immunovia’s first to market product IMMray™ PanCan-d, is a long-sought solution for the unmet need of early and accurate detection of pancreatic cancer (PDAC).
The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world’s largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1. The final validation study was completed in Q1 2021. The accreditation process for Immunovia Inc. in Marlborough, Massachusetts, USA is ongoing and commercial testing will begin in Q2 after the accreditation. The European launch plan will be communicated Q2 2021.
IMMray™ PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome. The test will be exclusively provided by Immunovia Inc., Marlborough, Massachusetts, USA.
There are more than 7 million eligible patients annually and no existing accurate diagnostics option on the market. Immunovia targets a long-term market penetration of 30% after reimbursement and widespread coverage. The current size of the addressable market for IMMray™ PanCan-d is estimated to exceed USD 4 billion in EU and United States, across the three risk groups that the company targets: Hereditary/Familial, Early Symptoms and Newly Onset Diabetes after 50 years of age.
Immunovia’s financial targets set forth above constitute forward-looking information and are based on a number of assumptions about the environment in which the Company operates, which may vary significantly and deteriorate over time from what Immunovia assessed when the financial targets were adopted. As a consequence, Immunovia’s ability to achieve the financial targets consists of uncertainties and contingencies, some of which are outside the Company’s control. There is no guarantee that Immunovia can achieve the financial targets or that Immunovia’s financial position or operating profit will not differ materially from the financial targets.