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Final Approval Received to Begin Patient Testing

August 4, 2021

Immunovia, Inc. Receives Final Approval to Begin Patient Testing with IMMray® PanCan-d Test

The first blood test dedicated to the early detection of pancreatic ductal adenocarcinoma in individuals at high-risk for familial or hereditary pancreatic cancer.

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Today, Immunovia, Inc., the American subsidiary of Immunovia AB (Nasdaq Stockholm: IMMNOV), announced that it has received final approval to begin patient testing for the IMMray® PanCan-d test – the first blood test on the market dedicated to the early detection of pancreatic cancer. This approval was received from the Massachusetts Department of Public Health on August 3, 2021. Immunovia, Inc. received its CLIA Certificate of Registration on June 21, 2021 (CLIA Number: 22D2227265).

“We are extremely pleased to have achieved this important milestone and to be able to launch the first non-invasive, highly accurate blood test that can help detect pancreatic cancer in early stages. The IMMray® PanCan-d test fulfills an unmet clinical need and our ambition is to make the test available to individuals in all the high-risk groups for pancreatic cancer. As a first step, we will launch the test for the familial/hereditary high-risk group,” said Patrik Dahlen, Immunovia’s CEO.

There will be approximately 60,000 new pancreatic cancer cases in the U.S. this year. Approximately 10-15% of all pancreatic cancer cases are attributed to a familial or hereditary link.

“The early diagnosis of pancreatic cancer is key to improving patient outcomes and survival rates. We’re encouraged by the results presented by Immunovia’s IMMray® PanCan-d blood test and the company’s progress toward an early detection strategy for this disease,” said Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network (PanCAN).

The IMMray® PanCan-d test is the first product developed from Immunovia’s proprietary immunoproteomics-based technology platform, IMMray®, that measures the immune system’s response to diseases in the blood. In a validation study presented in March, early stage (stages I and II) pancreatic ductal adenocarcinomas were detected with 99% specificity and 89% sensitivity in familial/hereditary risk group cohorts.

“As someone with family history of pancreatic cancer, I understand firsthand how important it is to have a test such as this available,” said Thomas King, MD, PhD, Medical Director of Immunovia, Inc. “With the Massachusetts State approval, we are excited to be able to offer the first commercial testing option for those individuals at high-risk for pancreatic cancer.”

The IMMray® PanCan-d test will be available exclusively from Immunovia, Inc., in Marlborough, MA and is intended only for individuals who are at high-risk for developing familial or hereditary pancreatic cancer.

To learn more about the IMMray® PanCan-d test and familial/hereditary risk factors for pancreatic cancer, please visit: www.immunoviainc.com

About Immunovia
Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia’s proprietary test platform called IMMray®. Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique “disease biomarker signature”.

The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immunotechnology at Lund University and CREATE Health Cancer Center, Sweden.

In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts, USA. The IMMray® PanCan-d test, the first blood-based test dedicated to the early detection of pancreatic cancer on the market, is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information visit: www.immunoviainc.com.

The IMMray® PanCan-d test is undergoing clinical evaluation in some of the world’s largest clinical studies for high risk groups in pancreatic cancer, including PanFAM-1, PanSYM-1 and PanDIA-1.

Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm.

For more information about Immunovia AB, please visit www.immunovia.com.

Contacts

Kirsten Lance
443-285-2706
klance@denterlein.com