Health Diagnostics

Diagnostics Company Immunovia Receives Approval to Begin Testing

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

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.

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