Lund /PRNewswire/ - Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, today announced that Immunovia, Inc. 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). As a result, Immunovia, Inc. can immediately begin selling the IMMray™ PanCan-d test for early detection of pancreatic cancer in the US exclusively through their laboratory in Marlborough, Massachusetts.
"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 meets a huge 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.
"With the Massachusetts State approval, we are excited to be the first to offer commercial testing for individuals at high risk for pancreatic cancer using the IMMray™ PanCan-d test," said Thomas King, MD, PhD, Medical Director of Immunovia, Inc.
The IMMray™ PanCan-d test is a laboratory developed test (LDT) that will be the first blood test on the market dedicated to the early detection of pancreatic cancer. By recognizing biomarker signatures, or signs of the disease in the blood, the IMMray™ PanCan-d test has the potential to significantly increase the survival of patients by detecting pancreatic cancer earlier, when surgical resection is possible.
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 Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden.
The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world's largest clinical studies for high risk groups in pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1.
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 see: www.immunoviainc.com. The European launch plan will be communicated during the second half of 2021.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
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