LUND, Sweden, Aug. 4, 2021 /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.
For more information, please contact:
Patrik Dahlen, CEO Immunovia
Email: patrik.dahlen@immunovia.com
Tel: +46 73 376 76 64
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 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.
This information was brought to you by Cision
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SOURCE Immunovia AB