Swedish diagnostic firm Immunovia has received approval from the Massachusetts Department of Public Health to begin testing patients for pancreatic cancer with the IMMray PanCan-d Test.
A laboratory-developed test (LDT), IMMray PanCan-d is claimed to be the first blood test which is dedicated to early detection of pancreatic cancer.
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The blood test is developed using the IMMray technology platform, which has the potential to detect complex diseases earlier and with higher accuracy.
IMMray PanCan-d is the first product to be developed using this technology.
This blood test can recognise biomarker signatures, or signs of the disease in the blood and helps to significantly increase the patients’ survival by detecting pancreatic cancer earlier, when surgical resection is possible.
The company has also received its CLIA Certificate of Registration for IMMray PanCan-d on 21 June 2021.
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By GlobalDataThis approval will allow Immunovia to immediately start selling the test in the US exclusively through its laboratory in Marlborough, Massachusetts.
Immunovia medical director Thomas King said: “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.”
The company stated that the test is undergoing clinical evaluation in some of the world’s largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1.
Immunovia CEO Patrik Dahlen said: “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.”
