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Immunovia, Inc. receives CLIA approval to begin testing of patients for pancreatic cancer with IMMray PanCan-d test

Immunovia AB
8 Aug 2021
Ellen Simms
Product and Reviews Editor

Industry news

Immunovia AB, a diagnostic company that develops highly accurate blood tests for the early detection of cancer and autoimmune diseases, has 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 in August, 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.

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Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.Blood AnalysisThe analysis of blood is vital for many areas of life sciences and forensic investigations. Blood samples can be tested for a number of different reasons such as diagnosis, glucose levels, cholesterol and drug testing.Cancer ResearchAlthough cancer is often referred to as a single condition, it actually consists of more than 100 different diseases. Microscopy, mass spectrometry, high throughput sequencing and flow cytometry are some of the most common techniques employed in cancer research labs.

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Immunovia, Inc. receives CLIA approval to begin testing of patients for pancreatic cancer with IMMray PanCan-d test