Immunovia AB received final regulatory approval to begin patient testing with the IMMray TM PanCan-d test, the first and only test on the market dedicated to the early detection of pancreatic cancer.
| LUND, Sweden, Aug. 10, 2021 /PRNewswire/ -- Immunovia (publ) (“Immunovia”), announced last week that its US subsidiary, Immunovia, Inc. in Marlborough, MA, received final regulatory approval to begin patient testing with the IMMrayTM PanCan-d test, the first and only test on the market dedicated to the early detection of pancreatic cancer. Today, Immunovia announces two updates on the IMMRayTM PanCan-d test, regarding pricing and test performance. The IMMrayTM PanCan-d test is being launched at a list price of 995 USD per test, which is higher than the 600 USD per test previously disclosed. The price has been adjusted to reflect recent payer studies, which have shown strong price elasticity and health economic benefits even at a higher price. “We see a very strong interest for early detection of pancreatic cancer among individuals with a family history, or individuals with genetic predisposition for pancreatic cancer. We are proud to be the first company that can provide a test for early detection of pancreatic cancer, and we believe the test can make a significant difference in the lives of high risk individuals in the familial/hereditary high-risk group. A market that today in the US comprises around 350,000 persons with the potential to grow to 1.5 million, if a national recommendation of testing hereditary patients with one relative having pancreatic cancer is implemented”, said Patrik Dahlen, Immunovia’s CEO. Moreover, Immunovia is launching the IMMrayTM PanCan-d test for those individuals with CA19-9 levels greater than 2.5 U/ml. Since most individuals with very low CA19-9 are genetically deficient in the Lewis antigen, which is required to synthesize CA19-9, the IMMrayTM PanCan-d sensitivity is lower in this population. With this modification, the overall sensitivity of the IMMrayTM PanCan-d test improves to 89% in stages I and II and 92% in all stages. The specificity remains at 99%. “We are extremely pleased with the performance of the IMMrayTM PanCan-d test, and we believe the test will be well received by the key opinion leaders, and the market at large. The test offers a performance well above our own expectations.” said Thomas King, MD, PhD, Medical Director of Immunovia, Inc. The IMMrayTM PanCan-d test is a laboratory developed test (LDT) available exclusively at Immunovia, Inc. Immunovia will report its H1 and Q2 results on the 19th of August. CEO Patrik Dahlen, Medical Director Dr. Thomas King and Sr. Marketing Director US, Cindy Callahan will present at the quarterly report audiocast on the same day at 16:30 CEST, to provide an update about the marketing plans following the launch of the IMMRayTM PanCan-d test. The invitation to the presentation of the quarterly report will be published shortly. For more information, please contact:
Patrik Dahlen, CEO Immunovia
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 http://news.cision.com The following files are available for download:
SOURCE Immunovia AB | ||||
Company Codes: Bloomberg:IMMNOV@SS, ISIN:SE0006091997, RICS:IMMNOV.ST, Stockholm:IMMNOV |
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