New diagnostic test soon ready for the market

Pancreatic cancer is one of the most aggressive and difficult cancers to diagnose. When detected at an early stage, 5-year survival rates are greatly improved. Immunovia’s first diagnostic test, IMMray PanCan-d, is a unique blood test for the early detection of pancreatic cancer that has the potential to dramatically increase patient survival rates: from 5-8 percent to up to 49 percent.

Immunovia’s Medical Director Dr. Thomas King, MD, PhD, outlines the clinical utility of diagnostic tests in pancreatic cancer:

Familial risk group:

Regarding early detection of PDAC in the familial risk group, and based on the data available to date, do you foresee that IMMray PanCan-d would deliver clinical utility in a clinical setting?

– Yes, the currently available surveillance methods for individuals at high risk for PDAC are cumbersome, expensive and suboptimal. The sensitivity and specificity of noninvasive imaging tests is poor (40-60 percent specificity for CT and MRI) and while the results of invasive testing are somewhat more reliable, the cost and risk of these procedures is significant. IMMray PanCan-d can provide superior sensitivity and specificity without resorting to invasive testing in this population. For individuals at high genetic/familial risk, the availability of a blood test that can be performed for serial monitoring will be a huge advance. This is critically important since evidence has shown that individuals with PDAC detected during surveillance have significantly improved survival compared to individuals with PDAC not detected in surveillance programs (Canto et al. Gastro 2018).

Familial risk group:

What more would you require in terms of data and proofs to use this test in the familial/hereditary risk group clinical setting?

– Immunovia has initiated prospective clinical trials in all our targeted test indications. The results of our prospective studies are important to meet the high expectations of academic physicians for patients in the risk groups.  These trials have been planned and executed with great care and have now enrolled over 10,000 patients. Sample analysis will begin in 2021 in coordination of the clinical launch of IMMray PanCan-d. We are also planning small investigator-initiated studies in the US with our KOLs to address specific clinical questions they have and to give them experience with IMMray PanCan-d. 

NOD – New Onset Diabetes in patients over the age of 50 years:

Do you think there is a clinical unmet need in the area of Pancreatic Cancer diagnosis in older individuals with NOD?

– Type 2 diabetes is increasing in many world populations at a frightening rate and providing a noninvasive test to identify the subset of those individuals with PDAC will be even more important in the future.  Immunovia has initiated a prospective study (PanDIA) to identify individuals with NOD who will benefit from screening with IMMray PanCan-d.  This study will permit the development of screening tools (e.g. NOD associated with weight loss) to make such screening practicable and concordant with existing cancer screening guidelines.

Symptomatic patients in gastro centers:

Regarding early detection of PDAC in the symptomatic risk group, and based on the data available to date, do you foresee that this test would deliver clinical utility in a clinical setting? 

– Many individuals with nonspecific GI symptoms spend more than one year seeing a number of different doctors and undergoing various tests before a PDAC diagnosis is reached. This long time interval almost certainly decreases their survival and eliminates the possibility of a surgical cure. A positive IMMray PanCan-d test result early in their work up would greatly accelerate their diagnosis and access to appropriate therapy.  Conversely, since most individuals with vague symptoms do not have PDAC, a reliable negative IMMray PanCan-d result can obviate the need for invasive diagnostic studies and permit GI specialists to concentrate their effort on individuals who have actually have PDAC.

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 pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is currently in the final validation phase. The company aims for a sales start at the end of Q1 2021 with subsequent commercial testing in Q2.

When validated, IMMray PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome.

Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA, and Lund, Sweden, will provide laboratory testing services in two accredited reference laboratories.

Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

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