IMMray™ PanCan-d

Immunovia reports historical breakthrough in early detection of pancreatic cancer in high risk groups

Immunovia reports positive results of the blinded clinical validation of IMMray™ PanCan-d blood test for Stage I/II pancreatic cancers in familial/hereditary risk groups in USA – and improved test performance in detecting early stage pancreatic cancer in high risk symptomatic patients

98%

Specificity

85%

Sensitivity

Immunovia reports positive results of the blinded clinical validation of IMMray™ PanCan-d blood test in USA

Stage I/II pancreatic cancers were detected with 98% specificity and 85% sensitivity in familial/hereditary risk group cohorts

Immunovia today announced the successful completion of the last development milestone of IMMray™ PanCan-d blood test designed for early detection of pancreatic cancer (PDAC). The blinded validation study data demonstrated that Immunovia’s IMMray™ PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls (reference PanFAM clinicaltrials.gov) and with a specificity/sentitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls. The blinded validation study, performed by Immunovia Dx Laboratory in Marlborough USA, analysed 591 samples including 167 PDACs whereof 56 PDAC stage I&II, 203 high risk individuals, and 221 healthy controls.

Classification performance IMMray™ PanCan-d biomarker signature and CA19-9

PDAC Stage I&II vs.
Familial/Hereditary controls

Specificity = 98%
Sensitivity = 85%
ROC AUC = 0.92

PDAC Stage I-IV vs.
Familial/Hereditary controls

Specificity = 98%
Sensitivity = 87%
ROC AUC = 0.94

PDAC Stage I&II vs. Healthy controls
Specificity = 99%
Sensitivity = 85%
ROC AUC = 0.93

PDAC Stage I-IV vs. Healthy controls
Specificity = 99%
Sensitivity = 87%
ROC AUC = 0.95

Samples have been freshly collected from 11 sites in the US and Europe: 

92%

Specificity

80%

Sensitivity

Immunovia reports improved test performance of IMMray™ PanCan-d in detecting early stage pancreatic cancer in high risk symptomatic patients

Stage I/II pancreatic cancer was detected with a specificity of 92% and a sensitivity of 80% in a clinical study

LUND, SWEDEN ― Immunovia today announced improved performance of its blood based IMMray™ PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study. The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed.

Classification performance IMMray™ PanCan-d biomarker signature and CA19-9

PDAC Stage I&II vs. Symptomatic controls
Specificity = 92%
Sensitivity = 80%
ROC AUC = 0.89

PDAC Stage I-IV vs. Symptomatic controls
Specificity = 92%
Sensitivity = 81%
ROC AUC = 0.90

Samples have been freshly collected from 7 sites in the US and Europe:

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.