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Clinical performance

IMMray™ PanCan-d – peer-reviewed, blinded validation study published in Clinical and Translational Gastroenterology (2022)

Specificity and sensitivity for early stage PDAC detection increases to 99% and 89% when CA19-9 Lewis null individuals are excluded.

Detection of Early-Stage Pancreatic Ductal Adenocarcinoma from blood samples: Results of a multiplex biomarker signature validation study in Clinical and Translational Gastroenterology, February 14, 2022

Authors: Brand, Randall E. MD; Persson, Jan MD; Bratlie, Svein Olav MD; Chung, Daniel C. MD; Katona, Bryson W.; Carrato, Alfredo MD, PhD; Castillo, Marién PhD; Earl, Julie PhD; Kokkola, Arto MD; Lucas, Aimee L. MD; Moser, A. James; DeCicco, Corinne BS; Mellby, Linda Dexlin PhD; King, Thomas C. MD, PhD.

Link to the article

Commercial availability (2021)

IMMray™ PanCan-d is available as a laboratory developed test exclusively from Immunovia, Inc., USA.

For more information visit: www.immunoviainc.com.

Blinded clinical validation study (2021)

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 performed by Immunovia, Inc., Marlborough, USA.

Authors: Thomas King, Arash Zandian, Payam Delfani, Veronika Sjöberg, Randall Brand, Arto Kokkola, A. James Moser, Genesis Perez-Melara, Corinne DeCicco, Alfredo Carrato, María E. Castillo-Sánchez, Julie Earl, Aimee L. Lucas, Jan Persson, Daniel Chung, Madeline Friedman, Ava Siegel, Bryson W. Katona, Bárbara Luna-Sánchez, Irene Patricia Amil-Casas, Linda Dexlin Mellby.

Link to Webcasted telephone conference: Immunovia reports historical breakthrough in early detection of pancreatic cancer in high risk groups, March 30, 2021

 

Poster (2021.04): IMMray® PanCan-d Blinded Validation Study

Improved IMMray™ based test performance in detecting early stage pancreatic cancer in high risk symptomatic patients (2021)

The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms and was performed by Immunovia in Lund, Sweden.

Link to Press Release March 29, 2021

Link to Webcasted telephone conference: Immunovia reports historical breakthrough in early detection of pancreatic cancer in high risk groups, March 30, 2021

 

Commercial Test Model Study (CTMS) (2019)

Study to select and lock the IMMray™ PanCan-d commercial biomarker signature and evaluate its performance in differentiating pancreatic ductal adenocarcinoma (PDAC), stage I-IV vs. controls, simulating a commercial test situation.

Authors: Payam Delfani, Anders Carlsson, Thomas King, Randall Brand, Alexander Ney, Stephen P Pereira, A. James Moser, Genesis Perez-Melara, Corinne DeCicco, Alfredo Carrato, María E. Castillo-Sánchez, Julie Earl, Linda Dexlin Mellby

 

Poster (2021.02): Commercial Test Model Study – A multicenter survey

Optimization study (2019)

Differentiating pancreatic cancer from individuals with concerning symptoms, including type II diabetes.

Authors: Payam Delfani, Anders Carlsson, Thomas King, Randall Brand, Alexander Ney, Stephen P Pereira, Linda Dexlin Mellby

 

Poster (2021.01): Optimization Study – Differentiating pancreatic cancer from individuals with concerning symptoms, including type II diabetes

Discovery studies

The prestigious Journal of Clinical Oncology (JCO) published in August 2018 the results of the major retrospective clinical validation study performed by Scandinavian and US researchers, showing that the IMMray™ PanCan-d serum biomarker microarray detects early pancreatic cancer with 96% accuracy.

Authors: Linda D. Mellby, Andreas P. Nyberg, Julia S. Johansen, Christer Wingren, Børge G. Nordestgaard, Stig E. Bojesen, Breeana L. Mitchell, Brett C. Sheppard, Rosalie C. Sears, and Carl A.K. Borrebaeck

Publication in JCO (2018.11): Mellby et al. Serum biomarker signature-based liquid biopsy for diagnosis of early-stage pancreatic cancer.

Flyer for download (Pdf).

 

 

Poster (PancreasFest 2019): Differentiating Pancreatic Ductal Adenocarcinoma (PDAC) from individuals with symptoms suggestive of PDAC, including type II diabetes, with ROC AUC values above 0.95