IMMray™ PanCan-d - peer-reviewed, blinded validation study now published in Clinical and Translational Gastroenterology
Peer-reviewed validation of study results demonstrating the IMMray™ PanCan-d blood test can detect PDAC with high specificity (99%) and sensitivity (92%), and a test specificity of 99% and sensitivity of 89% for PDAC stages I & II.
LUND, Sweden, Feb. 17, 2022 /PRNewswire/ -- Immunovia AB (publ) announces that the peer-reviewed, blinded study to independently validate the clinical performance of IMMray™ PanCan-d has been published in Clinical and Translational Gastroenterology. The article is available online on the journal's website. This publication expands on the findings announced on March 29, 2021, and they have now been validated in this peer-reviewed publication. The publication has been authored and reviewed by numerous Key Opinion Leaders in the US and Europe participating in the study.
This study aimed to validate the overall clinical performance of the IMMray™ PanCan-d test across all patient samples and additionally to better understand the test performance in Lewis null (le/le) individuals, who cannot express CA19-9. Sample collection took place at 11 clinical centers globally and the study was performed by Immunovia, Inc. in Marlborough, MA, USA. The results demonstrate that the IMMray™ PanCan-d blood test can detect pancreatic ductal adenocarcinoma (PDAC) with high specificity (99%) and high sensitivity (89%) in stage I/II when excluding individuals with low levels of CA19-9.
"We are very pleased with the data and that the blinded validation study in collaboration with top-tier clinicians has been accepted for publication in this prestigious journal. This moves us a step closer towards our goal of reimbursement in the US and pursues our mission to improve survival rates for one of the deadliest cancers. Following the publication of this peer-reviewed study, we believe that established surveillance centers and gastroenterologists will now also be in a position to expand the usage of our IMMray™ PanCan-d test and recommend it to their patients," says Philipp Mathieu, Acting CEO and President, Immunovia.
"I cannot thank our collaborators enough for their commitment to this project and their critical contributions to this publication. I am very pleased that our peer-reviewed validation study results are now publicly available," says Dr. Thomas King, Medical Director, Immunovia.
Title: Detection of Early-Stage Pancreatic Ductal Adenocarcinoma from Blood Samples: Results of a Multiplex Biomarker Signature Validation study
Journal: Clinical and Translational Gastroenterology https://journals.lww.com/ctg/Abstract/9900/Detection_of_Early_Stage_Pancreatic_Ductal.26.aspx
About the study: The IMMray™ PanCan-d Blinded Validation Study aimed to validate the clinical performance of the IMMray™ PanCan-d test in differentiating pancreatic ductal adenocarcinoma (PDAC) stages I-IV vs. familial/hereditary high-risk individuals and healthy controls. Sample collection took place at 11 clinical centers globally and the study was performed by Immunovia, Inc. in Marlborough, MA, USA, with sample identity being blinded to Laboratory Technologists and the Laboratory Director throughout the study.
For more information, please contact:
Philipp Mathieu
Acting CEO and President
Email: Philipp.mathieu@immunovia.com
Tobias Bülow
Senior Director Investor Relations and Corporate Communications
Email: tobias.bulow@immunovia.com
Tel: +46 736 36 35 74
The information was submitted for publication on February 17, 2022, at 08:00 a.m. CET.
About Immunovia
Immunovia AB is a diagnostic company with the vision to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.
Our first product, IMMray™ PanCan-d is the only blood test currently available specifically for the early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups globally to make this test available to all high-risk pancreatic cancer groups.
The USA, the first market in which IMMray™ PanCan-d is commercially available, is the world's largest market for the detection of pancreatic cancer with an estimated value of more than USD 4 billion annually.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
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