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Immunovia’s PanFAM-1 Prospective Study Gathers Over 3000 Familial Hereditary Pancreatic Cancer Risk Samples And Will Be Analysed In The Second Half Of 2021

February 15, 2021

LUND, SWEDEN ― According to the American Cancer Society, as many as 10% of pancreatic cancers are caused by familial and hereditary risk factors. PanFAM-1 is the largest prospective study to date, focusing on early diagnosis in high-risk individuals with Familial/Hereditary Pancreatic Cancer (FPC). Designed to support the road to reimbursement for Immunovia’s blood test, IMMray™ PanCan-d, the study has ended enrollment of new subjects October 30, 2020 from the 23 familial/hereditary pancreatic cancer high-risk surveillance programs in USA and Europe. The study reports the collection of over 3000 blood samples from 1265 subjects. The last blood samples will be collected in April 2021. All blood samples will be analysed in the second half of 2021.

IMMray™ PanCan-d is a complementary method to the two most commonly used testing methods today – Endoscopic ultrasound (EUS) and Magnetic Resonance Imaging (MRI), thus opening the way for novel and more accurate surveillance programs. The main goals of PanFAM-1 are:

  • to diagnose pancreatic cancer early
  • to provide clinical performance data with IMMray™ PanCan-d from a prospective cohort of high-risk asymptomatic individuals compared with currently used surveillance methods i.e. imaging technologies.

“We are excited to announce that we currently collected more than 3000 blood samples of high-risk familial hereditary individuals in the PanFAM-1 prospective study. We are aiming to make a significant impact on patients’ lives and to improve their chances of survival and therefore we need to detect cancer early when it is most treatable. We are looking forward to the results of the IMMray™ PanCan-d analysis of the PanFAM-1 cohort in the second half of this year”, says Patrik Dahlen, Immunovia CEO.

PanFAM-1 was designed in close collaboration with Key Opinion Leaders in pancreatic cancer driving familial risk programs in US and Europe. PanFAM-1 is a multicenter prospective study for early detection of pancreatic cancer in individuals presenting hereditary/familial risk factors. Important milestones of the study include the last subject enrolled on October 30, 2020, last blood samples collected on end of April 2021, and analysis with the validated IMMray™ PanCan-d in the second half of 2021.

There are 23 participating partners in PanFAM-1:
United States
: New York University Hospital, NY; Columbia University, NY; Mount Sinai Hospital, NY; Stanford Gastroenterology and Hepatology, CA; Yale University, CT; University of Chicago Medical Center, IL; Massachusetts General Hospital, MA; University of Massachusetts, MA; The Ohio State University, OH; Oregon Health & Science University, OR; University of Pennsylvania, PA; University of Pittsburgh Medical Center, PA and University of Utah, UT. Canada: The Research Institute of the McGill University Health Centre. Sweden: Karolinska University Hospital; Sahlgrenska University Hospital; Umeå University Hospital and Linköping University Hospital. Spain: University Hospital Ramon y Cajal; University Hospital Santiago de Compostela and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL). United Kingdom: University College London Hospital and The University of Liverpool.

 

For more information, please contact:
Patrik Dahlen, CEO, Immunovia
Email:
patrik.dahlen@immunovia.com
Tel: +46 73 376 76 64

 

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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Press release (PDF)