LUND, Sweden, April 21, 2021 /PRNewswire/ -- Immunovia today
announced an updated assessment of the total market size for
familial/hereditary pancreatic cancer risk group in the US. New
estimations show that 315,000 – 350,000 individuals have a
familial/hereditary risk for pancreatic cancer and would qualify to
be enrolled in pancreatic cancer surveillance programs.
Immunovia's bloodtest IMMray™ PanCan-d for early detection of
pancreatic cancer is to be used for surveillance testing of high
risk individuals. The recent blided validation study showed that
IMMray™ PanCan-d and the tumor marker CA 19-9 detect stage I &
II pancreatic cancer with 85% sensitivity and 98% specificity in
familial/hereditary pancreatic cancer risk group.
Updated guidelines from US Preventive Services Task Force
(USPSTF), National Comprehensive Cancer Network (NCCN), American
Society of Clinical Oncology (ASCO), and the International Cancer
of the Pancreas Screening (CAPS) Consortium all conclude that the
general population should not be screened for pancreatic cancer.
Instead, it is recommended to follow-up on individuals with a
family history of pancreatic cancer, individuals with one first
degree relative (FDR) with a confirmed germline mutation that poses
an increased risk for pancreatic cancer and enrolling high-risk
individuals for pancreatic cancer into surveillance programs.
The updates of the guidelines has led the company to re-examine
the potential market size for surveillance of high-risk individuals
in the familial/hereditary risk group.
There will be approximately 60,000 new pancreatic cancer cases
this year in the US. Based on public and published data, 10% of all
new pancreatic cancer cases are attributed to a familial or
hereditary link. Given the number of historically documented cases
per year, and the fact that the average US family has two children
and a surveillance window of 30 years (surveillance programs enroll
persons at 50 – 80 years of age), the estimation concludes that
315,000 – 350,000 individuals have a familial/hereditary risk for
pancreatic cancer. Consequently, these individuals would qualify to
be enrolled in a pancreatic cancer surveillance program, using the
IMMray™ PanCan-d test.
Furthermore, recent data demonstrates that individuals with 1
First Degree Relative (FDR) have a 9-fold risk for developing
pancreatic cancer. The addition of these individuals in
surveillance program would increase the enrollment to over 3
million high risk individuals. This suggestion is not yet in any
guidelines. However, NCCN and ASCO already propose systematic
germline testing for persons with 1 FDR.
"We anticipate that a cost-effective and non-invasive method
like the IMMray™ PanCan-d test will be a key component to enable a
dramatic increase in number of individuals enrolled in surveillance
programs. The maximum potential market size for Immunovia, in terms
of number of tests assuming twice a year surveillance, today range
from 630,000 – 700,000 tests annually, following current
recommendations and guidelines. In the future, these numbers could
potentially grow to over 6 million tests per year – provided that
the new suggestions are converted to guidelines," said Patrik Dahlen, CEO Immunovia.
For more information, please contact:
Patrik Dahlen, CEO Immunovia
Tel: +46 73 376 76 64
This is information that Immunovia is obliged to make public
pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person
set out above, at 22:10 CET on April
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. The final
validation study was completed in Q1 2021. Commercial testing will
begin in Q2 after the accreditation of Immunovia Dx
Laboratory in Marlborough,
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
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
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