LUND, Sweden, March 30, 2021 /PRNewswire/ -- 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. These samples have
been freshly collected from 11 sites in the US and Europe: Mt Sinai School of Medicine, Beth
Israel Deaconess Medical Center, University of
Pittsburgh Medical Center, BioIVT, Discovery Life Sciences,
Inc., Massachusetts General Hospital, and University of Pennsylvania in the US; Sahlgrenska
University Hospital and Växjö Central Hospital in Sweden; Helsinki
University Hospital in Finland; and Ramón y Cajal University
Hospital, IRYCIS, CIBERONC in Spain.
MD, PhD, Thomas King, Medical
Director Immunovia Dx Laboratory, Marlborough, USA commented: "IMMray™ PanCan-d showing
specificities of 98% and 85% sensitivities for early stages of
pancreatic cancer versus a cohort of familial/hereditary risk group
are a historical breakthrough both for Immunovia and for improving
pancreatic cancer survival. We will be filing for the Massachusetts
State License and CLIA registration for Immunovia Dx Laboratory in
USA as soon as practically possible before commercialization starts
in USA".
Patrik Dahlen, CEO, Immunovia
added: "This is a historical moment for Immunovia and we have all
been working very hard since the very beginning with this one goal
in mind: to provide an accurate and early blood test for pancreatic
cancer. For the IMMray™ PanCan-d to now show 99% specificity for
early stage pancreatic cancer in a large blinded study is a truly
revolutionary advancement for healthcare systems in the way they
will test and detect this deadly disease, and will result in great
improvements for the patients and their families. It is simply
fantastic for us to now enter commercialization in the US."
Webcasted teleconference
These results will be presented Tuesday March 30, 2021, in
a webcasted teleconference at 16.30 (CET).
Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO,
Immunovia
The presentations will be followed by a Q&A session. The
webcasted teleconference will be held in English.
Dial-in details:
SE: +46 856642651
US: +18558570686
UK: +44 3333000804
Pin code: 20761152#
Webcast: https://financialhearings.com/event/13801
Following the teleconference, a recording will be available on
Immunovia's website (www.immunovia.com).
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 21:20 CET on
March 29, 2021.
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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SOURCE Immunovia AB