Additional Sample Collection for Validation Study Hindered
due to COVID-19 Infection Rate Increase, Causes Delay in Sales
Launch
LUND, Sweden, Oct. 26, 2020 /PRNewswire/ -- Immunovia, a
diagnostic company that develops highly accurate blood tests for
the early detection of cancer and autoimmune diseases, today
announced that the Verification study analysis confirms the
positive and technical performance of
IMMray™ PanCan-d, in line with previous results,
further substantiating the accuracy and robustness of the
IMMray™ platform technology.
The results showed excellent accuracy of 94% in differentiating
PDAC patients from healthy controls and 91% for differentiating
early stages I/II of PDAC versus all controls. The controls were
comprised of patients with non-specific but concerning symptoms,
including type II diabetics and healthy individuals.
The Verification study is the step in the development process
where samples are run on the final commercial product with the
locked biomarker signature finalized in the previous Commercial
Test Model Study. The verification study included samples collected
from many different sites, mirroring the commercial setting.
"While we are very pleased with the positive technical outcome
and the accuracy of the verification study, it was necessary to use
some samples that had originally been allocated to the Validation
process in order to increase the statistical significance of the
results," said Mats Grahn, CEO.
Furthermore, COVID-19 infections are once again on the rise
across the US, UK, Germany and
Spain. Patient flows at the sample
collection centers have significantly decreased in recent weeks.
This affects the previously agreed to sample collection rate and
the collection of the additional samples needed to complete the
Validation study in accordance with the previously communicated
timeline of Q4 2020. Based on the current impact of COVID-19
on sample collection, the company aims for a sales start at the end
of Q1 with subsequent commercial testing in Q2.
CEO, Mats Grahn, and incoming
CEO, Patrik Dahlen will host a
webcast to further discuss and hold a question and answer session
today. The live webcast is scheduled to begin at 4:30 p.m. CET on October
26, 2020.
Event Details:
To join the webinar: Register for Webinar (link)
About the Verification Study
The study was performed in order to verify the IMMray™ PanCan-d
commercial biomarker signature using known samples and to further
validate its accuracy in differentiating PDAC (pancreatic ductal
adenocarcinoma) stages I through IV vs. controls that best mirror
the clinical, commercial setting situation (i.e. healthy controls
and patients with non-specific but concerning symptoms). All the
samples were freshly collected through our Key Opinion Leaders
(KOL) at pancreatic diseases reference sites in USA and
Europe. The verification study
precedes the final blinded validation study required for sales
start.
About the Validation Study
The study is performed in order to verify the IMMray™ PanCan-d
commercial biomarker signature using blinded samples and to further
validate its accuracy in differentiating PDAC (pancreatic ductal
adenocarcinoma) stages I through IV vs. controls that best mirror
the clinical, commercial setting situation (i.e. healthy controls
and patients with non-specific but concerning symptoms). For the
sales start in Immunovia Dx Lab in Marlborough USA, a CLIA-CAP accreditation is necessary and
the blind validation study will contribute with data to this
accreditation. All the samples are being freshly collected through
our Key Opinion Leaders (KOL) at pancreatic diseases reference
sites in USA and Europe. Once
successfully completed, sales will begin, first to self-paying
customers.
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 16:00 CET on
October 26, 2020.
For more information, please contact:
Julie Silber, Director of
Investor Relations, Immunovia
Email: julie.silber@immunovia.com
Tel: +46 7 93 486 277
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 for sales start Q1 2021.
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.
CONTACT:
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