LUND, Sweden, Nov. 2, 2020 /PRNewswire/ -- Immunovia, a
diagnostic company that develops highly accurate blood tests for
the early detection of cancer and autoimmune diseases, today
announced further details regarding the outcomes of the
Verification Study.
As previously communicated, the Verification study is the step
in the development process where samples are run on the final
commercial product with the locked biomarker signature that was
derived from the previous Commercial Test Model Study. The
Verification Study included samples collected from six sites in
Europe and three sites in the US,
which mirrors the clinical and commercial setting. In total 519
samples were analyzed, including 81 PDAC Stage I/II and 114 PDAC
Stage III/IV, 212 healthy and 112 symptomatic controls.
As announced last week, the results showed accuracy of 94% in
differentiating early stage I/II PDAC patients from healthy
controls. We now report a specificity of 99% and a sensitivity
of 78% for this comparison, yielding a high NPV of 0.993, which
minimize the number of false positive. Early stages I/II PDAC were
differentiated from all the controls with an accuracy of 91%,
with a now reported specificity of 93% and a sensitivity of 78%,
yielding an NPV of 0.993. The analysis was performed with the
locked commercial signature, without any re-training procedure, to
again mirror the commercial setting.
All samples fulfilled the inclusion criteria and no samples were
replaced after the test had been completed, ensuring that no
confounding factors affected the outcome. The results of the
Verification Study pave the way for the final Validation Study,
with a reported sales start at the end of Q1 2021 with subsequent
commercial testing in Q2.
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 19:50 CET on
November 2, 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 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.
CONTACT:
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SOURCE Immunovia AB