LUND, SWEDEN, March 4, 2019 /PRNewswire/ -- Immunovia AB (publ)
("Immunovia") today announced an update on the optimization process
to refine the algorithms and eliminate any potential variations for
its commercial version of IMMray™ PanCan-d designed for early
detection of pancreatic cancer.
"The need for further optimization work was previously announced
in August 2018 (link to PR) and
during the past six months, we have been working diligently on the
optimization of the algorithm. As was indicated by the tests that
were performed, using as fresh samples as possible increases the
test performance. Through our large and growing network of
influential key opinion leaders, we were able to secure the
relevant samples needed to complete the optimization work,"
commented Mats Grahn, CEO,
Immunovia. Mr. Grahn continued, "It is imperative to note that we
need samples that best mirror the blood samples that will be used
with our final product. Like any diagnostics development company,
finding these fresh samples and gaining access to them is quite
difficult and takes time. Thanks to our experienced KOLs, we now
have these at hand to complete the optimization work. Going
forward, the verification and validation process of
IMMray™ PanCan-d will be conducted solely with samples
collected that best conforms to real-life, commercial
conditions."
As Immunovia previously announced in August 2018, the combination of retrospective
samples from different biobanks, with varying sample collection
procedures and storage time, introduced unforeseen variability
in the test algorithm performance. The distorting effect caused by
the variability in blood sampling procedures was eliminated by
consistent and optimal protocols. It is now concluded that for
optimal performance of the test, the samples should be collected
within 24 months to avoid potential storage distortions. The
steps to acquire these freshly collected samples for
the optimization work has pushed out the previously
communicated timeline to complete the optimization
work by about 8 weeks, which will impact the commencement of
sales accordingly. Acquiring the sample collection is a
significant improvement for the optimization process and is deemed
as an important and positive step towards commercialization.
The steps to market remain the same. The completion of the
optimization work will then trigger the commercial test model
study, followed by Verification and Validation studies.
Details on timing of these milestones will be communicated at
the end of April 2019.
"We remain confident that the steps taken to obtain blood
samples that best match the samples that will eventually be used by
clinicians in the diagnosis process is the key element for the
final adjustments before our commercial launch," concluded
Mats Grahn, CEO.
A telephone conference is scheduled on March 4, 2019, 10.30 CET to answer questions and
provide additional details.
Participant dial in numbers:
BE: +3226200548
DK: +4578150109
FR: +33170750775
DE: +4969222220380
NO: +4723500236
SE: +46856642705
CH: +41225805976
NE: +31207219496
UK: +443333009261
On the Immunova website under Investors/Audio Gallery
(https://immunovia.com/investors/audio-gallery/) there will be an
MP3 file for those who want to listen to the conference call later,
the file is available within two hours of the end of the conference
call.
For more information, please
contact:
Julie
Silber
Director of Investor
Relations
Email:
julie.silber@immunovia.com
Tel: +46-7-93-486-277
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 8.00 CET on March 4,
2019.
About Immunovia
Immunovia AB was founded in 2007 by investigators from the
Department of Immunotechnology at Lund University and CREATE Health, the Center
for Translational Cancer Research in Lund, Sweden. Immunovia's strategy is to
decipher the wealth of information in blood and translate it into
clinically useful tools to diagnose complex diseases such as
cancer, earlier and more accurately than previously possible.
Immunovia´s core technology platform, IMMray™, is based on antibody
biomarker microarray analysis. The company is now performing
clinical validation studies for the commercialization of IMMray™
PanCan-d that could be the first blood-based test for early
diagnosis of pancreatic cancer. In the beginning of 2016, the
company started a program focused on autoimmune diseases diagnosis,
prognosis and therapy monitoring.
(Source: www.immunovia.com)
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
About Pancreatic Cancer
Pancreatic Cancer is one of the most deadly and difficult to
detect cancers, as the signs and symptoms are diffuse and similar
to other diseases. There are more than 40,000 deaths and over
50,000 new cases diagnosed each year in the U.S. alone, and the
five-year survival rate for pancreatic cancer is currently 5-8 %.
It is predicted to become the second leading cause of cancer death
by 2020. However, because resection is more successful in stage
I/II, early diagnosis can significantly improve pancreatic cancer
patients' 5-year survival rates from 5-8 % to up to 49%.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/immunovia-ab/r/immunovia-provides-an-update-on-the-optimization-work-to-meet-the-expected-performance-for-commercia,c2755440
The following files are available for download:
https://mb.cision.com/Main/13121/2755440/1001358.pdf
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SOURCE Immunovia AB