LUND, Sweden, June 30, 2021 /PRNewswire/ -- Immunovia AB
(publ) ("Immunovia"), a diagnostic company that develops highly
accurate blood tests for the early detection of cancer and
autoimmune diseases, today announced that its American subsidiary
Immunovia, Inc. has received CLIA Certificate of Registration
Number 22D2227265.
The Certificate of Registration is a critical step in the
accreditation process of Immunovia, Inc.'s laboratory outside
Boston. The Certificate of
Registration is required by federal law and is a prerequisite to
receiving a clinical laboratory licensure from Massachusetts
Department of Public Health, which has the ability under CLIA to
approve laboratories.
Clinical laboratory licensure is required before Immunovia can
begin testing patients with the IMMrayTM PanCan-d test.
Immunovia is awaiting approval of the clinical laboratory license
application which was filed with the Massachusetts Department of
Public Health Clinical Laboratory Program in April. When approved,
the IMMray™ PanCan-d test will be the first blood test on
the market dedicated to the early detection of pancreatic cancer,
which will be exclusively provided from Immunovia,
Inc., Marlborough, Massachusetts,
USA.
"We are of course disappointed that the license process has been
much slower than normal due to a high workload at Massachusetts
Department of Public Health, as a result of the pandemic. This kind
of delays are out of our control and has also impacted our planned
announcement of the European launch plan. We now look forward to
obtain the final clinical laboratory licensure and the sales force
is ready to launch," said Patrik
Dahlen, CEO of Immunovia.
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. The final
validation study was completed in Q1 2021. The accreditation
process for Immunovia, Inc. in Marlborough, Massachusetts, USA is ongoing and commercial
testing will begin after the accreditation.
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. The test will
be exclusively provided from Immunovia, Inc., Marlborough, Massachusetts,
USA.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
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