LUND, Sweden, Aug. 10, 2021 /PRNewswire/ -- Immunovia AB (publ)
("Immunovia"), announced last week that its US subsidiary,
Immunovia, Inc. in Marlborough,
MA, received final regulatory approval to begin patient
testing with the IMMrayTM PanCan-d test, the first and
only test on the market dedicated to the early detection of
pancreatic cancer. Today, Immunovia announces two updates on the
IMMRayTM PanCan-d test, regarding pricing and test
performance.
The IMMrayTM PanCan-d test is being launched at a
list price of 995 USD per test, which
is higher than the 600 USD per test
previously disclosed. The price has been adjusted to reflect recent
payer studies, which have shown strong price elasticity and health
economic benefits even at a higher price.
"We see a very strong interest for early detection of pancreatic
cancer among individuals with a family history, or individuals with
genetic predisposition for pancreatic cancer. We are proud to be
the first company that can provide a test for early detection of
pancreatic cancer, and we believe the test can make a significant
difference in the lives of high risk individuals in the
familial/hereditary high-risk group. A market that today in the US
comprises around 350,000 persons with the potential to grow to 1.5
million, if a national recommendation of testing hereditary
patients with one relative having pancreatic cancer is
implemented", said Patrik Dahlen,
Immunovia's CEO.
Moreover, Immunovia is launching the IMMrayTM
PanCan-d test for those individuals with CA19-9 levels greater than
2.5 U/ml. Since most individuals with very low CA19-9 are
genetically deficient in the Lewis antigen, which is required to
synthesize CA19-9, the IMMrayTM PanCan-d sensitivity is
lower in this population. With this modification, the overall
sensitivity of the IMMrayTM PanCan-d test improves to
89% in stages I and II and 92% in all stages. The specificity
remains at 99%.
"We are extremely pleased with the performance of the
IMMrayTM PanCan-d test, and we believe the test will be
well received by the key opinion leaders, and the market at large.
The test offers a performance well above our own expectations."
said Thomas King, MD, PhD, Medical
Director of Immunovia, Inc.
The IMMrayTM PanCan-d test is a laboratory developed
test (LDT) available exclusively at Immunovia, Inc.
Immunovia will report its H1 and Q2 results on the 19th of
August. CEO Patrik Dahlen, Medical
Director Dr. Thomas King and Sr.
Marketing Director US, Cindy
Callahan will present at the quarterly report audiocast on
the same day at 16:30 CEST, to
provide an update about the marketing plans following the launch of
the IMMRayTM PanCan-d test. The invitation to the
presentation of the quarterly report will be published shortly.
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
high risk groups in pancreatic cancer, PanFAM-1, PanSYM-1 and
PanDIA-1.
In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts, USA. The IMMray™
PanCan-d test, the first blood-based test dedicated to the early
detection of pancreatic cancer on the market, is offered as a
laboratory developed test (LDT) exclusively through Immunovia, Inc.
For more information see: www.immunoviainc.com. The European launch
plan will be communicated during the second half of 2021.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/immunovia-ab/r/immunovia-provides-updates-on-the-price-for-the-immray-tm--pancan-d-test-in-the-us-and-improved-test,c3394309
The following files are available for download:
https://mb.cision.com/Main/13121/3394309/1452301.pdf
|
Press relese
(PDF)
|