LUND, Sweden, April 22, 2021 /PRNewswire/ -- Immunovia
is launching its IMMray™ PanCan-d test in the US as a Laboratory
Developed Test (LDT) in Q2 2021. The company will explore a
positive Medicare coverage determination for the IMMray™ PanCan-d
test through the Local Coverage Determination (LCD)
process.
The IMMray™ PanCan-d test will be performed at Immunovia Dx
Laboratories in Marlborough,
Massachusetts, and will be available to all patients in the
US. In accordance with Medicare regulations, all Medicare billing
will be conducted by Immunovia Dx Laboratories through the Medicare
Administrative Contractor (MAC) that administers benefits in
Massachusetts (National Government
Services or NGS). Therefore, obtaining coverage from NGS would
be sufficient for coverage of all Medicare-participating patients
nationwide.
Patrik Dahlen, CEO Immunovia,
stated "We believe that the IMMray™ PanCan-d test, intended as an
aid in diagnosis in patients at high risk for developing pancreatic
ductal adenocarcinoma (PDAC), meets the reasonable and necessary
criteria for Medicare coverage."
Based on numerous interviews and working closely with experts on
the subject, Immunovia concludes that if the IMMray™ PanCan-d test
is used analogously to already-covered surveillance imaging
modalities, and for the same high-risk population, then it is
reasonable that both commercial payers and Medicare will view this
use of the test as a "diagnostic" test rather than a "screening"
test. Publications from the International Cancer of the Pancreas
Screening (CAPS) Consortium, NCCN, ASCO and US Preventive Services
Task Force (USPSTF) all recommend enrolling high-risk populations
for pancreatic cancer into surveillance programs. More
specifically, the high-risk population identified in the CAPS
guidelines as eligible for pancreatic cancer surveillance overlaps
almost completely with the population included in the
groundbreaking PanFAM-1 clinical utility study of the IMMray™
PanCan-d test.
Diagnostics reimbursement expert Dr. David Parker, a Senior Vice President at
Precision for Medicine, stated "Market research indicates that
surveillance imaging of patients at high risk for pancreatic cancer
is already routinely covered by payers, and is not considered as a
screening application of the imaging modalities. Immunovia will be
seeking coverage for the same surveillance use, in the same
population. It seems highly unlikely that payers will view the
IMMray™ PanCan-d test as a screening test, when they cover the
clinical alternatives as diagnostic."
Immunovia will continue to execute focused US studies –
including PanFAM-1 – to build the necessary evidence and dossiers,
and to thereby establish clinical utility. The company's aim is to
obtain coverage and reimbursement agreements with a majority of
U.S. payers prior to year-end 2022.
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, the IMMray™ PanCan-d test, 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
final validation study was completed in Q1 2021. Commercial testing
will begin in Q2 after the accreditation of Immunovia Dx
Laboratory in Marlborough,
Massachusetts, USA.
The IMMray™ PanCan-d test 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.
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