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Centers for Medicare & Medicaid Services finalizes its payment determination and sets a rate of $897 for Immunovia's IMMray PanCan-d test


News provided by

Immunovia AB

30 Nov, 2022, 08:09 GMT

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LUND, Sweden, Nov. 30, 2022 /PRNewswire/ -- Immunovia (Nasdaq Stockholm: IMMNOV) today announced that the Centers for Medicare and Medicaid Services (CMS) has finalized their payment determination on a price of $897 for Immunovia's IMMray PanCan-d test. The determined rate will be effective from 1st January 2023.

After a period of public comment CMS agreed with the recommendation made by the Clinical Diagnostic Laboratory Test (CDLT) Advisory Panel to crosswalk IMMray PanCan-d rate to code 81503, brand name OVA1, and set a price of $897 for Immunovia's test. 

"The CMS decision is a significant milestone in the commercialization efforts for our IMMray PanCan-d test and a further step on our path towards reimbursement. We are very pleased with CMS determination as it reinforces the value of the IMMray PanCan-d test. We continue to advance in our mission ensuring patients have access to early detection testing for pancreatic cancer in high-risk populations," said Philipp Mathieu, CEO and President of Immunovia. 

CMS is a federal agency within the United States Department of Health and Human Services that provides health coverage to more than 100 million people in the U.S. CMS sets the basis for payment for lab tests through the clinical lab free schedule (CLFS).  

More information on the billing and coding decision can be found on the CMS website under "Final Payment Determinations".  

For more information, please contact:
Philipp Mathieu,
CEO and President
philipp.mathieu@immunovia.com

Karin Almqvist Liwendahl
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com
+46 709 11 56 08

About Immunovia 
Immunovia AB is a diagnostic company with the vision to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.

Our first product, IMMray™ PanCan-d is the only blood test currently available for early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com.

Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups globally to make this test available to all high-risk pancreatic cancer groups. 

The USA, the first market in which IMMray™ PanCan-d is commercially available, is the world's largest market for the detection of pancreatic cancer with an estimated value of more than USD 4 billion annually.

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com. 

                                                                           ###

The following files are available for download:

https://mb.cision.com/Main/13121/3675195/1703988.pdf

Press release (PDF)

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