LUND, SWEDEN – Immunovia AB (Nasdaq Stockholm: IMMNOV) announced, that the Centers for Medicare & Medicaid Services (CMS) published a preliminary payment determination implying a price of $897 for the IMMray PanCan-d test. 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).
CMS agreed with the recommendation made by the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel to crosswalk IMMray PanCan-d rate to code 81503, brand name OVA1, which currently has a price of $897. After a period of public comment, CMS will finalize its basis for payment decision in November.
“Receiving the preliminary payment determination is an additional milestone on the previously communicated path for commercialization in the US. We are very pleased that the rate preliminarily determined by CMS appropriately values our innovative blood-based test for pancreatic cancer. While this does not represent a coverage determination to reimburse the IMMray PanCan-d test, it is an important step in the process of securing reimbursement for the IMMray PanCan-d test in the early detection of pancreatic cancer,” said Philipp Mathieu, CEO and President of Immunovia.
For more information, please contact:
CEO and President
Karin Almqvist Liwendahl
Chief Financial Officer
The information in this report is information that Immunovia AB 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 08:50 am CET on September 26, 2022.
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 https://immunovia.com/
Press release (PDF)