(Información remitida por la empresa firmante)
We reported updates from our clinical programs, including results from our PanFAM-1 study and our PanDIA-1 study. The PanFAM-1 study was a prospective, multi center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. The IMMray™ PanCan-d test met its primary endpoint of test specificity comparable to imaging in the study. Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants. We also provided an update on the PanDIA-1 study which moved into its next phase using one of the largest, comprehensive prospective sample collections for early detection of pancreatic cancer in new onset type 2 diabetics to further develop and validate our test for this large risk group. In the current phase of being an early commercial company it is critical for Immunovia to focus internal resources on strengthening its commercial development in the US and accelerate the rollout of IMMray™ PanCan-d while maximizing R&D productivity. For this reason we launched a strategic partnership with Proteomedix, a Switzerland-based proteomics company and an expert in proteomics-based oncology diagnostics. This collaboration leverages the substantial joint development experience in diagnostic technologies for the detection of cancer and provides Immunovia with a more flexible and efficient R&D organization.
To summarize 2022, we sharpened our focus on pancreatic cancer and commercializing the IMMray™ PanCan-d test in the US market and I am very proud of what the Immunovia team has achieved, delivering on our strategic priorities by:
Substantially strengthening our US organization to enable rapid commercial growth
Receiving a Clinical Laboratory License in all US states but one
Receiving a CPT PLA code for our test
Receiving a final payment determination of $897 from Centers for Medicare & Medicaid Services, which appropriately values our innovative test
Launching a strategic R&D partnership with Proteomedix
All of the above are critical and very promising milestones in the US market development for our test paving the way for rapid, future growth.
Looking into 2023, I am very confident that the continued execution of our strategy will result in further increasing adoption of our test through heightened awareness and initial successes in obtaining reimbursement as well as a broadening of the clinical validation of our test for the current and additional risk groups within pancreatic cancer.
I want to thank our stakeholders for their continued support and look forward to a new year with further major milestones in improving pancreatic cancer survival rates.
February 23, 2023
Philipp Mathieu, CEO and President
Immunovia AB
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 70 911 56 08
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 08:30 am CET on February 23, 2023.
Conference call
Immunovia will hold a webcast tele conference at 11:00 pm CET on February 23 with President and CEO Philipp Mathieu and CFO Karin Almqwist Liwendahl.
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Sweden: +46 8 5051 0031
United Kingdom: +44 207 107 06 13
United States: +1 631 570 56 13
Link to the webcast: https://link.edgepilot.com/s/94d445d8/kGg7TnRc0kW8IMCMe-92zw?u=http://creo-live.creomediamanager.com/d1d6a3da-b961-48c9-beb8-3d4026f05d6f
About Immunovia
Immunovia 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, addressable market size of 1.8 million individuals per year who could benefit from our test.
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
The following files are available for download:
View original content:https://www.prnewswire.co.uk/news-releases/immunovia-publishes-full-year-report-for-2022-301754118.html