TEST:

IMMray™ PanCan-d

A novel multi-analyte blood test utilizing newly-discovered PDAC biomarkers has the potential to improve early detection of PDAC in high-risk individuals.

"Immunovia...today announces its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. In the study, Immunovia's next-generation test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer....In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the performance of the next-generation test, setting the stage for a U.S. launch in 2025."

In clinical practice, IMMray PanCan-d has a robust NPV; however, PPV is dramatically influenced by whether borderline results are characterized as a positive or negative result.

"Immunovia...announced plans to restructure its operations. The company will cease commercialization of its IMMray PanCan-d test in the United States to focus its resources on the further development and clinical testing of the Company’s promising next generation pancreatic cancer detection test...Immunovia expects to release further details about the next-generation test later this year, with an anticipated launch date in 2024."

"Immunovia...announced it will host an event to discuss the adoption of IMMrayTM PanCan-d test key opinion leaders on May 3, 2023, at 16:00 pm CET (10:00 am ET)...Immunovia Management will also discuss its commercialization strategy for IMMrayTM PanCan-d test in the U.S."

The clinical implementation of IMMray PanCan-d in asymptomatic high-risk surveillance populations showed results similar to those obtained in test validation, but a higher percentage of positive test results was obtained due to test utilization in the work-up of suspicious mass lesions of the pancreas.

"Immunovia...announced it is realigning its Swedish operations with its strategic priorities to drive R&D productivity and focus on the US commercialization of the IMMray™ PanCan-d test....Immunovia has initiated a consultation process with relevant Swedish unions to create the best possible transition for the affected employees. The Company will provide an update once the consultation process is concluded."

"Immunovia...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."

One-third of subjects that participated in the study have presumptive IPMNs. IMMray PanCan-d test classification (positive vs negative) is not significantly impacted by IPMN size although more subtle changes in decision values can be detected as a function of cyst size. These differences appear to result from differences in the contribution of the 8-protein biomarkers in samples for cysts >3.0 cm.

"Immunovia AB...announced that it enters into a strategic partnership with Proteomedix to leverage its substantial joint development experience in diagnostic technologies for the detection of cancer. This will enable increased R&D productivity for Immunovia as the Company continues to strengthen its commercial development in the US...The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have both launched innovative oncology tests, Immunovia with IMMray™ PanCan-d in the U.S. and Proteomedix with Proclarix® in Europe."

"Immunovia AB...announced positive feedback from its physician experience program for the IMMray™ PanCan-d test in the U.S., which is nearing completion. The program has included 23 high risk surveillance centers around the U.S. thus far, and physicians have showed substantial interest in the use of IMMray™ PanCan-d to detect early-stage pancreatic cancer."

"Immunovia AB...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 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."