Immunovia is a diagnostics company with the vision to revolutionize blood-based diagnostics and increase the survival rate for patients with cancer. Immunovia has launched the first blood test in the world designed for the early detection of pancreatic cancer, a serious form of cancer with a low survival rate. The low survival rate is explained by the fact that pancreatic cancer is usually detected at a late stage when the tumor has metastasized.
Immunovia has developed IMMray® PanCan-d, which is the first blood-based test specifically developed for the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). Since 2016, Immunovia has conducted several large-scale studies targeting the main pancreatic cancer risk groups. Altogether, the studies have been conducted at around 30 hospitals in the USA and Europe and included several thousand patients. Based on the studies conducted, Immunovia’s assessment is that IMMray® PanCan-d has unmatched clinical performance for the early detection of pancreatic cancer.
- IMMray® PanCan-d is offered exclusively by Immunovia Inc. (Immunovia’s US subsidiary) as a laboratory-developed test (LDT). During 2022, Immunovia has significantly strengthened its US organization to drive market acceptance and has worked towards cost reimbursement in the US market, which the Company considers to be the largest and most lucrative market.
- Commercialization of IMMray® PanCan-d started in August 2021 in the United States. In 2022, Immunovia took decisive steps in the process towards reimbursement in the US. In June 2022, the Company received approval for a Current Procedural Terminology Proprietary Laboratory Analyzes (CPT PLA) code from the American Medical Association (AMA) for the IMMray® PanCan-d test. The code became effective on 1 October 2022.
- Another important step was taken in November 2022 when the Centers for Medicare & Medicaid Services (CMS) set the pricing at USD 897 for Immunovia’s IMMray® PanCan-d test. Payment for the IMMray® PanCan-d with this PLA code has been included in the CMS Clinical Lab Fee Schedule 2023 and established pricing became effective on 1 January 2023.
- The Company intends to make a series of investments over the next 24 months as part of scaling up operations and accelerating the commercial rollout of IMMray® PanCan-d. The investments include, among other things, expanding the sales organization and the Company’s network of leading Key Opinion Leaders as well as investing in digital marketing to drive demand and support continued sales growth.