The diagnostic company Immunovia (NASDAQ: IMMNOV) based in Stockholm recently announced its plan to restructure its business. The company intends to discontinue the commercialization of its IMMray PanCan-d test in the United States and redirect its focus and resources toward further developing and clinically testing next-generation pancreatic cancer detection tests. The upcoming next-generation detection method aims to be equally effective across a broader range of patient risk groups and provide accurate results for patients who do not produce CA19-9, reducing the dependence on CA19-9, which was a limitation of the IMMray PanCan-d test. This strategic decision is expected to offer greater commercial potential and contribute to the company’s continued growth. Immunovia plans to release more details about the next-generation test later this year, with a projected launch date set for 2024.
Immunovia’s decision to prioritize the next-generation assay will result in significant layoffs in various departments in Sweden and the United States. The company also aims to reduce other operating expenses to lower its cash burn rate and extend its cash reserves until 2024. It’s worth noting that in January 2022, Immunovia previously announced layoffs of its research and development staff in Sweden to better focus on promoting its ImmRay PanCan-d test in the United States. Additionally, although the sensitivity analysis of IMMray PanCan-d in the PanFAM-1 study conducted on June 27, 2022, was affected by uncertainties, the December 2022 report indicated the continued commercialization of the test in the United States.
Immunovia, founded in 2007, is a diagnostic company dedicated to developing and commercializing high-precision blood tests using its proprietary testing platform, IMMray®, for early detection of cancer and autoimmune diseases. The tests utilize antibody biomarker microarray analysis, advanced machine learning, and bioinformatics to select a panel of relevant biomarkers that indicate specific diseases, forming unique “disease biomarker signatures.”
One of Immunovia’s blood tests, PanCan-d, was developed for the early detection of pancreatic cancer. This test utilizes Immunovia’s immunoproteomics technology platform, IMMray®, to measure the immune system’s response to the disease. It targets individuals at high risk of familial or hereditary pancreatic ductal adenocarcinoma (PDAC). Early diagnosis of pancreatic cancer is crucial for improving patient prognosis and survival rates, as emphasized by the Pancreatic Cancer Action Network (PanCAN).
In a study on early diagnosis conducted in March 2021, the PanCan-d test demonstrated 99% specificity and 89% sensitivity in detecting early-stage pancreatic cancer (Stage I and II) . The clinical performance of the IMMray PanCan-d test has been validated in multiple studies, including a blinded validation study published in Clinical and Translational Gastroenterology in 2022 . The positive results from these studies further support the potential of the PanCan-d test for early detection of pancreatic cancer.
An article published in the Surgical Oncology Yearbook in early 2022 presented findings on 176 early-stage pancreatic cancer patients who underwent surgery and adjuvant chemotherapy between 2009 and 2014. These patients were followed up for a minimum of 5 years. The results revealed that the five-year overall survival rate (OS) was only 27%, and the survival rate without recurrence was merely 11%. This implies that nearly 90% of early-stage pancreatic cancer patients, even those who received postoperative adjuvant chemotherapy, still face the possibility of recurrence within one year or later after surgery. Furthermore, on January 12, 2023, the American Cancer Society (ACS) announced that the five-year survival rate for pancreatic cancer reached its highest historical level of 12%. This marks the first consecutive two-year increase since 2017. Despite a 5% improvement in survival rate over the past decade, a five-year survival rate of 12% remains the lowest among all common cancers. The report also estimated that in 2023, approximately 64,050 Americans are expected to be diagnosed with pancreatic cancer, representing a nearly 3% increase compared to 2022. Information disclosed by Immunovia suggests that around 10-15% of pancreatic cancer cases can be attributed to familial or hereditary factors.
According to a report by Mordor Intelligence, the global pancreatic cancer treatment and diagnosis market was valued at $36.8961 billion in 2021 and is projected to reach $56.5658 billion by 2027, with a compound annual growth rate (CAGR) of 7.43% from 2022 to 2027. The rising incidence of pancreatic cancer, supportive reimbursement policies, and high healthcare expenditures contribute to the expectation that the United States will maintain a significant market share in pancreatic cancer diagnostic testing.
