Nordic Life Science 1
uring the following years, the antibody technolog
y platform was further developed and crucial patents were submitted. A number of important milestones have been achieved throughout the years, including clinical trials and multicenter studies regarding pancreatic cancer diagnosis, becoming listed, and collaboration agreements. In 2017, the company established a US office for the subsidiary Immunovia Inc in Marlborough, MA, US. The next step is now the market introduction of the first test for early detection of pancreatic cancer, called IMMray PanCan-d, firstly in the US, followed by markets in Europe and Canada. Pancreatic cancer is one of the deadliest cancer forms, with a current five year survival rate from diagnosis of only five to eight percent. Each year, 338,000 people globally are diagnosed and the number is growing. “There are no other blood tests on the market for early detection of pancreatic cancer, so there is a large unmet medical need. The current diagnostic methods for detecting pancreatic cancer are imaging, biopsy and a type of blood test (serum CA 19-9) that is used in the post-surgical follow-up of patients. The imaging techniques include CT Scan, MRI and EUS, of which CT and MRI both have moderate sensitivity and low specificity. EUS has better sensitivity and specificity but involves a very invasive process. Biopsy is also a very invasive procedure that might cause severe illnesses such as acute pancreatitis,” Dahlen says. On March 29th 2021, the company reached their last development milestone before US commercialization. A blinded validation study data demonstrated that the IMMray PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/ hereditary controls and with a specificity/sensitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls. “The validation study was the final milestone and as soon as we get the CLIA-license we will begin to sell our test to this group on the US market. Thanks to the high specificity and sensitivity demonstrated in this group, we see the possibility to widen the patient group from patients having two close relatives with pancreatic cancer to patients with one close relative. There is also a need to change the inclusion criteria of the surveillance programs to include persons with one first degree relative,” says Dahlen. In addition, the company also announced improved performance of the test in a clinical retrospective study. “In this study, performed in Lund, we could see that we now are back on the same level of specificity and sensitivity that we saw in the commercial test model study and we have now performed what we expected to see in the verification study. These results will be confirmed very quickly in our laboratory in Marlborough and after that we will launch our test in the symptomatic group as well. This group consist of approximately 1 million persons in the US and with our test we will support gastro centres in providing accelerated and correct diagnosis to patients,” says Dahlen. mmunovia has set a long-term goal of 30% market penetration after reimbursement and widespread insurance coverage. They will market the test for distinct risk groups. “There is an increased risk of pancreatic cancer in the familial and hereditary risk group. Here we will market the test as a surveillance test. In the US there is about 100,000 people over the age of 45, that have two First Degree Relatives who have died from pancreatic cancer, and this population has a 20–30 fold increase in NORDICLIFESCIENCE.ORG 63