The US National Institutes of Health (NIH) will provide $4.5m in funding to conduct a study evaluating biomarker tests for monitoring cystic tumours of the pancreas.
Overseen by the director of Moores Cancer Center at the University of California San Diego Health Diane Simeone, the clinical programme – split into three studies – aims to detect cysts that develop into pancreatic cancer.
Pancreatic cystic neoplasms (PCNs) are tumors of the pancreas that are relatively common and have a low, but measurable risk of degeneration into pancreatic cancer. Identifying the risk of progression to malignancy can help prevent overtreatment with unnecessary procedures, along with aiding in early diagnosis when cancer does occur.
The first will look at the accuracy of blood-based biomarkers through a retrospective study of 200 blood samples that include both early-stage pancreatic cancer cases and controls. A second study will test the biomarker’s ability to detect early-stage pancreatic cancer in patients undergoing surgery to remove pancreatic cysts suspected to be cancerous while a third investigation will examine the same in those undergoing annual surveillance of cystic tumours.
The first study is expected to finish next year, with the other two slated to last around five years, according to Immunovia, whose next-generation blood-based test has been selected for inclusion.
Four institutions in the Pancreatic Cancer Early Detection (PRECEDE) Consortium will carry out the study. PRECEDE is an international group of experts seeking to increase survival for pancreatic cancer patients through improvements in detection, risk modelling, and prevention. The consortium, of which Diane Simeone is executive committee chair, says it has assembled the largest high-risk patient cohort.
Simeone stated: "In this grant, our goal is to validate an effective early detection blood test for pancreatic cancer in patients with cystic tumours of the pancreas.”
"We are eager to work with Immunovia on a blood test that can predict who needs surgery for a pancreatic cyst, and who can be safely monitored without the need for surgery, a critical unmet need for these patients."
Only a few days before Sweden-based Immunovia announced its test would be evaluated in the study, the company also unveiled it had filed a provisional patent application in the US to protect the test. Immunovia has remained tight-lipped on the technology housed within the test, saying only it is “blood-based” and works by detecting proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Shares in the company soared following the patent filing on 2 August, rising 47.5% by market open on the same day compared to market close the day before. Prices settled slightly by 5 August, though still up by 36.7% compared to the market open on 1 August. The company has a market cap of $113m.
The market for oncology diagnostics is projected to grow from $1.5bn in 2023 to $2.3bn by 2030, according to analysis by GlobalData.
Cynthia Stinchcombe, medical devices analyst at GlobalData, said: “The advancements in oncology diagnostics, fuelled by companies like Immunovia, signify a major step forward in the accurate and early detection of cancer. With the industry focusing on both established and emerging diagnosis options, the scope for oncology diagnostics is widening, offering a brighter future for those affected by these conditions.”
Immunovia will also conduct its own clinical validation study later this year to confirm the accuracy of the Immunovia test in detecting pancreatic cancer in a high-risk population. The company expects to roll out the device next year.
