Diagnostics company Immunovia filed for patent protection around its protein biomarker combination and testing method and plans to join a $4.5 million study of cancer biomarker tests for pancreatic cystic tumors.
The National Institutes of Health (NIH) study will further validate and study Immunovia's pancreatic cancer test in an important risk group where pancreatic cystic tumors have a measurable risk of progression into pancreatic cancer, CEO Jeff Borcherding said via LinkedIn. In an email to LabPulse, Borcherding said the test is being investigated to use on a periodic basis (e.g., annually) to monitor an incidental finding of a cystic tumor, to detect malignant changes.
The company has completed the research and product development phases of the test, Immunovia said in a business update on Monday, August 5, adding that it has also finalized the set of biomarkers and defined the algorithm used to generate test results.
Immunovia recently announced a clinical laboratory move from Marlborough, MA, in May, to a new facility in North Carolina's Research Triangle Park (RTP), to be led by Dr. Lisa Ford as laboratory director. The team in RTP will focus on confirming the analytical validity of the protein assays for Immunovia's next-generation blood test using an enzyme-linked immunosorbent assay (ELISA) platform, according to the company.
The ELISA method shifts Immunovia's testing method away from the earlier IMMray version. The company said transition to ELISA assays means the laboratory can generally process a patient sample the same day it is received, whereas the IMMray PanCan-d test required two to three days of processing. The switch to ELISA will also reduce labor costs, and all reagents and supplies will be sourced externally, according to the company.
Immunovia's initial blood test showed sensitivity of 75% and specificity of 98%, the company reported. However, the latest version of the test "significantly" outperformed the CA19-9 biomarker commonly used to detect pancreatic cancer.
"By leveraging additional patient samples with more detailed clinical information and through more sophisticated statistical modeling, we increased test performance to 85% sensitivity and 98% specificity in detecting stage 1 and 2 pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer," Immunovia said.
Additionally, "a specificity of 98% means this new test should only return a false positive result once for every 50 people tested who do not have pancreatic cancer," Immunovia noted.
Dr. Diane Simeone of the University of California San Diego Health and director of Moores Cancer Center said that the NIH study addresses a critical unmet need for patients with pancreatic cysts.
“In this grant, our goal is to validate an effective early detection blood test for pancreatic cancer in patients with cystic tumors of the pancreas,” Simeone said in a news release. “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."
Simeone is the principal investigator and lead of Precision Promise, a national clinical trials consortium focused on next-generation clinical trials for people with pancreatic cancer. She is also the founder of the Pancreatic Cancer Early Detection (PRECEDE) Consortium, an international consortium established to drive the early detection of pancreatic cancer.
Branch-duct intraductal papillary mucinous neoplasms, the most common incidentally discovered pancreatic cystic neoplasms (PCNs), have a risk of malignancy approaching 15% within 15 years of diagnosis, Immunovia noted. Accurate identification of PCNs and determining their risk for progression to invasive pancreatic cancer is important to prevent both overtreatment with unnecessary procedures and missed opportunities for early cancer diagnosis.
The NIH study will assess the use of biomarker tests to detect pancreatic cysts that develop into pancreatic cancer. The first study should be completed in 2025, Immunovia said, with the overall clinical program consisting of three complementary studies:
- Study 1 will define the performance and accuracy of blood-based biomarkers through a retrospective study of 200 blood samples that include early-stage pancreatic cancer cases and controls.
- Study 2 will evaluate the ability of the biomarker tests to detect early-stage pancreatic cancer in patients undergoing surgery to remove pancreatic cysts suspected to be cancerous.
- Study 3 will examine biomarker performance for detection of early-stage cancer in a group of individuals undergoing annual surveillance of cystic tumors.
