Assay Shows Ability to Detect Pancreatic Cancer in People at High Risk

An immunoassay was able to detect pancreatic cancer in high-risk individuals and with high sensitivity and specificity, researchers reported.

In a validation study, the multiplex IMMray PanCan-d assay demonstrated a specificity of 98% and sensitivity of 87% in identifying pancreatic ductal adenocarcinoma (PDAC) among individuals at increased genetic or familial risk, reported Thomas King, MD, PhD, of developer Immunovia in Marlborough, Massachusetts, and colleagues.

For detecting stage I/II disease, the assay showed a specificity of 98% and sensitivity of 85% in these high-risk individuals, and excluding Lewis antigen null samples improved the accuracy, according to findings in Clinical and Translational Gastroenterology.

Factors such as age, gender, or smoking status did not appear to affect the results of the serum-based test.

“The high specificity is promising and proof of principle that biomarker assays could be used to help clinical decision-making in identifying early pancreatic cancer,” said Andrew Hendifar, MD, of Cedars-Sinai Medical Center in Los Angeles, who was not involved in the study.

The 5-year survival rate in pancreatic cancer is below 10%. Most patients with early-stage disease remain asymptomatic or have only non-specific symptoms, and there are no reliable options for early detection, King’s group explained. As a result, diagnoses are often made at a later stage when the cancer is no longer operable.

IMMray PanCan-d combines eight serum biomarkers with CA19-9 to generate a risk-level signature.

“The key to improve survival is early detection during a potentially curable stage,” the group wrote. “Low or negative CA19-9 expression in individuals who are genotypically Lewis antigen null (i.e., le/le with mutations in both copies of the FUT3 gene) further limits the reliability of this biomarker for PDAC detection.”

For their study, they examined serum samples from 586 adults: 167 with PDAC (median 70 years, 58% male), 203 at high-risk for familial PDAC from the PanFAM clinical trial (median 59 years, 36% male), and a control group of 216 healthy adults (median 49 years, 51% male).

Histologically confirmed PDAC blood samples were collected for processing prior to surgery or adjuvant treatment, and lab personnel were blinded to the identity of the serum samples. Samples were collected using standard protocols with storage conditions of -80°C and thawed for analysis within 2 years of collection.

Lewis null samples were defined as those with a CA19-9 protein value of 2.5 U/mL or below. Among adults with PDAC, 56 samples were stage I/II.

For the group at high risk for familial PDAC, 28% had a prior history of cancer but were in remission or cured before joining the study, 25% had clinically suspected intraductal papillary mucinous neoplasms, and 27% had other pancreatic abnormalities.

Study limitations, the researchers noted, included that they did not conduct a clinical utility assessment; that the demographics varied substantially among groups, with most PDAC participants being from Europe while those in the high-risk group were mostly from the U.S.; and that 10% of the samples showed borderline results.