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Interpace Pushes Pancreatic Cancer Assay Toward Expanded Applications, Plans Shift to NGS


NEW YORK (GenomeWeb) – Interpace Diagnostics has been pushing to expand the use of its PancraGen test beyond its initial indication — analyzing fluid from pancreatic cysts — to providing the same molecular information for samples from biliary strictures and solid pancreatic lesions.

Greg Richard, Interpace's chief commercial officer, said this week that this expanded indication, or use case, for the assay, coupled with a recently revamped sales team, has led to more than a year's worth of sequential quarterly volume growth, as the firm prepares now to transition the test — most likely next year — from its current Sanger sequencing methodology to an NGS platform.

"We don't break out numbers for the test when we report financial results, but I can tell you that we have now had 14 quarters of consistent [volume] growth, and the second quarter this year was a record for us," he said.

According to Richard, the push to broaden the use of PancraGEN from analysis of cyst fluid only to other pancreatobiliary sample types represents a synthesis of Interpace's commercial drive to increase the market for the test, and the advice of clinicians and researchers, who had been using the assay in their practices, that it might have a broader utility.

A molecular cancer risk classifier, PancraGEN was initially developed for the analysis of fluid that is removed as part of the management of patients with pancreatic cysts that a doctor suspects could harbor a malignancy.

Only a small number of pancreatic cysts turn out to be cancerous, but because pancreatic cancer has such dismal survival numbers, doctors and patients are hesitant to forego surgery, leading to a raft of unnecessary procedures. Enter PancraGEN.

Professional guidelines have only recently begun to embrace molecular testing to help identify patients with pancreatic cysts or other suspect lesions who can avoid surgery in favor of surveillance. But Richard said that the most recent updates have been very positive for Interpace.

In its announcement last week that PancraGEN had been expanded to work with solid lesions and biliary structures, the company highlighted that the National Comprehensive Cancer Network's most recent guidelines for hepatobiliary cancers recommend molecular testing in symptomatic patients with biliary obstruction or suspicious imaging in order to diagnose the presence of cholangiocarcinoma and help select a treatment pathway.

New American College of Gastroenterology Guidelines for the management of primary sclerosing cholangitis similarly recommend molecular testing in order to exclude the diagnosis of cholangiocarcinoma.

For its part, Interpace has been working with researchers to collect evidence for broader utility of the test and has so far published three studies in the peer-reviewed literature supporting the ability of the test to assess not just pancreatic cysts, but also biliary samples.

A little more than a year ago, investigators from Columbia University working with the company published a study in Clinical Gastroenterology and Hepatology, demonstrating that adding PancraGEN's mutational analyses, as well as FISH, to standard cytology, "significantly increased the level of sensitivity" with which they could detect malignancy in biliary strictures without increasing false positives.

Another group at Washington University in St. Louis has also performed a study to compare the sensitivity and accuracy of cytology plus FISH versus cytology plus DNA analysis with positive results for the molecular approach, Richard said.

And earlier this year, researchers from Interpace and from St Joseph Hospital Medical Center in Arizona published a report in the Journal of the Pancreas examining the performance of the company's mutation profiling in clinical practice and its impact on management in solid pancreaticobiliary patients with indeterminate cytology.

According to the authors, the use of PancraGEN improved diagnostic accuracy in 232 patients with indeterminate cytology, "increased clinician confidence in management recommendations, and resulted in more conservative management in 10 percent of patients."

As it continues to work to persuade clinicians of the value of its test, both for assessing pancreatic cysts, and this new larger category of lesions, Richard said that Interpace is now also planning to make a full commercial launch of the second test it has built on what it calls its Pathfinder platform, which is the same one that supports PancraGEN.

This assay, BarreGEN, is designed to help physicians assess the risk that a patient with Barrett's Esophagus has of progressing to esophageal cancer. Currently, the test is being used by a number of institutions as part of a clinical evaluation program. But Richard said that the company is now getting close to the point where it would begin to market the assay commercially.

At the same time, he said, Interpace is working to transition PancraGEN from its existing PCR and Sanger sequencing-based platform to next-gen sequencing.

According to Richard, that transition opens the possibility for even more opportunities to expand the utility of PancraGEN, for example, by allowing more targets to be added to the test that could aid doctors in assessing things like disease aggressiveness, or other aspects of a patient's prognosis.

Further down the line, considering the very rapid expansion of noninvasive cancer technologies in recent years, Richard said that Interpace is also conducting research into whether it can apply its genomic approaches without the need for cyst or tissue biopsy samples — recognizing that it may need to compete in the future with approaches that determine the risk of, or presence, of a cancer using a simple blood sample.

"Obviously we recognize that fine needle aspiration is just that, an invasive procedure, so anything that can be done to eliminate that for patients, we want to be able to try to do that, and so we are looking into ways we can adapt basic underlying technology to so-called liquid biopsies," he said.