NEW YORK (GenomeWeb) – Molecular diagnostics developer Interpace Diagnostics has announced the publication of a multicenter study demonstrating that its PancraGen molecular test for pancreatic cysts improved outcomes for patients and helped doctors monitor patients with benign disease.
Interpace is the molecular diagnostics-focused nucleus of the former PDI biomedical commercialization and marketing services business, which the firm divested late last year. Jack Stover, Interpace's interim president and CEO, noted that PDI was in the contract sales organization business, with expertise in selling and marketing mostly pharmaceuticals to primary care physicians and specialists.
"Over the years, we gained an expertise in diagnostic products, and in promoting and marketing them as well," he said, adding that regulatory changes and risks associated with off-label promotion prompted the shift in business focus. "We believe the best opportunity was really in the molecular diagnostic space," Stover said.
Having acquired two microRNA tests from Asuragen and the assets of RedPath Integrated Pathology in 2014, the firm is now a stand-alone molecular diagnostics company.
The PancraGen product was acquired with the RedPath acquisition, Stover noted, and one of the Assuragen tests was also a pancreatic cyst assay.
Published last week, the Diagnostics Pathology study — which was funded in part by Interpace and involved researchers from Thomas Jefferson University, and Georgetown University Hospital — followed 492 patients for up to seven years to determine whether the assay improved patient management, especially for patients with cysts diagnosed as benign.
Most cysts are benign, but some can develop into pancreatic cancer, which has a very high mortality rate. On the other hand, pancreatic surgery to remove cysts is costly, stressful, and associated with risks such as lifelong morbidity. It can also cause death in 2 percent of cases, while more than 80 percent of cysts removed by surgery end up showing benign disease.
The study relied on a national pancreatic cyst registry that was set up with the objective of obtaining long-term follow-up on the test, Interpace CSO Syd Finkelstein told GenomeWeb.
"Specifically, [the study] let us understand clinical utility and how physicians were using the test, whether the decisions they made based on the added information from molecular analysis would be favorable to the individual patient, and what impact it would have for the healthcare system, especially in terms of cost," Finkelstein said. The test also gives physicians assurance to better manage benign disease, he said.
The test has been available since 2004. It is performed in the firm's College of American Pathologists- and CLIA-certified labs, located in Pittsburgh and New Haven, Connecticut.
Current pancreatic cyst guidelines, such as ones published in 2012 in the journal Pancreatology, "are weighted in such a way that many patients qualify for surgery in order to avoid missing cancer, but the price that patients pay is many of them prove not to have cancer," Finkelstein said.
A more recent guideline published last year by the American Gastroenterological Association addressed the need to reduce surgeries, he added, but it was drawn up in 2014, before long-term data on PancraGen was available. The guidelines do not endorse molecular testing per se, but do encourage physicians to choose surveillance when possible, Finkelstein said.
In the study, PancraGen was able to offer 55 percent of patients surveillance instead of guideline-recommended surgery, without an increase in cancers being missed.
The PancraGen test was originally covered by Medicare in 2007, is now being covered by an independent Blue Cross Blue Shield plan, and last month it was issued non-conditional coverage by Medicare administrative carrier Novitas Solutions.
Stover said the firm is now getting a lot of response about the new publication from the reimbursement community, noting that this is the seminal study they have been looking for.
PancraGen is a PCR- and sequencing-based test that looks at molecular changes which could indicate malignancy, but also ones that could support benign disease, said Finkelstein. He noted that it is not meant to be a first-line test, but is used when there is indeterminacy after initial first-line clinical tests.
Clinicians send "a small amount of the aspirated pancreatic or duct fluid" to the firm, while the remainder of the specimen is usually processed for cytology and chemistry by the hospital lab.
The test assesses oncogene point mutations associated with pancreatic cancer, tumor suppressor gene loss, and the quantity and quality of DNA from pancreatic cyst fluid. The test also measures clonality, or the proportion of cells affected by a particular mutation.
"We develop a fairly rich profile of molecular information, and then we take that and add it to the first-line clinical information ... [such as] imaging, the radiological and ultrasound pictures of the cysts, the cytology, and the cyst fluid biochemistry," Finkelstein said.
Ultimately, combined with these assessments, the PancraGen test "gives the physician not only the understanding of whether there are changes that indicate benign or malignant disease, but it also indicates the risk likelihood that over time the lesion will progress toward cancer," Finkelstein noted.
Indeed, a recent study in the journal Endoscopy suggested that an integrated molecular pathology approach "more accurately determined the malignant potential of pancreatic cysts than a ... 2012 guideline management criteria model." It further noted the strategy may improve patient management by enabling "more relaxed observation" in patients meeting surveillance criteria, and that it "can more accurately differentiate between the need for surveillance or surgery."
The PancraGen test has been run approximately 25,000 times since 2004, and the firm has seen an increase over time in the use of the test, Finkelstein confirmed.
Greg Richard, the firm's senior vice president of commercial services, further pointed out that more than 400 physicians have ordered and utilized the test.
Interpace also has a sales team of 10 dedicated gastrointestinal sales specialists deployed nationally, Richard said. This team focuses on the discrete group of physicians in the GI space that does endoscopic ultrasound, and will now add the data from the Diagnostics Pathology study to the sales toolkit.
Competitors in the space have molecular tests that are mostly focused on identifying cancer only and can't be used to manage benign disease, Finkelstein said, and this gives PancraGen an edge.
The firm also has two tests for thyroid conditions. The ThyGenX test was acquired in August of 2014 from Asuragen and uses next-generation sequencing to diagnose thyroid cancer from thyroid nodules. The ThyraMIR test was launched last April, and is a classifier test that performs diagnosis using a proprietary gene expression assay.
The latter "competes very favorably, and actually is beating the largest competitor in the classifier space, which is Veracyte's test, Affirma," Richard said.
The firm's thyroid testing business is more recent, but is growing in excess of 30 percent month-over-month, he added.
ThyGenX is covered by a local coverage determination (LCD) with Novitas Solutions, since that is the jurisdiction the lab is in, and it is also covered "pretty much across the board with most of the commercial plans," Richard said. For ThyraMIR test, the firm is working on an LCD with Novitas, anticipates Medicare coverage early this year, and it is undergoing the same process for the other commercial plans as well.
Additionally, in the pipeline is a test for Barrett's esophagus, a condition that can progress to stomach cancer. That product was also developed initially at RedPath.
"All of the assays have the ability to provide physicians information both on the benign nature of the lesions they are looking at as well as the malignant nature, and so are designed to help best manage individual patients for the unique changes in each, and at the same time to result in a significant healthcare savings," Finkelstein said.