Interpace Diagnostics Group has completed its initial launch of PanDNA, a new product that stratifies patients' risk of developing pancreatic cancer based on three specific molecular criteria.
PanDNA was developed using the Company's proprietary database of results for over 15,000 patients with pancreatic cysts.
Annually, over 170,000 patients in the US are identified with pancreatic cysts via imaging studies and referred by Radiologists to a Gastroenterologist for further risk assessment. PanDNA is designed to aid in this assessment.
PanDNA was developed for those physicians and institutions that can perform and assess various components of the traditional PancraGen™ product themselves, e.g. cytology or Endoscopic Ultrasound (EUS) analysis.
For this specific group of Gastroenterologists, many of whom are affiliated with larger academic centers, their primary interest is in obtaining a more thorough understanding of the molecular features associated with their patients' cysts.
Interpace's PanDNA assigns risk for a cyst based on an accumulation of three molecular criteria: DNA quantity; an Oncogene Panel; and a Tumor Suppressor Gene Panel. A higher number of findings is an indication of a potentially higher risk prognosis.
The launch of PanDNA is being done in two separate phases. The initial phase, which is already underway, involves members of the Company's Scientific Advisory Board and others who have expressed an interest in using an approach like PanDNA in their own practices.
As part of this phase, the Company is requesting physicians to provide feedback on the ordering process, reports, and other aspects of the test.
At the same time, the Company is working with The Centers for Medicare & Medicaid Services (CMS) and others to develop policies and practices regarding billing and pricing.
With this input incorporated, the final version of the product is anticipated to be launched on or about October 15, which is the start of the Fall American College of Gastroenterology (ACG) conference being held in Las Vegas.
In addition, data used to support the development of the PanDNA product will be presented during the ACG meeting.
The core or standard PancraGen™ product, also known as "Integrated Molecular Pathology" (IMP), integrates multiple factors to determine the appropriate status of a given cyst including imaging, cytology, fluid chemistry, and several molecular markers.
The combined assessment of these features conducted by the Company's expert molecular pathologists results in a stratification of risk that ranges from benign to aggressive. PancraGen has been offered by the Company since 2008 and has been run on over 27,000 samples.
With the addition of PanDNA we anticipate increasing the universe of likely users of our pancreatic testing and services by up to 50% including expanded use of our current PancraGen assay based on initial interest and feedback from our target audience.
"This is an important milestone for Interpace," said Jack Stover, President and CEO of Interpace. "PanDNA represents a key innovation that we believe will be responsive to the market's needs and expand our growing G.I. business."
PancraGEN® is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN® is 90% accurate, according to clinical studies, enabling effective risk stratification of patients.
Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.