Interpace Diagnostics Group Inc (NASDAQ:IDXG) announced the data presented in six posters at this week’s Digestive Disease Week (DDW) meeting held May 6th-9th at the McCormick Center in Chicago, Illinois.
The results presented in three of the posters support the clinical utility of PancraGEN® in assessing long-term risk of malignancy in pancreatic cystic lesions and stress the importance of using DNA analysis to better understand risk of cancer in cysts with worrisome imaging or fluid chemistry features that are not definitive for cancer. Together, the results are supported by data from nearly 1000 patients who underwent PancraGEN testing, including 370 patients who had multiple PancraGEN tests over a 4- year period. These results are consistent with the growing body of evidence that suggests PancraGEN provides insights to physicians regarding their patients’ risk of cancer that they are unable to glean from traditional parameters.
The results presented in the additional three posters support the clinical utility of PancraGEN as an ancillary test for solid lesions of the pancreas and bile duct using the company’s unique method for testing free-DNA obtained from bile duct brushings and fine needle aspirates. Together, the results were supported by data from nearly 350 patients. Notably, a prospective study of 100 patients reported that ancillary PancraGEN testing enhanced detection of cancer by 30% over the use of only traditional cytology testing alone. Furthermore, a study of 232 patients who had PancraGEN testing as part of their standard of care concluded that the use of PancraGEN as an ancillary test to cytology improves diagnostic accuracy for cancer and importantly, impacts physician decision making. Given low risk PancraGEN results, physicians were more likely to recommend active surveillance with higher confidence and had higher consensus for such recommendations.
The results presented were generated by a collaborative group of renowned centers, including:: Washington University, St. Louis, Missouri; University of Colorado, Aurora, Colorado; Arizona Center for Digestive Health, Phoenix, AZ; St Joseph Hospital Medical Center, Phoenix, AZ ; Creighton University School of Medicine; Emory University School of Medicine, Atlanta, GA; Columbia University Medical Center, New York, NY; Yale University, New Haven, CT; University of Southern California, Los Angeles, CA.
The posters presented include:
- “DNA Analysis of Pancreatic Cystic Fluid has Incremental Predictive Value in Assessing Future Risk of Malignant Outcomes”
- “Carcinoembryonic Antigen (CEA) Level in Cyst Fluid of Pancreatic Cyst has Poor Test Reliability and Should not be Used in Categorizing Incidental Pancreatic Cystic Lesions”
- “Being More Confidently Conservative: Mutational Profiling of Non-diagnostic Cytology Samples in Patients with Solid Pancreato-biliary Lesion (SPL) Impacts Clinical Decision Making”
- “PCR Based Mutation Profiling of Free DNA Enhances Cytology and FISH Based Detection of Malignancy in Patients with Biliary Structures Undergoing ERCP: A Prospective Study”
- “Prospective Molecular Mutational Analysis of Stent Supernatant in the Characterization of Benign and Malignant Biliary Strictures, an Interim Analysis”
- “High variability in serial pancreatic cyst fluid characteristics suggests that longer intervals of surveillance may be warranted“
According to Dr. Syd Finkelstein, Chief Medical & Scientific Officer of Interpace, “the results from our ongoing research in collaboration with numerous highly regarded institutions clearly supports the clinical utility of PancraGEN and demonstrates that PancraGEN can have a positive impact on physician decision making providing them a high degree of confidence in their treatment approach.”
Shares of Interpace Diagnostics are up nearly 5% in pre-market trading. IDXG has a 1-year high of $19.80 and a 1-year low of $0.70. The stock’s 50-day moving average is $2.41 and its 200-day moving average is $2.28.
Interpace Diagnostics Group, Inc. provides commercialization services to biopharmaceutical companies. It focuses on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for patient diagnosis and management. The company offers commercialized molecular tests which include PancraGen, ThyGenX, and ThyraMIR.