Interpace Biosciences Inc. (IDXG)

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Abstract from Poster 232 being presented this weekend at ACG 2016 scientific meeting....


https://www.eventscribe.com/2016/ACG/

Program Number: P232
Day / Time: Sunday, Oct 16, 3:30 PM – 7:00 PM
Integrated Molecular Pathology Analysis of Pancreatic Cystic Lesions Changes EUS Gastroenterologist Management

Category: Endoscopy
Jose Nieto, DO, FACG1, Sara Jackson, PhD2, Nicole Toney, MPH2, Ali Lankarani, MD1
1. Borland Groover Clinic, Jacksonville, FL; 2. Interpace Diagnostics Corporation, Pittsburgh, PA

Introduction: Integrated molecular pathology (IMP) is a multi-parameter test for pancreatic cystic lesions. IMP measures key tumor suppressor gene mutations, oncogene mutations, and elevated DNA levels, with those measurements assessed in the context of the cysts’ clinical manifestation and fluid properties. IMP ultimately classifies cystic lesions as low or high risk for future malignancy. We aimed to determine if IMP results change endoscopic ultrasound (EUS) Gastroenterologist management recommendations.

Methods: Two EUS Gastroenterologists reviewed 220 de-identified, real-world patient cases. Cases included 118 with no worrisome features (WF), 53 with one WF and 49 with two WF, all randomly selected from a database of 12,331 cases. WF included cyst size >3cm, duct dilation >1cm, or suspected solid component. Physicians first reviewed EUS, cytology and fluid chemistry result reports, recording their management recommendations for surgery or surveillance and length of surveillance. After 3 months blinding, they reviewed the exact same result reports with the addition of corresponding real-world IMP (PancraGEN, Interpace Diagnostics) result reports, again recording their recommendations. McNemar’s test measured statistical significance of changes.

Results: 52% (114/220) of management recommendations changed after viewing IMP test results. Management recommendations changed to more relaxed surveillance in 34% (75/220) of cases (p < 0.0002), with 97% (73/75) having a low risk IMP results. Recommendations were changed to closer surveillance or surgery in 18% (39/220) of cases (p=0.006), with 69% (27/39) of these cases having a high risk IMP results. In cases with no WF, close surveillance or surgery of patients was recommended in 37%; after viewing IMP results, this was reduced to only 14%. In cases with one WF, close surveillance or surgery of patients was recommended in 60%; after viewing IMP results, this was reduced to 45% with changes occurring most often for large cysts. In cases with two WF, close surveillance or surgery of patients was recommended in 69%; after viewing IMP results, this was reduced to 61%, with changes occurring only for large cysts with suspected solid components.

Discussion: IMP results significantly change EUS physician management recommendations. IMP low risk diagnoses often result in longer surveillance intervals for patients. IMP high risk diagnoses often result in closer surveillance or surgery recommendations.

Supported by Industry Grant: No

Disclosures: Does Disclose
Sara Jackson, PhD – Interpace Diagnostics: Employee
Nicole Toney, MPH – Interpace Diagnostics Corporation: Employee

Citation: Jose Nieto, DO, FACG; Sara Jackson, PhD; Nicole Toney, MPH; Ali Lankarani, MD. INTEGRATED MOLECULAR PATHOLOGY ANALYSIS OF PANCREATIC CYSTIC LESIONS CHANGES EUS GASTROENTEROLOGIST MANAGEMENT. Program No. P232. ACG 2016 Annual Scientific Meeting Abstracts. Las Vegas, NV: American College of Gastroenterology.