The NETest

Abstract

The neuroendocrine neoplasms test (NETest) is a multianalyte liquid biopsy that measures neuroendocrine tumor gene expression in blood. This unique signature precisely defines the biological activity of an individual tumor in real time. The assay meets the 3 critical requirements of an optimal biomarker: diagnostic accuracy, prognostic value, and predictive therapeutic assessment. NETest performance metrics are sensitivity and specificity and in head-to-head comparison are 4-fold to 10-fold more accurate than chromogranin A. NETest accurately identifies completeness of surgery and response to somatostatin analogs. Clinical registry data demonstrate significant clinical utility in watch/wait programs.

Unmet Needs in Functional and Nonfunctional Pancreatic Neuroendocrine Neoplasms

“…Only recently is this approach being increasingly used in patients with sporadic, asymptomatic NF-PanNENs [19-21, 23, 48]. This recommendation is not without controversy, with some authors advocating surgery for all PanNENs, whereas others support the conclusion that small, asymptomatic PanNENs are good candidates for surveillance [19-21, 49-52]. …”

“…At present there are limited tools which identify which of the small, asymptomatic PanNENs will grow, and therefore the approach generally used is to serial image this tumor [19-21, 49-51]. There also is not complete agreement on what imaging modality should be used.…”

“…Increasingly, patients with small (≤2 cm), asymptomatic, NF-PanNENs are not operated on, and instead a watch and wait approach is being increasingly used [20-23]. This approach has raised a number of queries, such as how to properly follow these patients, what imaging studies to use, and what are the best criteria to determine the need for surgery or to watch and wait [19-23]. …”

“…This recommendation is based on the findings that NF-PanNENs of this size are not associated with increased mortality in MEN1 patients, many do not grow or show aggressive behavior, and these patients cannot be completely cured of PanNENs, because they all have small, microscopic NF-PanNEN tumors throughout the gland and only 0–12% ever become symptomatic [5, 11, 12, 45-47]. Only recently is this approach being increasingly used in patients with sporadic, asymptomatic NF-PanNENs [19-21, 23, 48]. This recommendation is not without controversy, with some authors advocating surgery for all PanNENs, whereas others support the conclusion that small, asymptomatic PanNENs are good candidates for surveillance [19-21, 49-52].…”

“…While there are a number of liquid tumor markers that show promise (NETEST, circulating tumor DNA assessment, etc.) at present, they are not approved for routine use [19]. …”