NETest Supporting Data

The NETest is a novel blood-based laboratory developed test (LDT), a molecular diagnostic, that provides sensitive and specific information with respect to a neuroendocrine tumor status. The test is unique in that it uses 51 neuroendocrine tumor gene transcripts and novel state-of-the-art molecular biomarker analyses developed by Wren scientists. This allows us to monitor neuroendocrine tumor gene activity levels. Four areas that the NETest has demonstrated clinical utility include as a diagnostic, as a prognostic, as a monitor of therapy and as a predictor of therapy.

A scientist pipetting DNA samples into a tube.

A. Use as a diagnostic:

The following manuscripts identify the NETest is more accurate (sensitive) than any other biomarker for the diagnosis of NET disease. These include initial and independent validation that the NETest is a bona fide NET diagnostic.

(1) Modlin I, Drozdov I, Kidd M: The identification of gut neuroendocrine tumor disease by multiple synchronous transcript analysis in blood. PLOS One 2013; e63364.

(2) Modlin I, Drozdov I, Alaimo D, Callahan S, Teixeira N, Bodei L, Kidd M: A multianalyte PCR blood test outperforms single analyte ELISAs for neuroendocrine tumor detection Endocrine Related Cancer 2014;21:615-628.

(3) Modlin I, Aslanian H, Bodei L, Drozdov I, Kidd M: A PCR blood test outperforms chromogranin A in carcinoid detection and is unaffected by PPIs. Endocrine Connections 2014; 3:215-23.

(4) Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. American Journal of Gastroenterology 2015; 110:1223-32.

(5) Filosso PL, Kidd M, Roffinella M, et al. The utility of blood neuroendocrine gene transcript measurement in the diagnosis of bronchopulmonary neuroendocrine tumours and as a tool to evaluate surgical resection and disease progression. Eur J Cardiothorac Surg. 2018.

(6) Liu E, Paulson S, Gulati A, et al. Assessment of NETest Clinical utility in a US Registry-based study. The Oncologist 2018.

B. Use as a prognostic:

The following manuscripts demonstrate that elevated NETest scores are associated with poor progression free survival and can be used to identify those in whom disease will progress. Low scores, in contrast, are concordant with disease stability.

(1) Pavel M, Jann H, Prasad V, Drozdov I, Modlin IM, Kidd M. NET blood transcript analysis defines the crossing of the clinical Rubicon: when stable disease becomes progressive. Neuroendocrinology 2016 Apr 15 (published online).

(2) Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. American Journal of Gastroenterology 2015; 110:1223-32.

(3) Genc CG, Jilesen APJ, Nieveen van Dijkum EJM, et al. Measurement of Circulating Neuroendocrine Transcript Levels (NETest) Facilitates Effective Detection of Disease Recurrence and Improves Follow-up Strategies After Curative Surgical Resection of Well-Differentiated Pancreatic Neuroendocrine Tumors. Annals Surgical Oncology 2018.

(4) Liu E, Paulson S, Gulati A, et al. Assessment of NETest Clinical utility in a US Registry-based study. The Oncologist 2018.