Why the NETest®?
The NETest is a non-invasive procedure that uses a blood sample to inform your doctor what the activity of your tumor is at the time your blood was drawn. It allows patients to avoid the radiation exposure and risks associated with imaging. NETesting is intended to aid in the identification of active disease and therefore provide an assessment of treatment responses in neuroendocrine tumor patients at the time of testing in conjunction with standard clinical assessment. NETesting is as easy as having your blood drawn, and provides clinicians and patients with the information to better manage treatment.
Neuroendocrine Disease Testing: A Molecular Diagnostic Tool
When disease recurrence occurs, a series of tests need to be undertaken to identify the location of the disease and to assess the extent and progress. Acquiring this information is critical in defining a new management strategy to prevent the disease from spreading. The NETest represents a molecular measurement of a variety of different gene transcripts in the blood (molecular information) which indicate the biological nature of the tumor and the extent of its progression. In addition, measurement of these values can be used to determine whether new treatment is effective or not. This information is critical both for the physician and the patient. It allows the former to adjust therapy appropriately to better manage the disease and provides the patient with added information to understand, in real-time, the status of their disease. Both clinicians and patients are therefore far better informed and supported. The patient has a more precise understanding of their condition and the clinician has an added tool to gauge the effectiveness of the therapy that is being administered.
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HOW CAN THE NETEST HELP ME IN THE MANAGEMENT OF NET DISEASE?
A1. DO I HAVE A NET AND HOW ACCURATELY DOES THE NETest DIAGNOSE IT?
- A meta-analysis of the accuracy of a neuroendocrine tumor mRNA genomic biomarker (NETest) in blood. Öberg K, Califano A, Strosberg JR, Ma S, Pape U, Bodei L, Kaltsas G, Toumpanakis C, Goldenring JR, Frilling A, Paulson S. Ann Oncol. 2020 Feb;31(2):202-212. doi: 10.1016/j.annonc.2019.11.003.
- Prospective Evaluation of the NETest as a Liquid Biopsy for Gastroenteropancreatic and Bronchopulmonary Neuroendocrine Tumours: An ENETS Centre of Excellence Experience. Malczewska A, Witkowska M, Wójcik-Giertuga M, Kuśnierz K, Bocian A, Walter A, Rydel M, Robek A, Pierzchała S, Malczewska M, Leś-Zielińska I, Czyżewski D, Ziora D, Pilch-Kowalczyk J, Zajecki W, Kos-Kudla B. Neuroendocrinology. 2020 Apr 24. doi: 10.1159/000508106.
- The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. Am J Gastroenterol. 2015 Aug;110(8):1223-32. doi: 10.1038/ajg.2015.160.
A2. HOW EFFECTIVE IS THE NETest IN GEP-NENs?
- NETest liquid biopsy is diagnostic of small intestine and pancreatic neuroendocrine tumors and correlates with imaging. Malczewska A, Witkowska M, Makulik K, Bocian A, Walter A, Pilch-Kowalczyk J, Zajęcki W, Bodei L, Oberg KE, Kos-Kudła B. Endocr Connect. 2019 Mar 1;8(4):442-53. doi: 10.1530/EC-19-0030.
- Blood Transcript Profiling for the Detection of Neuroendocrine Tumors: Results of a Large Independent Validation Study. van Treijen MJC, Korse CM, van Leeuwaarde RS, Saveur LJ, Vriens MR, Verbeek WHM, Tesselaar MET, Valk GD. Front Endocrinol (Lausanne). 2018 Dec 4;9:740. doi: 10.3389/fendo.2018.00740. eCollection 2018.
- Utility of a ready-to-use PCR system for neuroendocrine tumor diagnosis. Kidd M, Drozdov IA, Matar S, Gurunlian N, Ferranti NJ, Malczewska A, Bennett P, Bodei L, Modlin IM. PLoS One. 2019 Jun 27;14(6):e0218592. doi: 10.1371/journal.pone.0218592.
- The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. Am J Gastroenterol. 2015 Aug;110(8):1223-32. doi: 10.1038/ajg.2015.160.
A3. IS THE NETest EFFECTIVE IN BP-NENs?
- Molecular identification of bronchopulmonary neuroendocrine tumours and neuroendocrine genotype in lung neoplasia using the NETest liquid biopsy. Filosso PL, Öberg K, Malczewska A, Lewczuk A, Roffinella M, Aslanian H, Bodei L. Eur J Cardiothorac Surg. 2020 Jun 1;57(6):1195-1202. doi: 10.1093/ejcts/ezaa018
- NETest Liquid Biopsy Is Diagnostic of Lung Neuroendocrine Tumors and Identifies Progressive Disease. Malczewska A, Oberg K, Bodei L, Aslanian H, Lewczuk A, Filosso PL, Wójcik-Giertuga M, Rydel M, Zielińska-Leś I, Walter A, Suarez AL, Kolasińska-Ćwikła A, Roffinella M, Jamidar P, Ziora D, Czyżewski D, Kos-Kudła B, Ćwikła J. Neuroendocrinology. 2019;108(3):219-231. doi: 10.1159/000497037.
- 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. Filosso PL, Kidd M, Roffinella M, Lewczuk A, Chung KM, Kolasinska-Cwikla A, Cwikla J, Lowczak A, Doboszynska A, Malczewska A, Catalano M, Zunino V, Boita M, Arvat E, Cristofori R, Guerrera F, Oliaro A, Tesselaar M, Buikhuisen W, Kos-Kudla B, Papotti M, Bodei L, Drozdov I, Modlin I. Eur J Cardiothorac Surg. 2018 Mar 1;53(3):631-639. doi: 10.1093/ejcts/ezx386.
A4. CAN THE NETest IDENTIFY MICROMETASTATIC DISEASE?
- Blood mRNA Measurement (NETest) for Neuroendocrine Tumor Diagnosis of Image-Negative Liver Metastatic Disease. Malczewska A, Bodei L, Kidd M, Modlin IM. J Clin Endocrinol Metab. 2019 Mar 1;104(3):867-872. doi: 10.1210/jc.2018-01804.
HOW DOES THE NETest COMPARE TO OTHER BIOMARKERS?
- Prospective Evaluation of the NETest as a Liquid Biopsy for Gastroenteropancreatic and Bronchopulmonary Neuroendocrine Tumours: An ENETS Centre of Excellence Experience. Malczewska A, Witkowska M, Wójcik-Giertuga M, Kuśnierz K, Bocian A, Walter A, Rydel M, Robek A, Pierzchała S, Malczewska M, Leś-Zielińska I, Czyżewski D, Ziora D, Pilch-Kowalczyk J, Zajecki W, Kos-Kudla B. Neuroendocrinology. 2020 Apr 24. doi: 10.1159/000508106.
- Blood Transcript Profiling for the Detection of Neuroendocrine Tumors: Results of a Large Independent Validation Study. van Treijen MJC, Korse CM, van Leeuwaarde RS, Saveur LJ, Vriens MR, Verbeek WHM, Tesselaar MET, Valk GD. Front Endocrinol (Lausanne). 2018 Dec 4;9:740. doi: 10.3389/fendo.2018.00740. eCollection 2018.
- Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29
- A multianalyte PCR blood test outperforms single analyte ELISAs (chromogranin A, pancreastatin, neurokinin A) for neuroendocrine tumor detection. Modlin IM, Drozdov I, Alaimo D, Callahan S, Teixiera N, Bodei L, Kidd M. Endocr Relat Cancer. 2014 Aug;21(4):615-28. doi: 10.1530/ERC-14-0190.
- The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. Modlin IM, Kidd M, Bodei L, Drozdov I, Aslanian H. Am J Gastroenterol. 2015 Aug;110(8):1223-32. doi: 10.1038/ajg.2015.160.
HOW THE NETest DETERMINES THE SUCCESS OF SURGERY AND IDENTIFIES RESIDUAL DISEASE?
- Evaluation of circulating transcript analysis (NETest) in small intestinal neuroendocrine neoplasms after surgical resection. Laskaratos FM, Liu M, Malczewska A, Ogunbiyi O, Watkins J, Luong TV, Mandair D, Caplin M, Toumpanakis C. Endocrine. 2020 Apr 14. doi: 10.1007/s12020-020-02289-2.
- Circulating Neuroendocrine Gene Transcripts (NETest): A Postoperative Strategy for Early Identification of the Efficacy of Radical Surgery for Pancreatic Neuroendocrine Tumors. Partelli S, Andreasi V, Muffatti F, Schiavo Lena M, Falconi M. Ann Surg Oncol. 2020 Apr 6. doi: 10.1245/s10434-020-08425-6
- Measurement of circulating transcript levels (NETest) to detect disease recurrence and improve follow-up after curative surgical resection of well-differentiated pancreatic neuroendocrine tumors. Genç CG, Jilesen APJ, Nieveen van Dijkum EJM, Klümpen HJ, van Eijck CHJ, Drozdov I, Malczewska A, Kidd M, Modlin I. J Surg Oncol. 2018 Jul;118(1):37-48. doi: 10.1002/jso.25129.
- 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. Filosso PL, Kidd M, Roffinella M, Lewczuk A, Chung KM, Kolasinska-Cwikla A, Cwikla J, Lowczak A, Doboszynska A, Malczewska A, Catalano M, Zunino V, Boita M, Arvat E, Cristofori R, Guerrera F, Oliaro A, Tesselaar M, Buikhuisen W, Kos-Kudla B, Papotti M, Bodei L, Drozdov I, Modlin I. Eur J Cardiothorac Surg. 2018 Mar 1;53(3):631-639. doi: 10.1093/ejcts/ezx386.
- Blood measurement of neuroendocrine gene transcripts defines the effectiveness of operative resection and ablation strategies. Modlin IM, Frilling A, Salem RR, Alaimo D, Drymousis P, Wasan HS, Callahan S, Faiz O, Weng L, Teixeira N, Bodei L, Drozdov I, Kidd M. Surgery. 2016 Jan;159(1):336-47. doi: 10.1016/j.surg.2015.06.056.
CAN THE NETest IDENTIFY IF MY DISEASE IS PROGRESSING?
- Blood Molecular Genomic analysis predicts the disease course of GEP NET patients: a validation study of the predictive value of the NETest®. van Treijen MJC, van der Zee D, Heeres BC, Staal FCR, Vriens MR, Saveur LJ, Verbeek WHM, Korse CM, Maas M, Valk GD, Tesselaar M. Neuroendocrinology. 2020 Jun 3. doi: 10.1159/000509091.
- A meta-analysis of the accuracy of a neuroendocrine tumor mRNA genomic biomarker (NETest) in blood. Öberg K, Califano A, Strosberg JR, Ma S, Pape U, Bodei L, Kaltsas G, Toumpanakis C, Goldenring JR, Frilling A, Paulson S. Ann Oncol. 2020 Feb;31(2):202-212. doi: 10.1016/j.annonc.2019.11.003.
- NETest Liquid Biopsy Is Diagnostic of Lung Neuroendocrine Tumors and Identifies Progressive Disease. Malczewska A, Oberg K, Bodei L, Aslanian H, Lewczuk A, Filosso PL, Wójcik-Giertuga M, Rydel M, Zielińska-Leś I, Walter A, Suarez AL, Kolasińska-Ćwikła A, Roffinella M, Jamidar P, Ziora D, Czyżewski D, Kos-Kudła B, Ćwikła J. Neuroendocrinology. 2019;108(3):219-231. doi: 10.1159/000497037.
- Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29.
- 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. Filosso PL, Kidd M, Roffinella M, Lewczuk A, Chung KM, Kolasinska-Cwikla A, Cwikla J, Lowczak A, Doboszynska A, Malczewska A, Catalano M, Zunino V, Boita M, Arvat E, Cristofori R, Guerrera F, Oliaro A, Tesselaar M, Buikhuisen W, Kos-Kudla B, Papotti M, Bodei L, Drozdov I, Modlin I. Eur J Cardiothorac Surg. 2018 Mar 1;53(3):631-639. doi: 10.1093/ejcts/ezx386.
- NET Blood Transcript Analysis Defines the Crossing of the Clinical Rubicon: When Stable Disease Becomes Progressive. Pavel M, Jann H, Prasad V, Drozdov I, Modlin IM, Kidd M. Neuroendocrinology. 2017;104(2):170-182. doi: 10.1159/000446025.
CAN THE NETest TELL ME IF MY SOMATOSTATIN ANALOGUES ARE EFFECTIVE?
- Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29
- Circulating Transcript Analysis (NETest) in GEP-NETs Treated With Somatostatin Analogs Defines Therapy. Ćwikła JB, Bodei L, Kolasinska-Ćwikła A, Sankowski A, Modlin IM, Kidd M. J Clin Endocrinol Metab. 2015 Nov;100(11):E1437-45. doi: 10.1210/jc.2015-2792.
CAN THE NETest PREDICT IF PRRT WILL BE EFFECTIVE?
- PRRT genomic signature in blood for prediction of (177)Lu-octreotate efficacy. Bodei L, Kidd MS, Singh A, van der Zwan WA, Severi S, Drozdov IA, Cwikla J, Baum RP, Kwekkeboom DJ, Paganelli G, Krenning EP, Modlin IM. Eur J Nucl Med Mol Imaging. 2018 Jul;45(7):1155-1169.
- Measurement of circulating transcripts and gene cluster analysis predicts and defines therapeutic efficacy of peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors. Bodei L, Kidd M, Modlin IM, Severi S, Drozdov I, Nicolini S, Kwekkeboom DJ, Krenning EP, Baum RP, Paganelli G. Eur J Nucl Med Mol Imaging. 2016 May;43(5):839-851. doi: 10.1007/s00259-015-3250-z
IS PRRT WORKING?
- PRRT neuroendocrine tumor response monitored using circulating transcript analysis: the NETest. Bodei L, Kidd MS, Singh A, van der Zwan WA, Severi S, Drozdov IA, Malczewska A, Baum RP, Kwekkeboom DJ, Paganelli G, Krenning EP, Modlin IM. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):895-906.
INDEPENDENT VALIDATION STUDIES
- Sensitivity and Specificity of the NETest: A Validation Study. Al-Toubah T, Cives M, Valone T, Blue K, Strosberg JR. Neuroendocrinology. 2020 Jul 2. doi: 10.1159/000509866. Online ahead of print.
- Blood Molecular Genomic analysis predicts the disease course of GEP NET patients: a validation study of the predictive value of the NETest®. van Treijen MJC, van der Zee D, Heeres BC, Staal FCR, Vriens MR, Saveur LJ, Verbeek WHM, Korse CM, Maas M, Valk GD, Tesselaar M. Neuroendocrinology. 2020 Jun 3. doi: 10.1159/000509091.
- Evaluation of circulating transcript analysis (NETest) in small intestinal neuroendocrine neoplasms after surgical resection. Laskaratos FM, Liu M, Malczewska A, Ogunbiyi O, Watkins J, Luong TV, Mandair D, Caplin M, Toumpanakis C. Endocrine. 2020 Apr 14. doi: 10.1007/s12020-020-02289-2.
- ASO Author Reflections: Circulating Neuroendocrine Gene Transcripts (NETest): A Promising Biomarker for Pancreatic Neuroendocrine Tumours (PanNET). Partelli S, Falconi M. Ann Surg Oncol. 2020 May 27. doi: 10.1245/s10434-020-08464-z
- Circulating Neuroendocrine Gene Transcripts (NETest): A Postoperative Strategy for Early Identification of the Efficacy of Radical Surgery for Pancreatic Neuroendocrine Tumors. Partelli S, Andreasi V, Muffatti F, Schiavo Lena M, Falconi M. Ann Surg Oncol. 2020 Apr 6. doi: 10.1245/s10434-020-08425-6
- Prospective Evaluation of the NETest as a Liquid Biopsy for Gastroenteropancreatic and Bronchopulmonary Neuroendocrine Tumours: An ENETS Centre of Excellence Experience. Malczewska A, Witkowska M, Wójcik-Giertuga M, Kuśnierz K, Bocian A, Walter A, Rydel M, Robek A, Pierzchała S, Malczewska M, Leś-Zielińska I, Czyżewski D, Ziora D, Pilch-Kowalczyk J, Zajecki W, Kos-Kudla B. Neuroendocrinology. 2020 Apr 24. doi: 10.1159/000508106.
- A meta-analysis of the accuracy of a neuroendocrine tumor mRNA genomic biomarker (NETest) in blood. Öberg K, Califano A, Strosberg JR, Ma S, Pape U, Bodei L, Kaltsas G, Toumpanakis C, Goldenring JR, Frilling A, Paulson S. Ann Oncol. 2020 Feb;31(2):202-212. doi: 10.1016/j.annonc.2019.11.003.
- Blood Transcript Profiling for the Detection of Neuroendocrine Tumors: Results of a Large Independent Validation Study. van Treijen MJC, Korse CM, van Leeuwaarde RS, Saveur LJ, Vriens MR, Verbeek WHM, Tesselaar MET, Valk GD. Front Endocrinol (Lausanne). 2018 Dec 4;9:740. doi: 10.3389/fendo.2018.00740. eCollection 2018.
- Assessment of NETest Clinical Utility in a U.S. Registry-Based Study. Liu E, Paulson S, Gulati A, Freudman J, Grosh W, Kafer S, Wickremesinghe PC, Salem RR, Bodei L. Oncologist. 2019 Jun;24(6):783-790. doi: 10.1634/theoncologist.2017-0623. Epub 2018 Aug 29
THE DEVELOPMENT AND HISTORY OF THE NETest
- The Clinical Applications of a Multigene Liquid Biopsy (NETest) in Neuroendocrine Tumors Malczewska A, Kos-Kudla B, Kidd M, Drozdov I, Bodei L, Matar S, Oberg K, Modlin IM. Advances in Medical Sciences 65 (2020) 18–29.
- The Clinical Utility of Multigene Blood Analysis in the Diagnosis and Management of Neuroendocrine Tumors Modlin IM, Kidd M, Malczewska A, Drozdov I, Bodei L, Matar S, Chung KM. Endocrinol Metab Clin N Am 47 (2018) 485–504.
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