--- title: NTRK Fusion Testing for New Therapies description: Neurotrophic tyrosine receptor kinases (NTRK) can become abnormally fused to other genes resulting in growth signals that can lead to cancer in many organs of the human body. TRK gene fusion-based cancers are rare but present in pediatric and adult cancers such as lung, thyroid, colon, etc. image: https://blog.seracare.com/hubfs/Imported_Blog_Media/NTRK_Cancer_Types.jpg --- ![logo](https://seracare.com/Content/themes/Skin_Default/images/lgc_logo.png) SeraCare is part of LGC Clinical Diagnostics - [Learn More](https://www.lgcclinicaldiagnostics.com/) [![SeraCare](https://blog.seracare.com/hs-fs/hubfs/0.%20Logos/SeraCare/SeraCare.png?width=400&name=SeraCare.png "SeraCare")](https://www.seracare.com) - [Home](https://blog.seracare.com/ngs) - [About](https://digital.seracare.com/about-blog) - [News and Events](http://www.seracare.com/NewsEvents/NewsCenter/tabid/354/Default.aspx) - [Contact](http://www.seracare.com/Contact/tabid/366/Default.aspx) ## [Diagnostic Precision](https://blog.seracare.com/) A SeraCare blog focused on precision medicine and advanced clinical diagnostics Choose your Article Focus | [All](https://blog.seracare.com/molecular-serology-blog) | [NGS](https://blog.seracare.com/topic/ngs) | [Molecular & Serology](https://blog.seracare.com/molecular-serology-blog/tag/molecular-serology) # NTRK Fusion Testing for New Therapies Posted by [Omo Clement, PhD](https://blog.seracare.com/ngs/author/omo-clement-phd) on Feb 6, 2019 12:00:00 AM Neurotrophic tyrosine receptor kinases (NTRK) can become abnormally fused to other genes resulting in growth signals that can lead to cancer in many organs of the human body. TRK gene fusion-based cancers are rare but present in pediatric and adult cancers such as lung, thyroid, colon, etc. (see, e.g., Figure 1). Anti-tumor drugs that target NTRK fusions have been shown to be largely effective across many tumor types regardless of patient age (adult or pediatric). ![NTRK_Cancer_Types](https://blog.seracare.com/hs-fs/hubfs/Imported_Blog_Media/NTRK_Cancer_Types.jpg?width=600&name=NTRK_Cancer_Types.jpg) *Figure 1: Estimated frequency of NTRK gene fusion in specific tumor types*.[\[1\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftn1) New selective and targeted tyrosine kinase receptor inhibitor of the tropomyosin receptor kinases TrkA, TrkB, and TrkC are either in developmental stage ([Entrectinib](https://www.thestreet.com/story/13035800/1/ignyta-receives-orphan-drug-designation-from-fda-for-entrectinib-for-the-treatment-of-molecularly-defined-subsets-of-non-small-cell-lung-cancer.html))[\[2\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftn2) or recently approved Vitrakvi® ([Larotrectinib](https://ir.loxooncology.com/press-releases/2378241-Fda-approves-vitrakvi-larotrectinib-the-first-ever-trk-inhibitor-for-patients-with-advanced-solid-tumors-harboring-an-ntrk-gene-fusion12))[\[3\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftn3) for treatment of locally advanced or metastatic solid tumors with NTRK fusions without a known resistance mutation.[\[4\]](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm) However, there is a dearth of NTRK fusion genes in many traditional solid tumor-based NGS targeted assays, which makes identifying patients that will benefit from these drugs by NGS testing a challenge. It also means that patient samples harboring NTRK fusions are extremely rare, thus hampering IVD development and compromising analytical validation according to CAP and CLIA guidelines.   NGS IVD vendors such as Illumina, Thermo Fisher, Archer, and others are expanding their NGS assays to incorporate RNA fusion analysis for NTRK genes. These new NGS assays will require analytical and clinical validation to support patient testing and eligibility for these anti-tropomyosin TKIs.  The use of highly multiplexed, patient-like reference samples containing NTRK fusion genes will be critical in the development, validation and clinical testing by NGS assays of solid tissue biopsies (FFPE) of metastatic solid tumor patients potentially harboring NTRK gene fusions in clinical trial stratification and targeted therapeutic treatments. The availability of designed NTRK quality control materials will immediately help overcome the lack of NTRK patient samples. Today, the key need is designing and manufacturing solid tumor FFPE RNA NTRK fusion reference standards under ISO 13485 (cGMP) to support clinical testing laboratories looking to bring on board NTRK fusion testing assays as companion diagnostic or complementary tests for these classes of anti-tropomyosin TKIs. SeraCare, in partnership with Bayer, has recently developed a panel of [15 RNA-based NTRK fusion genes in an FFPE format](https://www.seracare.com/Seraseq-FFPE-NTRK-Fusion-RNA-Reference-Material-0710-1031/).[\[5\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftn5) This reference standard contains NTRK1, NTRK2, and NTRK3 fusion genes with known actionable fusion partners in the TRK pathway. *![NTRK fusion gene list](https://blog.seracare.com/hs-fs/hubfs/Imported_Blog_Media/NTRK%20fusion%20gene%20list.png?width=800&name=NTRK%20fusion%20gene%20list.png)* *Figure 2: List of NTRK fusions in the newly released Seraseq® FFPE NTRK RNA Fusion reference standard.5* In conclusion, anti-tropomyosin tyrosine kinase receptor drugs targeting NTRK genes have moved expeditiously from developmental stage all the way to the market. This has opened up new opportunities for cancer patients harboring these fusions to have access to therapeutic drugs that may ultimately address their diseases. To facilitate this, labs require highly-multiplexed FFPE NTRK RNA fusion reference standards for end-to-end evaluation of NGS assays from development to validation, and routine QC runs of patient samples. These reference standards provide readily available materials for rapid assay development and provide confidence to regulators and clinicians that an assay can detect the fusions pairs it claims to detect. --- **To learn how SeraCare generated an RNA panel representing decreasing levels of 16 different RNA fusions and exon-skipping events compared to the total cellular RNA, click below.** [**Assessing Sensitivity of NGS RNA Fusion Assays Using a Multiplexed and Well-Characterized Linearity Panel**](https://www.seracare.com/resources-and-education/scientific-posters/assessing-sensitivity-ngs-rna-fusion-assays/) **[![Download Poster Video](https://no-cache.hubspot.com/cta/default/20300467/9c3114d9-f26f-4ded-85db-ab7684291474.png)](https://cta-redirect.hubspot.com/cta/redirect/20300467/9c3114d9-f26f-4ded-85db-ab7684291474)** --- [\[1\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftnref1) [https://trkcancer.com](https://trkcancer.com) [\[2\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftnref2) [Ignyta Receives Orphan Drug Designation From FDA For Entrectinib For The Treatment Of Molecularly Defined Subsets Of Non-Small Cell Lung Cancer](https://www.thestreet.com/story/13035800/1/ignyta-receives-orphan-drug-designation-from-fda-for-entrectinib-for-the-treatment-of-molecularly-defined-subsets-of-non-small-cell-lung-cancer.html) [\[3\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftnref3) Discovered by Array BioPharma, licensed to [Loxo Oncology](https://ir.loxooncology.com/press-releases/2378241-Fda-approves-vitrakvi-larotrectinib-the-first-ever-trk-inhibitor-for-patients-with-advanced-solid-tumors-harboring-an-ntrk-gene-fusion12) for development, and Bayer as market launch partner. [\[4\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftnref4) [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626720.htm) [\[5\]](https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients#_ftnref5) [https://www.seracare.com/Seraseq-FFPE-NTRK-Fusion-RNA-Reference-Material-0710-1031/](https://www.seracare.com/Seraseq-FFPE-NTRK-Fusion-RNA-Reference-Material-0710-1031/) Topics: [NTRK](https://blog.seracare.com/ngs/tag/ntrk), [cancer](https://blog.seracare.com/ngs/tag/cancer), [RNA fusion](https://blog.seracare.com/ngs/tag/rna-fusion)     ### Subscribe Here!   [![New call-to-action](https://no-cache.hubspot.com/cta/default/20300467/538d26d7-6bf8-4208-9dad-6a783db06a0c.png)](https://cta-redirect.hubspot.com/cta/redirect/20300467/538d26d7-6bf8-4208-9dad-6a783db06a0c) ### Posts by Tag - [NGS (64)](https://blog.seracare.com/ngs/tag/ngs) - [reference materials (37)](https://blog.seracare.com/ngs/tag/reference-materials) - [clinical genomics (30)](https://blog.seracare.com/ngs/tag/clinical-genomics) - [ctDNA (29)](https://blog.seracare.com/ngs/tag/ctdna) - [cancer (24)](https://blog.seracare.com/ngs/tag/cancer) - [SeraSeq (16)](https://blog.seracare.com/ngs/tag/seraseq) - [cfDNA (14)](https://blog.seracare.com/ngs/tag/cfdna) - [NIPT (12)](https://blog.seracare.com/ngs/tag/nipt) - [RNA fusion (11)](https://blog.seracare.com/ngs/tag/rna-fusion) - [AACR (10)](https://blog.seracare.com/ngs/tag/aacr) - [AMP (10)](https://blog.seracare.com/ngs/tag/amp) - [liquid biopsy (10)](https://blog.seracare.com/ngs/tag/liquid-biopsy) - [FDA (7)](https://blog.seracare.com/ngs/tag/fda) - [ccfDNA (7)](https://blog.seracare.com/ngs/tag/ccfdna) - [LDT (6)](https://blog.seracare.com/ngs/tag/ldt) - [Assay Development (5)](https://blog.seracare.com/ngs/tag/assay-development) - [Reproductive Health (5)](https://blog.seracare.com/ngs/tag/reproductive-health) - [Accuplex (4)](https://blog.seracare.com/ngs/tag/accuplex) - [NTRK (4)](https://blog.seracare.com/ngs/tag/ntrk) - [Non-invasive Prenatal Testing (4)](https://blog.seracare.com/ngs/tag/non-invasive-prenatal-testing) - [QC Challenges (4)](https://blog.seracare.com/ngs/tag/qc-challenges) - [qc management (4)](https://blog.seracare.com/ngs/tag/qc-management) - [Lung Cancer (3)](https://blog.seracare.com/ngs/tag/lung-cancer) - [MRD (3)](https://blog.seracare.com/ngs/tag/mrd) - [New Reference Material (3)](https://blog.seracare.com/ngs/tag/new-reference-material) - [#Quality (2)](https://blog.seracare.com/ngs/tag/quality) - [EGFR (2)](https://blog.seracare.com/ngs/tag/egfr) - [Inherited Disease (2)](https://blog.seracare.com/ngs/tag/inherited-disease) - [Methylated DNA (2)](https://blog.seracare.com/ngs/tag/methylated-dna) - [Minimal Residual Disease (2)](https://blog.seracare.com/ngs/tag/minimal-residual-disease) - [Molecular Pathology (2)](https://blog.seracare.com/ngs/tag/molecular-pathology) - [PGT (2)](https://blog.seracare.com/ngs/tag/pgt) - [QC Management Software (2)](https://blog.seracare.com/ngs/tag/qc-management-software) - [TMB (2)](https://blog.seracare.com/ngs/tag/tmb) - [Women's health (2)](https://blog.seracare.com/ngs/tag/womens-health) - [myeloid cancer reference materials (2)](https://blog.seracare.com/ngs/tag/myeloid-cancer-reference-materials) - [ngs validation (2)](https://blog.seracare.com/ngs/tag/ngs-validation) - [trisomy (2)](https://blog.seracare.com/ngs/tag/trisomy) - [zika virus (2)](https://blog.seracare.com/ngs/tag/zika-virus) - [BioFidelity (1)](https://blog.seracare.com/ngs/tag/biofidelity) - [Breast Cancer (1)](https://blog.seracare.com/ngs/tag/breast-cancer) - [COVID-19 (1)](https://blog.seracare.com/ngs/tag/covid-19) - [Customer Testimonial (1)](https://blog.seracare.com/ngs/tag/customer-testimonial) - [Genomic Testing (1)](https://blog.seracare.com/ngs/tag/genomic-testing) - [HIV (1)](https://blog.seracare.com/ngs/tag/hiv) - [Immuno-Oncology (1)](https://blog.seracare.com/ngs/tag/immuno-oncology) - [PGS (1)](https://blog.seracare.com/ngs/tag/pgs) - [PGT-A (1)](https://blog.seracare.com/ngs/tag/pgt-a) - [Preimplantation genetic testing (1)](https://blog.seracare.com/ngs/tag/preimplantation-genetic-testing) - [QC Reporting (1)](https://blog.seracare.com/ngs/tag/qc-reporting) - [QC data management (1)](https://blog.seracare.com/ngs/tag/qc-data-management) - [Quality Management Systems (1)](https://blog.seracare.com/ngs/tag/quality-management-systems) - [SARS-CoV-2 (1)](https://blog.seracare.com/ngs/tag/sars-cov-2) - [bioinformatics (1)](https://blog.seracare.com/ngs/tag/bioinformatics) - [laboratory training (1)](https://blog.seracare.com/ngs/tag/laboratory-training) - [listeria (1)](https://blog.seracare.com/ngs/tag/listeria) - [methylated (1)](https://blog.seracare.com/ngs/tag/methylated) See all ### Recent Posts **About SeraCare** With over 30 years of experience as a leading partner to global in vitro diagnostics manufacturers and clinical testing laboratories, SeraCare’s clinical genomics technologies enable the promise of precision medicine by helping scientists and clinicians build and implement better clinical genomics assays. [Learn More](http://www.seracare.com/Company/WhoWeAre/tabid/335/Default.aspx)    - - - [Privacy Policy](http://www.seracare.com/PrivacyPolicy/tabid/211/Default.aspx)  |  [Legal Statement ](http://www.seracare.com/LegalStatement/tabid/212/Default.aspx) **Learn More** [Home](http://seracare.com/)  [About Us](http://seracare.com/Company/WhoWeAre/tabid/335/Default.aspx) [News and Events](http://www.seracare.com/NewsEvents/NewsCenter/tabid/354/Default.aspx)  [Blog](https://blog.seracare.com/)  [Contact](http://seracare.com/Contact/tabid/366/Default.aspx)  ![LGC+Marine-logo-FINAL-teal](https://blog.seracare.com/hs-fs/hubfs/1.%20Logos/LGC+Marine-logo-FINAL-teal.png?width=150&name=LGC+Marine-logo-FINAL-teal.png) 37 Birch Street Milford, MA 01757 [508-244-6400](tel:508-244-6400) l [800-676-1881](tel:800-676-1881) [info@seracare.com](mailto:info@seracare.com) ©2017 SeraCare Life Sciences, Inc. - [About SeraCare](http://www.seracare.com/Company/WhoWeAre/tabid/335/Default.aspx) - [Learn More](http://seracare.com/) - 37 Birch Street Milford, MA 01757 - Google Maps - 508-244-6400 - 508-634-3334 Fax - - - ![logo](https://blog.seracare.com/hubfs/logo.png "logo") 37 Birch Street Milford, MA 01757 508-244-6400 508-634-3334 Fax #### Products #### SeraCare #### Support & Resources - NGS & Digital PCR Tools - Controls & Reference Materials - Validation & Qualification Materials - Plasma & Serum Diluents & Derivatives - Cell Culture Reagents - KPL Antibodies & Conjugates - KPL Immunoassay Reagents & Kits - About Us - Careers - Press Releases - News Articles - Quality Systems - Terms & Conditions - Privacy Policy & Legal Statement - Register for an Account - Contact Us - Sign In - Resource Library - FAQs - Scientific Posters - White Papers - Videos ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Omo Clement, PhD", "url" : "https://blog.seracare.com/ngs/author/omo-clement-phd" }, "dateModified" : "2021-10-15T02:21:56.752Z", "datePublished" : "2019-02-06T05:00:00.000Z", "headline" : "NTRK Fusion Testing for New Therapies", "image" : [ "https://blog.seracare.com/hubfs/Imported_Blog_Media/NTRK_Cancer_Types.jpg" ], "mainEntityOfPage" : { "@id" : "https://blog.seracare.com/ngs/anti-tropomyosin-receptor-tyrosine-kinase-therapies-and-ntrk-fusion-testing-a-new-paradigm-for-identifying-and-managing-a-class-of-rare-pediatric-and-adult-cancer-patients", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://blog.seracare.com/hubfs/0.%20Logos/SeraCare/SeraCare.png" }, "name" : "LGC Clinical Diagnostics" } } ```