Roche Tissue Diagnostics
Tucson, November 27, 2018
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the global launch of the VENTANA pan-TRK (EPR17341) Assay, the first automated in vitro diagnostic (IVD) immunohistochemistry (IHC) assay to detect tropomyosin receptor kinase (TRK) proteins in cancer.
With the launch, laboratories are now able to identify wild-type and chimeric fusion proteins through detection of the TRK C-terminal region. This assay can be used to perform analytic studies, including prevalence in solid tumors.
While wild-type protein expression is generally low in both prevalence and intensity level, it can be substantial in some neuroendocrine tumor tissues. TRK-fusion proteins have been identified in a wide range of commonly occurring tumors, including lung, thyroid and sarcoma, at a low frequency.2-8 In some rare tumors, including infantile fibrosarcoma, secretory and juvenile breast cancer and mammary analogue secretory cancers of the salivary glands, TRK fusion proteins are likely to be the defining genetic feature.9-13
The VENTANA pan-TRK (EPR17341) Assay is available for use on Roche’s BenchMark series of IHC/ISH automated staining instruments.
The VENTANA pan-TRK (EPR17341) CE IVD/US Class I Assay is designed to detect C-terminal protein expression, which allows for the detection of TRK-fusion as well as wild-type protein expression. The epitope detected by the antibody is encoded downstream of the tyrosine kinase domain within the 3 prime coding region of the neurotrophic tyrosine receptor kinase (NTRK) 1, 2 and 3 genes and is conserved across all three TRK proteins, A, B and C.
NTRK genes are oncogenes that can be activated and drive cancer progression when chromosomal rearrangements lead to their juxtaposition with other genes, including ETV6, EML4, LMNA and TPM3. The resulting TRK-fusion proteins can drive overexpression and constitutive activation of the TRK tyrosine kinase, leading to aberrant signaling through downstream pathways. NTRK gene fusions are currently being explored in clinical trials for several targeted cancer therapies.
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
VENTANA and BenchMark are trademarks of Roche. Other product names and trademarks are the property of their respective owners.
1. This product is intended for in vitro diagnostic (IVD) use
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15. OncomineTM Focus Assay, Part I: Library Preparation USER GUIDE. Document number: MAN0015819.B.0.
16. OncomineTM Focus Assay Part II: Plan a Run, Template Preparation, and Sequencing USER GUIDE. Document number. MAN0015820.A.0.
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Roche Tissue Diagnostics
Protein expression in mammary analogue secretory carcinoma with TRK fusion stained with VENTANA pan-TRK (EPR17341) Assay (20x)*
*Fusion status based upon next generation sequencing reported from external laboratory developed test using Oncomine™ Focus Assay®14-17
Protein expression in head and neck squamous cell carcinoma with wild-type TRK stained with VENTANA pan-TRK (EPR17341) Assay (20x)