HTG EdgeSeq ALKPlus Assay EU

 HTG’s New Sequencing-based Assay for Detecting ALK Status Plus More

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic, next-generation sequencing (NGS)-based assay intended to measure and analyze mRNA ALK gene fusion events in formalin-fixed, paraffin-embedded (FFPE) lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC). The HTG EdgeSeq ALKPlus Assay EU is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib).

HTG EdgeSeq PATH Assay

The HTG EdgeSeq PATH Assay (previously referred to as project Mercury) has been designed for retrospective gene expression profiling to complement traditional immunohistochemistry (IHC) testing by allowing investigators to assess mRNA expression of large numbers of biomarkers when formalin-fixed, paraffin-embedded (FFPE) sample availability is limited. The assay is designed to detect up to 470 mRNA targets, typically assessed by IHC.

HTG EdgeSeq miRNA Whole Transcriptome Assay 

The HTG EdgeSeq miRNA Whole Transcriptome Assay enables users to measure the expression of 2,083 human miRNA transcripts using next-generation sequencing. The HTG EdgeSeq extraction-free sample preparation chemistry is compatible with fixed tissue samples, biofluids, cell lines, and extracted RNA. The assay is powered by HTG's proprietary quantitative nuclease protection and is automated on the HTG EdgeSeq system.

HTG EdgeSeq Oncology Biomarker Panel 

Profile tumor samples in order to identify therapeutic targets and drug response markers using an NGS-based gene expression assay powered by the HTG EdgeSeq chemistry.  

Thousands of genes (2,560), 24 groups and pathways

Commercialization and Global Distribution

HTG has built a global network to support both the clinical trial requirements and the global commercialization requirements.

Certified Service Providers
Certified Service Provider’s are a network of regional and national and international CRO’s that have Edge instrumentation and are certified by HTG for specific assays.  These laboratories can be used to run retrospective studies and can also be used for prospective registration trials.

<link to list of CSP's>

Biomarker Validation

The HTG Edge system enables a seamless transition from early clinical research where biomarker discovery may have been done in cell or animal models to translational medicine and clinical development where the preferred sample type is formalin-fixed, paraffin embedded (FFPE) tissue.  

Companion Diagnostics

HTG Molecular can help drug development teams build a deployable oncology biomarker strategy for their drug. The major elements are:

An Experienced Team of Diagnostic Experts

The leadership team at HTG has over 200 years of diagnostic experience and has successfully developed and commercialized companion diagnostics for HER2 and c-Kit.



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