In the era of precision medicine, next-generation sequencing (NGS) has become a vital tool for comprehensive genomic profiling (CGP) of solid tumors. However, with a broad spectrum of therapies already approved or in clinical trials, it is essential to develop rapid and scalable techniques capable of detecting an evolving number of therapeutically relevant genomic alterations and complex biomarkers.To meet these needs, OncoDNA, a world-leading theranostics company, developed OncoDEEP — an all-in-one CE-IVD approved assay supporting the delivery of personalized treatment strategies. Curated by oncology experts and powered by Twist hybrid capture technology, the OncoDEEP NGS panel delivers accurate profiling of single-nucleotide variants (SNVs), copy number variants (CNVs) and insertions and deletions (indels) in 638 clinically relevant genes.

The Twist Precision Dx Products are a suite of approved regulated solutions that support sequencing workflows for clinical applications. The Twist Precision Dx Products include a highly sensitive nucleic acid library preparation and enzymatic fragmentation kit used for the preparation of sequencing libraries from high-quality genomic DNA isolated from human cells, such as whole blood. The Twist Precision Dx Products utilize Twist Bioscience’s robust target capture system to produce target-enriched libraries compatible with Illumina sequencing instrumentation. This document provides the labeling and workflow information for the following products: Twist Precision Prep and Enrichment Dx Kit - The Twist Precision Prep and Enrichment Dx Kit is a reagent kit including enzymatic fragmentation, library preparation, and targeted capture. The kit is intended for use with high-quality genomic DNA derived from human cells in the preparation of libraries for Next-Generation Sequencing (NGS) applications. The kit can be used to target specific regions of the genome with DNA panels supplied by users or with a qualified Twist DNA panel (such as the Twist Precision Exome Dx Panel) for Next-Generation Sequencing (NGS) applications.   Twist Precision Exome Dx Panel - The Twist Precision Exome Dx Panel is a qualified Twist DNA panel used in conjunction with the Twist Prep and Enrichment Dx Kit to produce exome-enriched libraries compatible for Next Generation Sequencing applications.   Twist Precision Exome Dx Kit - Twist Precision Exome Dx Kit is a reagent kit including enzymatic fragmentation, library preparation, and targeted capture with the included Twist Precision Exome Dx panel. The kit is intended for use with high-quality genomic DNA derived from human cells. The kit utilizes the qualified Twist Precision Exome Dx Panel with the Twist Precision Prep and Enrichment Dx Kit to produce exome-enriched libraries compatible for Next-Generation Sequencing (NGS) applications.