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Oncology & Haematology · MSI
Healthincode Distributed by Goffin Diagnostics

Action Oncology KitDx (Automatic)

Action Oncology KitDx is a next-generation sequencing panel for solid tumours. It covers 55 genes including hotspot regions and fusion genes, contains a 110-microsatellite panel for microsatellite instability testing, detects copy number variations including 1p/19q and 1q/16p, and analyses 20 genes for pharmacogenetics. One kit covers 24 reactions. CE marked for in vitro diagnostic use.

NGS CE-IVD Healthincode 1 Unit (24 Reactions)
Technique
NGS
Brand
Healthincode
Packaging
1 Unit (24 Reactions)
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Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.

Product details

This kit in detail

  • 55-gene panel with hotspot regions and fusion genes
  • 110-microsatellite panel for microsatellite instability testing
  • Copy number variations including 1p/19q and 1q/16p, validated by a low-density SNP array
  • 20 genes analysed for pharmacogenetics
  • Molecular barcoding to remove PCR duplicates from the analysis
  • 50 to 200 ng of DNA from peripheral blood or tissue
  • 24 reactions per kit, with 24 unique 8-nucleotide indexes

Action Oncology KitDx characterises solid tumours by next-generation sequencing, covering sequence variants, microsatellite instability, copy number variations and pharmacogenetics in one workflow.

Panel content

The panel covers 55 genes, together with hotspot regions and fusion genes.

Microsatellite instability

A 110-microsatellite panel is included for microsatellite instability testing, which is used in diagnosis and prognosis.

Copy number variations

The panel detects copy number variations, including combined alterations such as 1p/19q and 1q/16p. A low-density SNP array is used to validate these results.

Pharmacogenetics

Twenty genes are analysed for pharmacogenetic variants, which provide a basis for dose adjustment in chemotherapy.

Sensitivity

Molecular barcoding is applied during library preparation, so PCR duplicates can be removed during bioinformatic analysis.

Sample and input

The assay runs on DNA from peripheral blood or from tissue, and requires 50 to 200 ng of DNA.

Workflow

Library preparation uses Illumina adapters. The kit supplies 24 unique 8-nucleotide indexes in single-use strips, so 24 samples can be identified within one sequencing run.

Quality and regulatory status

The manufacturer, Health in Code, is certified against UNE-EN ISO 13485:2018 for quality management. This kit is CE marked for in vitro diagnostic use.

The kit contains the necessary reagents to perform 24 reactions. The reagents included in the kit are the following:

  • Fragmentation Buffer: Buffer used for DNA fragmentation, prior to NGS libraries preparation.
  • Fragmentation Enzyme: Enzyme used for DNA fragmentation, prior to NGS libraries preparation.
  • Reagents Plate: Plate with all the reagents required to perform the DNA end repair, the Illumina adapters linkage, and amplifications done during the library preparation protocol.
  • Beads and Buffers plate: Plate with magnetic particles and wash buffers, required for the DNA capture and its purification during the library preparation protocol.
  • Index: Oligonucleotides with a unique 8 nucleotides identifier sequence compatible with the illumina adapters required to identify each sample during library preparation and NGS sequencing.
    The kit includes 24 different indexes, prepared in single-use strips.
  • Hematology Probes Strips: Biotinylated synthetic oligonucleotides complementary to the target regions of the target genes.
  • Elution Buffer: Buffer used to elute the DNA.
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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