Archer™ IVD FUSIONPlex™ Dx Assay Solutions
Diagnostic-ready NGS library preparation for DNA inputs
We enable labs to choose easy-to-implement technologies that best serve their diagnostic needs.
Our Archer IVD Assay portfolio for EU and US customers is built on our trusted, easy-to-use Anchored Multiplex PCR technology. Over time, this portfolio will expand to include advanced NGS capabilities, such as novel fusion and complex variant detection for challenging sample types.
Accelerate precision medicine from discovery to diagnostics.
Ordering
- FUSIONPlex™-HT Dx is a set of reagents and consumables used to prepare sample libraries, using manual and automated methods, from Nucleic Acid (RNA or TNA) extracted from fresh frozen or formalin-fixed, paraffin-embedded (FFPE) tissue or cells. User-supplied oligonucleotide panels are required for the preparation of libraries targeting specific genomic regions of interest.
- Registered with the FDA and IVDR compliant.
- Designed for an optimal user experience, featuring color-coded, technician- and robot-friendly reagents, fast workflows (1–1.5 days TAT, 3.5 hours hands-on time), and expert support for implementation and sustainment.
- Based on the Archer platform technology including our patented Anchored Multiplex PCR chemistry to empower molecular pathology laboratories with the right diagnostic products.
Each FUSIONPlex™-HT Dx kit contains an Archer™ Liquid Adapter Dx Kit (Set A or B ordered separately) orderable in both 24 & 96 reaction formats. All formats include FUSIONPlex™-HT Dx Liquid Reagents, Archer™ Cleanup Reagents, and the associated instructions for use.
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| FUSIONPlex-HT Dx | VARIANTPlex-HT Dx | |
|---|---|---|
| Use | Diagnostic targeted RNA sequencing workflows | Diagnostic targeted DNA sequencing workflows |
| Application Area | Solid tumor and heme oncology methods | Solid tumor and heme oncology methods |
| Sample Input | Nucleic acid (RNA or TNA) extracted from fresh-frozen or formalin-fixed, paraffin-embedded tissue or cells | Nucleic acid (DNA or TNA) extracted from fresh-frozen or formalin-fixed, paraffin-embedded tissue or cells |
| Reaction formats | 24- or 96-reaction liquid reagents | 24- or 96-reaction liquid reagents |
| Automation | Compatible with manual and automated library preparation methods | Compatible with manual and automated library preparation methods |
| Kit includes |
Adapters and indexing primers
Enzymes and buffers Magnetic bead-based cleanup reagents |
Adapters and indexing primers
Enzymes and buffers Magnetic bead-based cleanup reagents |
| Order now | Order now |
Easier, more consistent benchtop work
Each kit includes color coded, technician and robot-friendly adapters, indexing primers, enzymes, buffers, and magnetic bead-based cleanup reagents. The workflow is consistent across formats, enabling efficient and reproducible library preparation.
Figure 1. Reagents are color-matched to protocol steps for easy benchwork. Each step of the protocol has a different color, which matches the packaging of the reagents (in this case liquid reagents) for that step.
High- throughput automation-ready for scalable workflows
96-reaction formats and standardized reagents offer compatibility and consistency with automated library preparation workflows. Liquid adapters are available in a 96-well plate format and feature over 36,000 unique dual index combinations to support high-throughput sequencing.
Sample input versatility and uniformity
The workflow accommodates both fresh-frozen and FFPE sample types, maintaining consistent incubation and cycling conditions across formats. This uniformity enhances reproducibility, streamlines training, and simplifies onboarding, which help lab personnel uphold high-quality standards with confidence.
Product data
Summary of Performance Characteristics
Library yield of 4nM or greater is expected when input masses are from 10-200ng. The table below summarizes the performance results for library yield of FUSIONPlex™-HT. All results pass the acceptance criteria.
| Primer Panel | Input Description (Manufacturer and part number) | Input mass (ng) | Replicates | Result (Pass criteria ³ 90% OPA) |
|---|---|---|---|---|
| Gene Specific Primer Oligonucleotide Pool 1 | qPCR Human Reference Total RNA (Takara Bio. 636690) | 10 | 3 | Pass |
| 50 | 3 | |||
| 200 | 3 | |||
| Mimix™ Pan-Cancer 6-Fusion Panel (Horizon Discovery HD834) | 10 | 3 | ||
| 50 | 3 | |||
| 200 | 3 | |||
| Water (Sigma-Aldrich W4502-50ML) | 0 | 5 | Pass | |
| Gene Specific Primer Oligonucleotide Pool 2 | qPCR Human Reference Total RNA (Takara Bio. 636690) | 10 | 3 | Pass |
| 50 | 3 | |||
| 200 | 3 | |||
| Mimix™ Pan-Cancer 6-Fusion Panel (Horizon Discovery HD834) | 10 | 3 | ||
| 50 | 3 | |||
| 200 | 3 | |||
| Water (Sigma-Aldrich W4502-50ML) | 0 | 5 | Pass |
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Frequently asked questions
What is Anchored Multiplex PCR (AMP™)?
Anchored Multiplex PCR (AMP™) is a targeted next-generation sequencing (NGS) library preparation method designed to detect genomic alterations in challenging sample types, including highly degraded input materials like FFPE. AMP uses multiple “anchored” gene-specific primers (GSPs) that amplify opposite a single universal primer. This open-ended, anchored amplification makes AMP highly effective for discovering simple, novel, and complex rearrangements
Is FUSIONPlex™-HT Dx compatible with automated liquid handling robots?
Yes. FUSIONPlex-HT Dx reagents are compatible with both manual and automated library preparation methods.
What are the benefits of using TNA input for RNA-based library preparation?
Using TNA input for RNA-based library preparation simplifies laboratory workflows by enabling labs to leverage a single nucleic acid extraction method to generate input material for multiple downstream molecular workflows.
How does the VARIANTPlex-HT Dx workflow compare to the FUSIONPlex-HT Dx workflow?
Following DNA Fragmentation for VARIANTPlex-HT Dx and cDNA generation for FUSIONPlex-HT Dx, the workflow steps required to create sample libraries are the same for both products.
What sequencing platforms is FUSIONPlex-HT Dx compatible with?
FUSIONPlex-HT Dx and VARIANTPlex-HT Dx libraries work with sequencing platforms that leverage P5 and P7 sequences to confer sequencer compatibility.
Related products
Products intended for in vitro diagnostic use and conforming to In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)
IVD25-4088_001