Comprehensive digital PCR (dPCR)-based solution for the quantitative, highly sensitive and low-cost monitoring of genetic mutations and fusions in haematological malignancies, designed for the continuous monitoring of previously identified molecular targets. RainSure offers an extensive catalogue of tests for the individual detection of up to 46 fusions and 121 hotspots.
Detailed Description
The proposed workflow is based on the concept: “identify the target and track it”. Once the patient’s complete molecular profile has been obtained at the time of diagnosis (for example, through high-throughput sequencing or NGS), the identified molecular targets are monitored over time using RainSure dPCR technology (from DNA or RNA, depending on the target of interest). dPCR precisely and repeatedly measures the amount of mutation or fusion gene that remains present at each patient follow-up visit.
Clinical Applications
It is intended for the detection and monitoring of minimal residual disease (MRD) and the follow-up of haematological malignancies over time, assessing treatment response, the maintenance of remission and the detection of possible relapses or resistance by analysing the temporal evolution of the mutational or fusion burden.
Benefits
Technology Used
The RainSure RS-32 system uses RainSure’s patented droplet digital PCR (droplet dPCR) technology. This system automates the entire process, from droplet generation to amplification and signal detection, and features a closed workflow that reduces the risk of contamination while reducing manual intervention and processing times.
Considerations or Limitations
Assay sensitivity is not a single instrument specification, but depends on the target being studied, the number of copies present, sample quality and the workflow.
Key Features
Presentation Details
| Product | Marking | Format | Contents |
|---|---|---|---|
| Hematology fusion-gene dPCR assays (RUO)* | RUO | 12 rxn | Individual kits for studying up to 46 different fusion genes. |
| Hematology mutation dPCR assays (RUO)* | RUO | 12 rxn | Individual kits for studying up to 121 different hotspot mutations, distributed across 43 genes. |
| BCR ABL p210/p190 digital PCR one-tube quant test (CE-IVD) | CE-IVD | 24 rxn | Quantification of the two main fusion transcripts in a single assay. 24-test format. |
| Human JAK2 Gene V617F Mutation Detection Kit (CE-IVD) | CE-IVD | 96 rxn | Quantification of the V617F mutation in the JAK2 gene |
