nCounter® Dx Analysis System with FLEX
For Clinical Applications
Flexible platform used to translate oncology signatures from research to the clinic.
Clinic-ready Platform: The Prosigna® Breast Cancer Prognostic Gene Signature Assay has received 510(k) clearance for use with the nCounter Dx Analysis System with FLEX configuration. nCounter FLEX is manufactured under GMP guidelines and ISO 13485 guidelines to ensure quality and compliance with international standards.
Translational Suite: nCounter FLEX can operate in two distinct modes: Diagnostics and Life Sciences. In addition, an enterprise software package is included to control user access, automate data flow, and generate audit logs.
Tumor Analysis: Analyze gene expression without a cDNA synthesis step, enabling greater tolerance of RNA degradation and inhibitors associated with the formalin fixation process. Improve confidence when analyzing FFPE tissue such as tumors that can be matched to known patient outcomes.
Develop Tailored Signatures: Reduce large gene sets (up to 800 targets) with a single nCounter CodeSet and single-tube multiplexing technology. Quickly reach a focused gene signature that can be translated into a robust clinical biomarker without the challenge of optimizing and maintaining components needed to support multiple RT-qPCR assays.
nCounter® Dx Analysis System with FLEX Configuration
- Supported Applications
- Compatible Chemistries
|RNA:Protein||Perform multianalyte measurement of both RNA and proteins simultaneously.|
|mRNA||Automated RNA profiling without cDNA synthesis, library prep, or amplification.|
|miRNA||Specific measurements of microRNA transcriptomes from human, mouse, and rat.|
|CNV||Highly accurate and reproducible detection of gene copy number variation.|
|Fusion Genes||Find breakpoint locations and specific junction sequences.|
Compatible Barcode Chemistries
|For Breast Cancer Prognosis||For Pathway Analysis||For Lab Tests|
|Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50 based)||nCounter CodeSets||nCounter Elements|
|510(k) Clearance (IVD)||+||-||-|
|For Laboratory Use||-||-||+|
|Targets per sample||50||20 - 800||1 - 216|
|Samples per lane||1||Up to 4||1|
|Total samples per run||10||Up to 48||12|
*Assay comes with gene-specific probes and/or epitope-specific antibodies.
Core Consumables Kit
Contains all necessary reagents. Requires sample and nCounter CodeSet. Learn more about the Master Kit Contents.
- Supports the Prosigna Breast Cancer Prognostic Gene Signature Assay
- Set up runs and access data from your desktop.
|Instrument Control Panel:
- Supports the Prosigna Breast Cancer Prognostic Gene Signature Assay (IVD Mode)
- Supports Life Sciences research applications (Life Sciences mode, For Research Use Only)
|For Design||For Analysis|
|nDesign™ Gateway||nSolver™ Analysis Software|
|Create custom CodeSets.||Automated QC, normalization, and analysis of nCounter data.|
Platform Performance Specifications*
|Multiplexing capacity||Up to 800 targets|
|Recommended amount of starting material||RNA:
- 50 ng (using high sensitivity protocol)
- 300 ng
- 400-5,000 cell equivalent lysates
|Supported sample types||Total RNA, cell lysates in GITC, FFPE-derived total RNA, and PAXgene-lysed whole blood|
|Reaction volume||Up to 30 μL|
|Detection limit||15 zeptomole spike-in control|
|Fold change sensitivity||> 1.5-fold (if > 5 copies per cell)
> 2-fold change (if > 1 copy per cell)
|Spike correlation||R² ≥ 0.95|
|Linear dynamic range||7 x 10⁵ total counts|
|Prep Station throughput†||12 samples per 2.5 hours|
|Digital Analyzer throughput†||12 samples per 2.7 hours|
*Does not apply to Prosigna Breast Cancer Prognostic Gene Signature Assay.
† Optional settings may require less processing time with reduced sensitivity.
|Dx Prep Station||Dx Digital Analyzer|
|Humidity||20 - 80% (non-condensing)||20 - 80% (non-condensing)|
|Power source||100-240 VAC, 50-60 Hz||100-240 VAC, 50-60 Hz|
|Power draw||610 VA||610 VA|
|Dimensions||67 x 89 x 63 cm||66 x 66 x 48 cm|