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nCounter Flex
nCounter Dx with FLEX
















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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
  • Software
  • Specifications

Supported Applications

Application Description
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) + - -
RUO - + +
For Laboratory Use - - +
Pre-configured panels* + + -
Custom assays - + -
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

nCounter Master Kit

Contains all necessary reagents. Requires sample and nCounter CodeSet. Learn more about the Master Kit Contents.

Included Software

For Operation
Web App GUI Web Application:
- Supports the Prosigna Breast Cancer Prognostic Gene Signature Assay
- Set up runs and access data from your desktop.
Control Panel GUI 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*

Description Specification
Multiplexing capacity Up to 800 targets
Recommended amount of starting material RNA:
- 50 ng (using high sensitivity protocol)
DNA:
- 300 ng
RNA:Protein:
- 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
Controls Assay dependent

*Does not apply to Prosigna Breast Cancer Prognostic Gene Signature Assay.

Optional settings may require less processing time with reduced sensitivity.

Hardware Specifications

Dx Prep Station Dx Digital Analyzer
Prep Station Digital Analyzer
Operating Temperature 18-28°C 18-28°C
Humidity 20 - 80% (non-condensing) 20 - 80% (non-condensing)
Pollution degree 2 2
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

Request Information | E-mail us: info@nanostring.com | Call us: 1 888 358 6266