nCounter® FLEX Analysis System with Dx Enablement

Fully automated and easy-to-use, the nCounter® FLEX Analysis System with optional Dx enablement is a platform optimized for translational research. The nCounter FLEX’s Dx enablement package allows the system to be run in either Diagnostic and or Life Science mode depending on your needs. The nCounter® FLEX with Dx Enablement is the only approved platform capable of running the Prosigna® Breast Cancer Prognostic Gene Signature Assay.

  • Clinic-ready Platform: The Prosigna® Breast Cancer Prognostic Gene Signature Assay has received 510(k) clearance for use with the nCounter® FLEX Analysis System. nCounter® FLEX Analysis System is manufactured under GMP guidelines and ISO 13485 guidelines to ensure quality and compliance with international standards.
  • Translational Suite: nCounter® FLEX Analysis System 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.
  • 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 biomarker without the challenge of optimizing and maintaining components needed to support multiple RT-qPCR assays.
  • Simplify Analysis: No need for specialized Bioinformaticist. Results generated as direct counts and reported in a standard CSV file that can be imported into your favorite application or use the included nSolver Analysis Software for convenient data research analysis.
  • Expandable Throughput: Add a second Prep Station when needed and double your capacity to match a growing number of users. This configuration enables processing of up to 96 lanes per day and 384 samples with sample plexing. Random access enables users to pause data collection to load or remove additional cartridges without waiting for the run to finish.


Simple, User-Friendly Workflow with a sample to answer time of less than 24 hours when used in Life Sciences mode

Expand your throughput by adding a 2nd Prep Station to your nCounter® FLEX Analysis System


Feature

Specifications

Level of multiplexing

Up to 800 targets

Recommended amount of starting material (Dependent on assay and sample type)

RNA: 1 ng–50 ng

DNA: 5 ng–300 ng

Protein: 250 ng–2.5 µg

Sample types supported

Total RNA, cell lysates in GITC, FFPE-derived total RNA, and PAXgene-lysed whole blood

Reaction Volume

Up to 30 µl

Limit of detection 0.5 fM spike-in control

15 zeptomole spike-in control

Fold change sensitivity

> 1.5-fold (if > 5 copies per cell)

> 2-fold (if > 1 copy per cell)

Spike correlation

R² ≥ 0.95

Linear dynamic range

7 x 10⁵ total counts

Prep Station throughput

12 lanes per 2.5 hours

Digital Analyzer throughput*

12 samples per 2.7 hours

Controls

Assay dependent

Feature

Specifications

Operating temperature

18–28°C

Humidity

30-80% (non-condensing)

Pollution degree

2

Power source

100–240 VAC, 50–60 Hz

Power draw

610 VA

Dimensions (Prep Station)

67 x 89 x 63 cm

Dimensions (Digital Analyzer)

66 x 66 x 48 cm

Click here to view publications.

Product

Description

Catalog Number

Unit Size

nCounter® FLEX Analysis System

Includes the Prep Station and the Digital Analyzer with the FLEX Configuration

NCT-SYST-FLEX

100511

Dx Enablement Package for Flex

Includes IQ/OQ/PQ and training for up to 6 operators, plus Prosigna Starter Kit of 70 tests.

NCT-FLEX-Dx ENBL

100514

nCounter® Prep Station

Automated fluidic handler for processing assays

NCT-PREP-LS

100520

nCounter® Digital Analyzer

Automated instrument for data collection

NCT-DIGA-LS

100519

nCounter® System Quick Tour
nCounter® Technology
nCounter® and Cancer Research
FFPE Samples with the nCounter® Analysis
Prosigna provides a highly precise method for measuring breast cancer genomic signatures from formalin-fixed paraffin-embedded (FFPE) tissue

nCounter Dx Analysis System with FLEX configuration is available for in vitro diagnostic use when used in conjunction with cleared or approved assays, such as the Prosigna Assay.
nCounter FLEX Analysis System without Dx enablement is for Research Use Only. Not for use in diagnostic procedures.
nSolver Analysis Software is for Research Use Only. Not for use in diagnostic procedures.