Prosigna Breast Cancer Prognostic Gene Signature Assay PROSIGNA-004

GUDID 00859812006041

Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hybridization, visualization and image analysis system based upon coded probes designed to detect the messenger RNA transcribed from 58 genes. The test input is purified RNA from FFPE breast tumor specimens which are acquired from surgical resection. The Prosigna assay uses gene-specific probe pairs that hybridize directly to the mRNA transcripts in solution. The nCounter Dx Analysis System delivers direct, multiplexed measurements of gene expression through digital readouts of the relative abundance of the mRNA transcripts. Prosigna simultaneously measures the expression levels of 50 genes used in the PAM50 classification algorithm (Parker et al., 2009), 8 housekeeping genes used for signal normalization, 6 positive controls, and 8 negative controls in a single hybridization reaction, using nucleic acid probes designed specifically to those genes. The software algorithm produces a Prosigna Score (referred to as ROR Score or Risk of Recurrence Score in the literature (Dowsett et al., 2013)) based on the similarity of the expression profile to each PAM50 molecular subtype, as well as the gross pathological tumor size and a proliferation score computed from a subset of genes. Three risk categories (Low, Intermediate and High) were defined based on a study with over 1007 patient samples associating Prosigna score with long-term outcome. The required components for the Prosigna Assay include the RNA Isolation kit (manufactured by Roche), Prosigna reagents (Reference Sample, CodeSet, Prep Pack, Cartridge(s) and Prep Plate) and the instruments that comprise the nCounter Dx Analysis System; the Prep Station and Digital Analyzer. The test output is a patient specific report which includes a Prosigna Score (0-100) and risk category (low/intermediate/high) where indicated.

NANOSTRING TECHNOLOGIES, INC.

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Primary Device ID00859812006041
NIH Device Record Key10702be3-06ad-45ea-b418-5e177da9c05e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsigna Breast Cancer Prognostic Gene Signature Assay
Version Model NumberPROSIGNA-004
Catalog NumberPROSIGNA-004
Company DUNS143888712
Company NameNANOSTRING TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com
Phone1 888-358-6266
Emailinfo@nanostring.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859812006041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NYIClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-06
Device Publish Date2016-09-20

On-Brand Devices [Prosigna Breast Cancer Prognostic Gene Signature Assay]

00859812006058Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analys
00859812006041Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analys
00859812006034Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analys
00859812006027Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analys
00859812006010Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analys
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