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Prosigna Breast Cancer Prognostic Gene Signature Assay

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K141771

by Nanostring Technologies

Identity

Trade Name
Prosigna Breast Cancer Prognostic Gene Signature Assay FDA UDI
Generic Name
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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. FDA UDI
Model / Reference
PROSIGNA-001 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
PROSIGNA-001 FDA UDI
Primary DI / UDI-DI
00859812006010 FDA UDI
FDA Product Code
NYI FDA UDI
GMDN Term
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Prosigna Breast Cancer Prognostic Gene Signature Assay by Nanostring Technologies — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)

Similar devices

Also classified as Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanostring Technologies
FDA Applicant
Nanostring Technologies, Inc.

Sources (2)

  • FDA UDI 602f52c9-7213-4f65-815d-2ff8fb2a5971 59 fields · synced Jun 18, 2026
  • FDA 510(k) K141771 1 fields · synced May 29, 2026