We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App


ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.
24 Jan 2022 - 27 Jan 2022

Customized Assays Assembled Using Digital Molecular Barcoding Chemistry

By LabMedica International staff writers
Posted on 31 Jul 2013
Print article
A line of General Purpose Reagents (GPRs) was developed specifically to meet the needs of translational research and clinical laboratories.

NanoString Technologies, Inc. (Seattle, WA, USA), a provider of life science tools for translational research and molecular diagnostic products, announced an Early Access Program for nCounter Elements, a line of General Purpose Reagents (GPRs). The announcement was made at the annual meeting of the American Association for Clinical Chemistry (AACC) taking place in Houston (TX, USA) from July 28—August 1, 2013.

nCounter Elements GPRs enable researchers to independently develop multiplexed genomic assays, and then rapidly translate those assays into clinical diagnostics offered as laboratory developed tests.

A digital molecular barcoding chemistry, nCounter Elements allows users to assemble their own customized assays using standard sets of barcodes provided by NanoString and probes that they can purchase independently from an oligonucleotide manufacturer.

"This launch further supports NanoString's vision of helping researchers to advance their understanding of disease, and then directly apply that knowledge to molecular diagnostics," said Brad Gray, president and CEO of NanoString Technologies. "By opening our technology to laboratories developing innovative diagnostics, we can accelerate the growth of our business in clinical laboratories and reach even more patients than we could through the development of in vitro diagnostic products alone."

The nCounter Elements reagents have been registered with the US Food and Drug Administration (FDA; Silver Spring, MD, USA) as a General Purpose Reagent, and are available for use in developing Laboratory Developed Tests, pursuant to a licensing arrangement to be offered by NanoString. In addition, the highly flexible architecture of nCounter Elements enables a broad range of basic research studies where iterative design and refinement of assays are important.

Since the completion of the sequencing of the human genome, many clinically relevant biomarkers and signatures have been identified. However, it has not always been possible to validate highly multiplexed assays that can both reliably test clinical samples, such as tissue biopsies stored as Formalin-Fixed Paraffin Embedded (FFPE) samples, and be easily implemented in a clinical laboratory. With nCounter Elements GPRs, this has become possible.

The nCounter-based Prosigna Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic kit to be marketed through the company's diagnostics business. It has received the CE marking and it is available for use by healthcare professionals in the European Union and other countries that recognize the CE marking, and in which Prosigna is registered; it is pending 510(k) clearance with the FDA and is not yet available for sale in the United States.

Related Links:
NanoString Technologies, Inc.
Food and Drug Administration

Gold Supplier
Fluorimetric Immunoassay Analyzer
Confiscope F20
Progesterone ELISA Test
17-Alpha Hydroxy Progesterone ELISA
Multi-Tube Vortexer
BenchMixer XL
Automated Hematology Analyzer
Mispa Count Plus

Print article
IIR Middle East


Molecular Diagnostics

view channel
Image: The SMARTer Stranded Total RNA-Seq Kit v2 - Pico Input Mammalian is used to generate strand-specific RNA-seq libraries (Photo courtesy of Takara Bio)

Cell-free RNA Profiles Gauge Preeclampsia Risk Months Before Symptoms

The period from conception to delivery represents the most rapid growth and development in an individual’s life. The ability to support this development requires dramatic and inadequately understood alterations... Read more


view channel
Image: QX200 AutoDG ddPCR System and QXDx BCR-ABL %IS Kit (Photo courtesy of Bio-Rad)

ddPCR Developed for BCR-ABL1 Fusion Transcript in B-Lymphoblastic Leukemia

Droplet digital polymerase chain reaction (ddPCR) is a novel polymerase chain reaction (PCR) technique reliant on massive sample partitioning to generate individual reaction chambers (droplets) in which... Read more


view channel

Global Coagulation Analyzers Market Driven by Growing Awareness About Timely Diagnosis of Blood Clots

The global coagulation analyzers market is expected to reach USD 11.7 billion by 2028, driven by the increasing understanding of blood clots and the fact that they can be avoided with early detection.... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.