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 hp
Sign In
Advertise with Us

Download Mobile App





Customized Assays Assembled Using Digital Molecular Barcoding Chemistry

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

NanoString Technologies, Inc. More...
(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 Member
Immunochromatographic Assay
CRYPTO Cassette
Collection and Transport System
PurSafe Plus®
New
Gold Member
Collection and Transport System
PurSafe Plus®
Autoimmune Liver Diseases Assay
Microblot-Array Liver Profile Kit
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The CloneSeq-SV approach can allow researchers to study how cells within high-grade serous ovarian cancer change over time (Photo courtesy of MSK)

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Industry

view channel
Image: Private equity firms Blackstone and TPG have joined forces to acquire Hologic in a major healthcare deal (Photo courtesy of Hologic)

Hologic to be Acquired by Blackstone and TPG

Hologic (Marlborough, MA, USA) has entered into a definitive agreement to be acquired by funds managed by Blackstone (New York, NY, USA) and TPG (San Francisco, CA, USA) in a transaction valued at up to... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.