Customized Assays Assembled Using Digital Molecular Barcoding Chemistry

(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