TRANSLATIONAL MEDICINE — Moving from NGS results to Gene Signature
Converting insights from data-dense, next-gen sequencing and expression profiling approaches into “clinical-strength” multi-gene assays remains a challenge. Distinctive technologies developed by Seattle, WA-based NanoString Technologies (founded in 2003) which provide simple, automated, digital profiling of single molecules will be described. The methodology is based on an optical digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) under the direction of Dr. Leroy Hood (Nature Biotech (2008) 26:317-25).
Using NanoString technology, up to 800 distinct nucleic-acid targets can be digitally counted in samples that range from single cells (10 pg input RNA) to 30-yr-old formalin-fixed, paraffin-embedded tumor specimens.
NanoString recently introduced a new chemistry called “nCounter Elements™” that allows individual labs to create their own custom codesets using ordinary oligonucleotides (purchasable from any oligo-vendor). NanoString optical-barcode reagents (sold as a General Purpose Reagent) interact with 3rd party sourced generic oligonucleotides and allow individual labs to quickly design and implement their own assays that can be utilized for research purposes or for Laboratory Developed Tests.
NanoString recently received a CE Mark for its breast cancer gene expression test, allowing NanoString to offer the test on its nCounter system in the European Union and other countries that recognize the CE Mark. Nanostring has just received FDA 510(k) Clearance for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Additional research areas in biology (single-cell, miRNA, CNV, gene-fusions, plant studies, non-human studies) and clinical opportunities in medicine (prognostic and predictive genomics) will be explored during the presentation.
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