NanoString Technologies wowed markets this week with Monday’s news that their Prosigna™ Breast Cancer Assay platform received 510(k) clearance from the FDA. An automated and easy to use molecular diagnostics platform based on the company’s proven gene expression technology nCounter®, which has helped see over 100 peer-reviewed studies come to publication since 2008, Prosigna is now able to be placed in qualified labs all over the country.
The company has taken their proven nCounter Dx Analysis System and structured a platform around the PAM50 gene signature, resulting in an in vitro diagnostic assay that is fully self-contained (including consumables), yet still offers an amazingly powerful mapping solution to profile gene expression that can readily assess a patient’s risk. Prosigna is designed specifically as a prognostic tool for assessing susceptibility to distant recurrence and thus can give oncologists and pathologists a quick way to test their breast cancer patients and give them an idea of their future chances.
The target window is survival at 10 years and Prosigna is indicated for hormone receptor-positive breast cancer postmenopausal women with one to three positive lymph nodes who’ve done the standard surgery and locoregional treatment. The platform has its own scoring system, the Prosigna Score, which indicates risk of recurrence and a second score which is computed using the Prosigna Score and the overall positive/negative status of the patient’s lymph nodes.
Prosigna landed EU regulatory clearance back in 2012 and launched just this February, so the FDA’s quick decision is a clear endorsement of the platform’s extremely precise, quantitative methodology. This thing is robust too, it actually does single-tube multiplexing of all 50 Prosigna genes in one reaction (using single-molecule imaging) and you don’t need to amplify the reaction as with some other assay technologies because the Prosigna platform is incredibly sensitive and can pull readings with remarkable efficiency, outputting a simple digital bar code. NanoString isn’t screwing around with the product execution either; Prosigna is completely automated, making the tedious and laborious job of testing simpler and easier than what caregivers have come to expect.
The company really has thought this through superbly and is drawing heavily on their established, clinically actionable genomic mapping technologies to offer oncologists and pathologists a really good way to assay small tissue samples and tell the patient what their chances are like. The product execution should have shareholders beaming.
A huge boon for breast cancer sufferers and one that is not a moment too soon either, with the most recent year of data aggregated by CDC (2009) showing over 211.7k cases in the U.S. alone, as well as a tragic 40.6k casualties. These are our mothers, sisters, and daughters dying of what is now the most common cancer among U.S. women (aside from non-melanoma skin cancers) and markets reacted accordingly to the news as shares jumped 66.40% to close $12.68 on Tuesday.
For more info on NanoString Technologies, visit www.NanoString.com
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