NanoString received FDA approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay. It is the first breast cancer prognostic assay cleared by the FDA for decentralized testing. The company intends to launch the test in the first quarter of 2014.
[protected]Prosigna will compete with the market leader in the breast cancer prognostic space, Genomic Health’s (NASDAQ: GHDX) OncotyeDX. In addition there is Agendia’s MammaPrint, an In Vitro Diagnostic Multi-Variant Index Assay (IVDMIA) used in breast cancer recurrence diagnosis. OncotypeDX is not cleared by the FDA and is available through Genomic Health’s CLIA-certified lab. MammaPrint is one of a handful of complex FDA approved IVDMIAs and is also offered through Agendia’s centralized lab. Now NanoString is seeking to change the competitive dynamics of the market with a business model that is very different from the ones deployed by Genomic Health and Agendia. The market for recurrent breast cancer testing is significant and the entry of another competitor with a new approach will likely grow this market segment at a much faster rate.
For more information on the breast cancer market segments, the competitors in this space and the myriad of issues surrounding them, please contact your Atheneum representative and schedule an individual consult today.[/protected]