Breast Cancer Market Sees New FDA Approved Competitor

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]

This entry was posted in Health Care on by .
Ken Powell

About Ken Powell

Ken Powell is the President of Genesis Business Development, a global health care consultancy. Mr. Powell has experience in the identification, acquisition, and commercialization of intellectual property, new businesses, and products in the clinical diagnostics, life sciences and medical device market segments. He has knowledge about emerging technologies, industry consolidation, personalized medicine, molecular diagnostics, hospital, commercial reference and physician labs, clinical lab systems, point-of-care, genomics, proteomics, life sciences, lab distributors and medical devices. He has provided Expert Witness testimony in an international lawsuit at the Royal Court of High Justice, London, England. Mr. Powell is also knowledgeable about evolving clinical diagnostic regulatory (FDA, CLIA, Congressional) and reimbursement issues. He has held senior management positions with Becton Dickinson, Roche Diagnostics, Technicon (Revlon Healthcare), Armour Pharmaceuticals, and Upjohn Clinical Laboratory Procedures. Mr. Powell is conversant in all aspects of clinical diagnostics, life sciences segments, current and emerging companies and select medical device segments. He has provided Expert Witness testimony in an international lawsuit involving infectious disease diagnostic technologies at the Royal Court of Justice in London, England.

Contribute To This Discussion “Breast Cancer Market Sees New FDA Approved Competitor

  1. Pingback: Cancer: Basic Science and Clinical Aspects | BAZAR-A2Z