Introduction -

In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the marketplace changed in the past ten years, and what can companies expect when launching a new value-priced lab test today? Many conferences and publications have discussed “clinical utility” – how it should be defined, how it should be assessed, and what standards should be applied. However, there are many other changes in the payer industry and laboratory industry and in our healthcare system as a whole. This white paper examines major trends that directly impact the laboratory industry from the viewpoint of a startup company with a value priced diagnostic test.

An Informal Landscape For 2013/2014: Evolving Challenges For Value Priced LDTs -

The Successful national launch of the Genomic Health Oncotype DX Test was a landmark event in the evolution of the U.S. Laboratory industry. The Test was commercialized (with Collaboration from NIH investigators), priced at over $3000, And offered the potential to substantially impact the standard of care pathway for small breast cancers in patients nationwide. The Oncotype DX Test was not packaged as a commercial kit, but offered as a sole---source, very complex laboratory---developed test (LDT). As Documented in a 2010 White paper by the consultancy Health Advances, The road from its introduction to coverage for 80% Of U.S. insurance---covered lives took years --- From the market launch in 2004 (accompanied By a New England Journal publication) until early 2008. By The end of 2012, The company was profitable with income on the order of $10M Per year against revenue of some $200M Per year.