White Paper

2013-2014: Evolving Challenges for Value-Priced LDTs

September 13, 2013


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.

Download the full content of Evolving Challenges for Value-Priced LDTs (.pdf)