Now that CMS has posted the interim payment amounts for more than 100 new molecular pathology codes, industry is concerned whether the tests will be covered at all.

FDA's draft guidance on single-laboratory diagnostics may slow down the development of genomic testing in the short term. Over the long term, however, it will help validate the field and create a stronger foundation for personalized medicine.

A small number of start-ups are developing novel specilalty-focused diagnostics that capture drug-like revenues and margins without taking drug-like development and regulatory risks. Questions about the business model abound, since most companies need multiple tests to reach profitability and a changing regulatory climate may force these companies to seek FDA approval for their tests, dramatically increasing development risk and cost.