Is This a Big Opportunity for Diagnostic Test Developers?

Since the inception of this blog over 4 years ago, one of the key topics has been companion diagnostic testing for cytochrome p450 (CYP) mutations. Indeed this was the topic of the very first post. Testing for these mutations is increasing rapidly, but CYPs remain in...

FDA Finally Provides Better Evidence of LDT Risks

For a long time now I have been pushing FDA to provide evidence to back up its claim that LDTs have introduced risk to patient populations. That evidence has now been provided, and it is compelling. FDA has just published a case for LDT regulation based on 20 case...

Upcoming Congressional Hearing on Lab Test Regulation

The U.S. House of Representatives Committee on Energy and Commerce is holding a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations” on November 17 at 2pm ET (note that the date was re-scheduled from an earlier date)....

CMS Plan for Test Pricing Seems to Favor Large Labs

CMS has finally released its plan for market-based reimbursement of lab testing, and early reaction from industry seems to be that large test providers such as Quest and LabCorp will benefit most from the new system. The new system requires that “applicable...