CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
Tag: fda ldt
IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging.
The companies are diverging because of a major acquisition made in February 2015, by Laboratory Corporation of America. LabCorp bought Covance Inc. in a deal valued at
IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging