Mayo Medical Laboratories
Despite Broad Carve-Outs, FDA Final Rule on LDTs Draws Critical Response From Lab Industry
The rule makes explicit that LDTs are subject to FDA oversight but provides for enforcement discretion across a broad range of tests.
US Supreme Court Declines to Hear Case on Patent Eligibility of Diagnostics
The decision means the ruling by an appeals court that Mayo did not infringe on Athena's patent on a method of diagnosing myasthenia gravis will stand.
As PAMA Data Reporting Period Nears, Many Hospital Labs May Not Comply
While the laboratory industry hopes expanded price reporting will mitigate PAMA's impact, many labs, especially on the hospital side, may not be ready.
CDC's MOU will seek to codify lessons learned from the public and commercial lab partnership during the Zika outbreak in the US in 2016.
Feb 28, 2018
Mar 31, 2017