RUO
At AACR's annual meeting, industry observers discussed how FDA's stance on RUOs amid its push to regulate LDTs is putting the "double squeeze" on the lab industry.
The company has pivoted to serve the research market but still hopes to spearhead translation of immunotherapy biomarkers following CLIA validation of its approach.
Q&A: FDA's Alberto Gutierrez, Elizabeth Mansfield Discuss Personalized Medicine Efforts in 2013
Premium
Toward the end of 2013, the US Food and Drug Administration surprised many by taking action on a number of divisive and complex areas in the personalized medicine space.
Originally published Dec. 20.
Originally published Dec. 3.