EUA: Help or Hindrance?
This week, the FDA issued another emergency use authorization (EUA), this time allowing Focus Diagnostics to market and offer its Simplexa™ Influenza A H1N1 (2009) test for use on the 3M™ Integrated Cycler from 3M to CLIA high-complexity laboratories for the duration of the recently-declared national emergency.
For new viruses and in rapidly developing situations, EUAs may be necessary to give laboratorians the tools to monitor and identify infections, but there are concerns that safety and quality are compromised in such situations.
Greg Tsongalis, PhD, an ADVANCE editorial advisory board member and director of molecular pathology at Dartmouth Medical School at the Dartmouth Hitchcock Medical Center, voices these concerns: "With more laboratories becoming involved in molecular testing to some extent, it is clear that something different needs to be done with respect to oversight. Despite this however, the FDA has created an interesting situation for laboratories this flu season by allowing assays to be performed under the EUA label. Without any guidelines for validation requirements under this new label, have we taken a step backwards in allowing any laboratory to perform an assay, which itself has not been well characterized, under the auspices of an EUA? Given the status of most laboratories becoming involved in molecular testing, it seems that this approach would only add to the 'E.'"
What do you think? Are EUAs a necessary measure to give labs the tools they need to stay on top of new developments, or do they only exacerbate the problem?