a whole class of technologies that could have a lot of potential for hepatitis c that are just completely stalled on the regulatory side said annette gaudino director of policy strategy at the treatment action groupin november the fda lowered the hurdle by reclassifying hepatitis c diagnostics as medical devices that require less scrutiny asked whether cepheid would consider submitting its test to the fda for review darwa peterson a company spokeswoman said that it was assessing the path forwardsome us clinics noted that even with the advent of automated molecular tests other barriers would remain marguerite beiser who directs hepatitis c services for the boston health care for the homeless program said mobile technologies would be needed to substitute for followup blood and livertests required to begin patients on medications massachusetts would need to drop the requirement that patients get prior authorization from their health insurer before initiating treatment toobut the status quo is dire we are so far behind and were losing ground ms beiser said of the countrys efforts we need to be flexible and use every single tool we have to get it done