GAO Flags Technical Challenges for Disease Diagnostic Devices

September 15, 2017

Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace.

The report focused on multiplex point-of-care technologies (MPOCTs) used to diagnose infectious diseases by simultaneously testing for the presence of different pathogens.

One obstacle cited was the need to apply for FDA waivers to allow untrained users to operate the devices.

Another obstacle to the use the devices is their cost, which ranges from $25,000 to $530,000, with costs per test ranging from $20 to $200.

The report said technical challenges to developing multiplex assays, which can slow MPOCT development and increase costs, include:

  • The lack of access to patient samples;
  • The lack of reliable genetic data bases;
  • Difficulties associated with modifying the assays, such as the need to consider new interactions based on the modification and the requirement to obtain FDA approval before marketing the modified test;
  • Constraints on what can be detected, in part due to design limitations.

The potential benefits of MPOCTs include improved patient health care and management, more appropriate use of antibiotics, limiting the spread of disease and cost savings. Some stakeholders interviewed by the GAO said more clinical studies are necessary to establish the impact of the MPOCTs on patient outcomes.

Read the full report here: www.fdanews.com/09-15-17-GAOreport.pdf. — Gregory Roberts