Traditional study designs are the most suitable way to demonstrate performance of liquid chromatography-mass spectrometry in vitro diagnostic devices, despite their complex nature.
That was the conclusion of several speakers during a May 2 workshop hosted by the FDA at its White Oak campus in Silver Spring, Md.
The event was intended to solicit information on the challenges of validating LC/MS IVDs that identify specific proteins or peptides, as the agency eyes a potential approval pathway for these devices.
While no such tests have been cleared or approved specifically for measuring proteins and peptides, the agency has given the green light to LC/MS IVDs for a number of applications, including screening newborns for metabolic diseases. Further, there are clear benefits for using MS versus FDA-cleared immunoassays for measuring proteins.
The FDA has expressed concerns about reproducability of LC/MS IVDs, and the workshop addressed several questions the FDA laid out in a paper posted ahead of the meeting, including one on study design.
Other questions dealt with sample collection, storage and preparation; standards and internal controls; comparator methods; analytical specificity, harmonization and critical components; and data concerns.
Industry stakeholders expressed reservations about traditional immunoassays. Andrew Hoofnagle of the University of Washington, said the lack of consistent results between platforms remains the biggest problem.
A docket on the topics discussed during the meeting was reopened. Interested parties may comment through June 2.