A few weeks ago, when Alberto Gutierrez was quoted saying IVDMIA might go back to "square one," a lot of people in industry assumed it meant that IVDMIA was toast. Although I cautioned against this assumption, it was difficult to dismiss entirely. I had bet a colleague lunch that IVDMIA would be out this summer, for example, and "square one" was more than enough to call the bet in his favor.
Yesterday I was at the annual RAPS conference in Philadelphia and so were director-level OIVD players like Courtney Harper and Elizabeth Mansfield. There weren't any game-changing announcements being made there, but there was a distinct message woven between the lines here: the rumors of IVDMIA's death have been greatly exaggerated.
The biggest announcement was that CLIA tests that are companion diagnostics will no longer be shown enforcement discretion by FDA. That's an intentionally narrow statement, but it's one worth paying attention to. Remember, FDA's position on IVDMIA is that it simply clarifies authority they already have. If IVDMIA stalls out, there's another way to clarify that authority: just start enforcing it.
This won't be FDA's first enforcement action under the IVDMIA rubric, but it is a threshold of sorts. The CLIA companion diagnostics announcement puts into the public sphere what some untitled letter recipients already knew: FDA isn't sitting on their hands waiting.
IVDMIA the document might be dead or might not be. Increasingly, it appears that it may not really matter, because IVDMIA the regulatory framework is alive and kicking. The discussion has shifted from if and is now mostly about how and when.