FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting

November 28, 2023By Allyson B. Mullen & Jeffrey N. Gibbs

Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29.  The notice (here) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests.”  It is well known in the industry that FDA has been skeptical of multi-cancer (sometimes also referred to as pan-cancer) tests.  Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic.

What is shocking, however, is that the panel meeting was announced on Monday November 13 and FDA only accepted comments until November 15.  Not surprisingly, there were exactly zero comments received prior to November 15.  We cannot recall any other situation where FDA gave stakeholders precisely two days in which to comment.  FDA offers no explanation for either the short advance notice of the meeting or the two-day comment period.  Although comments submitted after November 15 won’t be presented to the panel, FDA says it will still take them “into consideration.”  The docket will remain open through December 29.

The timing of this meeting has certainly raised more than a few eyebrows, particularly given its relationship to the proposed LDT rule (see our prior posts here, here, and here).  Why is the Agency now in such a rush to understand how MCDs should be validated?  Is it that the Agency is preparing from this question from labs that are currently offering/developing MCDs?  Why are the panelists being given such scant background (a mere 6 pages of substantive information in the executive summary)?   While the topic of MCDs is important, it seems like everyone—regulators, labs, patients—deserve a better process to provide thoughtful, informed feedback on important questions regarding MCDs than an extraordinarily hasty meeting.

FDA’s haste is even more surprising given that CDRH has convened only 5 other panel meetings so far in all of 2023.  Further, CDRH announced another panel meeting the same day as the MCD panel notice (November 13) and yet another panel meeting was announced on the day after the MCD panel notice (November 14).  Both of these other panel meetings are scheduled to be held in February 2024, which is months later than the November 29 MCD panel.

The meeting information, including the short agenda and questions, are posted on FDA’s website (here) along with the zoom link.  We hope that interested parties will tune in and file docket comments to make their voices heard both with regard to the process of holding this rushed meeting but also the substance of the topics to be considered.

Categories: Medical Devices