> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs PreventionGenetics Companion Diagnostic
- URL: https://www.fdaweb.com/fda-oks-preventiongenetics-companion-diagnostic/
- Published: 2022-07-01T12:00:00.000Z
- Updated: 2026-09-14T17:50:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152223

FDA has approved PreventionGenetics’ POMC/PCSK1/LEPR companion diagnostic genetic test for use with Rhythm Pharmaceuticals’ Imcivree (setmelanotide), indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency. The need for a diagnostic test to confirm variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance has been added to the Imcivree’s label, the company says.