PreventionGenetics Gets Marketing Authorization for Molecular Companion Diagnostic Device

PreventionGenetics, a subsidiary of Exact Sciences Corp., received FDA’s marketing authorization for a companion diagnostic genetic test for use with Rhythm Pharmaceuticals’ obesity drug, Imcivree (setmelanotide).

The test specifically detects pathogenic variants in the POMC, PCSK1 or LEPR genes that are linked to obesity. It is not intended for general obesity, which is “a multifactorial condition influenced by multiple genes and environmental factors,” the company said.

The FDA approved Imcivree in 2020 for chronic weight management in adult and pediatric patients six years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency.