NEW YORK – PreventionGenetics said Thursday that it has been granted marketing authorization for its POMC/PCSK1/LEPR companion diagnostic as a Class II device by the US Food and Drug Administration.
The firm, which was recently acquired by Exact Sciences, developed the assay in collaboration with Rhythm Pharmaceuticals to detect variants in POMC, PCSK1, and LEPR genes that have been classified as pathogenic, likely pathogenic, or of uncertain significance, marking patients as eligible for treatment with Rhythm's chronic weight management drug Imcivree (setmelanotide).
Imcivree, which is designed to activate melanocortin-4 receptor, is not indicated for individuals with benign or likely benign variants in POMC, PCSK1, or LEPR, or for other types of obesity not associated with those genes. PreventionGenetics initially partnered with Rhythm in 2019, when the company instituted a free testing program to help advance the drug's development.
Eric Bend, PreventionGenetics' associate lab director, said that the company is proud to now play a part in guiding the clinical use of the first approved drug for genetically mediated obesity.