PreventionGenetics, a subsidiary of Exact Sciences Corp., announced today that it was recently granted marketing authorization for the POMC/PCSK1/LEPR companion diagnostic (CDx) genetic test as a Class II device by the Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA). PreventionGenetics, an accredited germline DNA testing laboratory offering genetic testing to patients and physicians around the world, developed the test in collaboration with Rhythm Pharmaceuticals, Inc.
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 (VUS) has been added to the label for IMCIVREE® (setmelanotide), a product marketed by Rhythm Pharmaceuticals that was approved by the FDA in 2020 for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency.
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