PreventionGenetics Receives FDA Approval for its Companion Diagnostic Genetic Test as a Class II Medical Device
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). Developed in collaboration with Rhythm Pharmaceuticals, Inc., the test is the first FDA-authorized Class II molecular companion diagnostic device.
The last thing many people want to think about is their own mortality, which often leaves their families to deal with funeral planning, expenses and, sometimes, unresolved medical decisions. They turn to you as a resource in their time of grief. As a funeral director, your interaction with families during a time of loss is their last opportunity to preserve a loved one’s DNA.
Inherited kidney diseases have an overall prevalence of ~6-8 in 10,000 births in the United States and Europe, and accounts for up to 37% of adults with renal diseases (Cocchi et al. 2020. PubMed ID: 32646915; Connaughton et al. 2019. PubMed ID: 30773290; Lata et al. 2018. PubMed ID: 29204651). Obtaining an early diagnosis for kidney disease is important for establishing optimal maintenance and treatment plans for patients and their families, which is why genetic testing has been increasingly integrated into clinical practice.