Developed in partnership with Rhythm Pharmaceuticals, the test is the first Class II molecular companion diagnostic tool approved by the FDA
PreventionGenetics has received marketing authorisation from the US Food and Drug Administration (FDA) for the POMC/PCSK1/LEPR companion diagnostic (CDx) genetic test as a Class II device.
The approval was granted by the FDA’s division Center for Devices and Radiological Health (CDRH).
PreventionGenetics, a clinical DNA testing laboratory, developed the test in partnership with the Rhythm Pharmaceuticals.
According to the firm, the test is the first Class II molecular companion diagnostic tool approved by the FDA.
The label for IMCIVREE (setmelanotide), marketed by Rhythm Pharmaceuticals, has been updated to show the requirement for a diagnostic test to confirm variants in the POMC, PCSK1 or LEPR Genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
The product was approved by the FDA in 2020 for the chronic management of obesity in adult and paediatric patients aged six years and older who have POMC, PCSK1 or LEPR deficiency.
PreventionGenetics, a subsidiary of Exact Sciences, said that there is a difference between disorders of obesity brought on by single-gene variations (monogenic) and general obesity, a complex condition impacted by several genes and environmental variables.
Monogenic obesity is highly uncommon, with a frequency of less than 4% in people with early-onset obesity, like many other hereditary illnesses.
By locating these people through genetic testing, a focused medicine may be prescribed for them, assisting in the relief of an otherwise crippling ailment, said the firm.
PreventionGenetics associate laboratory director Eric Bend said: “We’re proud to play a part in identifying people with severe obesity who may benefit from taking IMCIVREE, the first FDA-approved therapy for people with severe obesity potentially caused by certain genetic deficiencies.”
The POMC/PCSK1/LEPR companion diagnostic (CDx) genetic test must be ordered by a certified professional in compliance with clinical laboratory rules and is only intended for in vitro diagnostic usage.