Genomadix Genetic Test for Potential Drug Effectiveness Cleared

Genomadix has received FDA clearance for its Cube CYP2C19 test for assessing the potential effectiveness of drugs metabolized by the CYP450 2C19 genetic pathway.

The polymerase chain reaction test, which determines the presence of several gene mutations from swab taken from inside the mouth, delivers results in about an hour.

The in vitro diagnostic test is also CE-marked and distributed in Europe and in countries that recognize the CE-IVD mark.