Color’s HPV laboratory developed test (LDT) is the first of its kind in the US to use a non-invasive, self-collected urine sample.
Self-collected urine samples are processed in Color’s CLIA-certified and CAP-accredited labs.
Color’s test uses the BD Onclarity™ Human papillomavirus (HPV) assay, which has been cleared by the U.S. Food and Drug Administration (FDA) for use with cervical swab specimens. Color has validated the assay specifically for use on first-void urine specimens, using a Colli-Pee® urine collection device, which makes collection easy and non-invasive. Color's HPV test is not FDA approved or FDA cleared. Rather our test is an LDT, regulated by CLIA. It is a modification of an FDA approved test, with an unapproved sample type.
High-risk HPV types 16, 18, and 31 are individually reported. High-risk HPV types 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 are detected but not individually reported (these are referred to as “other high-risk HPV types” on the report).