This Trovagene test represents a new approach to the identification and detection of the BRAF V600E mutation. Using cell-free DNA from urine we can deliver an accurate and sensitive assay of mutational status.
This is a laboratory developed test (LDT). This test was developed and its performance characteristics determined by Trovagene. It has not been cleared or approved by the FDA as clearance or approval of LDTs is not currently required. This test is used for clinical purposes and should not be regarded as investigational or for research use.
Trovagene's laboratory is certified by the State of California
LICENSE CLF 00338242 in compliance with CLIA (Clinical Laboratory Improvement Amendments) LICENSE 05D1094618, and is accredited by the College of American Pathologists LICENSE LAP 7190902.