Posted by Michael Wonder on 07 Oct 2023
EntroGen receives FDA approval for CRCdx RAS mutation detection kit as companion diagnostic for Vectibix
3 October 2023 - The US FDA has granted approval for EntroGen's CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), a targeted therapy used in the treatment of colorectal cancer.
This landmark premarket approval marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx is the first approved real-time PCR based test in the US that fully meets the biomarker identification requirement for Vectibix.
