Trailblaze Pharos companion diagnostic receives EU CE mark approval for use with entrectinib in solid tumours- Ignyta

Ignyta has announced that it has received Expedited Access Pathway (EAP) designation from the United States FDA and also CE mark approval for its Trailblaze Pharos companion diagnostic test service. The EAP designation enables Ignyta and FDA to have more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib, the company's investigational, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.

Comment:The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a sequencing based assay for the qualitative detection of fusions in the NTRK1/2/3, ROS1, or ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE) human solid tumor tissue. The assay is intended to be used as an aid in selecting patients, including those who are treatment-na�ve, with solid tumors that harbor a gene rearrangement in NTRK1/2/3, ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be appropriate.