We are proud to announce that PhenoPath is now a Quest Diagnostics Company.
Alternate Test Names:
MEKINIST, ROS1 fusion, Gefitinib, XALKORI, Cancer Companion Dx, Lung cancer companion Dx, Companion Diagnostics, NSCLC, Non small cell lung cancer, Crizotinib, Trametinib, Companion Dx, EGFR, NGS lung cancer, TAFINLAR, Dabrafenib, IRESSA, BRAF
The OncomineTM Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel sequencing technology (NGS) to detect single nucleotide variants (SNVs), deletions in 23 genes from DNA, and fusions in ROS1 from RNA. Specimen extracts are isolated from formalin-fixed, paraffin- embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) and analyzed using the Ion PGMTM Dx System. These genes are well characterized in the published literature and associated with oncology drugs that are FDA approved, part of National Comprehensive Cancer Network (NCCN) guidelines, or in clinical trials.
The test is indicated to aid in selecting non-small cell lung cancer (NSCLC) patients for targeted therapies as seen below:
BRAF V600E mutation: TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib)
ROS1 fusion: XALKORI® (crizotinib)
EGFR L858R mutation and Exon 19 deletions: IRESSA® (gelfitinib)
Disease State: Non Small Cell Lung Carcinoma (NSCLC)
CPT Code(s): 0022U (reference only; CPTs may vary)
Turnaround Time: Within 10-14 business days of receipt
Schedule: Monday - Friday
Formalin-fixed, paraffin-embedded (FFPE) tissue block preferred; unbaked, unstained slides acceptable.
For resection or surgical biopsies, the recommended tissue input is 2 x 5-micron sections
For core needle biopsies, the recommended tissue input is 9 x 5-micron sections