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Oncomine Dx Target Test pin

PCR

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

Methodology: PCR

Clinical Significance:
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)

Organ: Lung

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

Specimen Requirements:
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