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36442: Oncomine(tm) Dx Target Test Print View
Clinical Indication      
Sample Type      
Sample Source      
Specimen ID      
Summary      
Technical Results      
Interpretation      
Intended Use      
Methods      
Comments      
References      
Assay Details      
Report ID      

PRIMARY
1 Slides (Unstained)   Room Temperature - 8 Month(s)  
2 FFPE Tissue (Block/Slide)   Room Temperature - 8 Month(s)  
ALTERNATE

The Oncomine(TM) Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel sequencing technology 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 PGM(TM) 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(R) (dabrafenib) in combination with MEKINIST(R) (trametinib) ROS1 fusion: XALKORI(R) (crizotinib) EGFR L858R mutation and Exon 19 deletions: IRESSA(R) (gefitinib)

For resection or surgical biopsies, the recommended tissue input is
2x5-micron sections
For core needle biopsies, the recommended tissue input is 9x5-micron
sections
Setup Schedule
Tuesday, Saturday

Reported (Analytical Time)
10 days

CPT Code
0022U

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Notes
Methodology: Next Generation Sequencing
Transport Temperature: Room Temperature
Specimen Requirements:
Preferred: Formalin fixed paraffin embedded tissue collected in an IHC Specimen transport kit
Acceptable: Unbaked, unstained slides
Reject Criteria: Tumors other than NSCLC
Unacceptable: Refrigerated and Frozen






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