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- NGS FDA
The Oncomine® Dx Target Test-Lung is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table 1 below in accordance with the approved therapeutic product labeling.
List of Variants for Therapeutic Use
Tafinlar® (dabrafenib) in combination with MEKINIST® (trametinib)
L858R, Exon 19 deletions
The test is not indicated to be used for standalone diagnostic purposes, screening, monitoring, risk assessment, or prognosis. Results other than those listed in Table 1 are indicated for use only in patients who have already been considered for all appropriate therapies. Safe and effective use has not been established for selecting therapies using this device for the variants in Table 1 in tissue types other than NSCLC. Analytical performance using NSCLC specimens has been established for the variants listed in Table 2.
List of Variants With Established Analytical Performance Only
The Oncomine® Dx Target Test-Lung is a qualitative diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM™ Dx Instrument System.
Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides from NSCLC
Tumor Size mm2
Resection or Surgical Biopsies
≥1, but <10
9 USS & 1 H&E
2 USS & 1 H&E
Core Needle Biopsies
9 USS & 1 H&E
Tumor surface area greater than or equal to 4mm2 tumor area; tumor content greater or equal to 10%. Resection or Surgical Biopsies: 1 H&E and 2 unstained slides (5 um). Core Needle Biopsies: 1 H&E and 9 unstained slides (5 um)
Indicate date and time of collection on test request form.
Causes for Rejection
Specimens not from NSCLC; tumor block or slides containing no tumor; tumor area <1mm2; tumor content in the region of interest <10%; broken or stained slides; decalcified specimens
Please provide a copy of the pathology report indicating a diagnosis of NSCLC or related ICD10 code on the requistion. Test will be delayed if the pathology report and clinical indication are not received. Please direct any questions regarding this test to customer service at 800-345-4363.