Oncomine® Dx Target Test-Lung

Oncomine™ Dx Target Test-Lung

CPT: 81445; 88381
Updated on 11/27/2017
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Test Details

Synonyms

  • NGS FDA

Use

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.

Table 1

List of Variants for Therapeutic Use

Gene

Variant

Targeted Therapy

BRAF

BRAF V600E

Tafinlar® (dabrafenib) in combination with MEKINIST® (trametinib)

ROS1

ROS1 fusions

XALKORI® (crizotinib)

EGFR

L858R, Exon 19 deletions

IRESSA® (gefitinib)

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.

Table 1

List of Variants for Therapeutic Use

Gene

Variant

Targeted Therapy

BRAF

BRAF V600E

Tafinlar® (dabrafenib) in combination with MEKINIST® (trametinib)

ROS1

ROS1 fusions

XALKORI® (crizotinib)

EGFR

L858R, Exon 19 deletions

IRESSA® (gefitinib)

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.

Table 1

List of Variants for Therapeutic Use

Gene

Variant

Targeted Therapy

BRAF

BRAF V600E

Tafinlar® (dabrafenib) in combination with MEKINIST® (trametinib)

ROS1

ROS1 fusions

XALKORI® (crizotinib)

EGFR

L858R, Exon 19 deletions

IRESSA® (gefitinib)

Limitations

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.

Table 2

List of Variants With Established Analytical Performance Only

Gene

Variant ID/type

Nucleotide change

KRAS

COSM512

C.34_35delGGinsTT

KRAS

COSM516

c.34G>T

MET

COSM707

c.3029C>T

PIK3CA

COSM754

c.1035T>A

Methodology

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.

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.

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.

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides from NSCLC

Volume

Specimen Type

Tumor Size mm2

Slides Requirement

Resection or Surgical Biopsies

≥1, but <10

9 USS & 1 H&E

≥10

2 USS & 1 H&E

Core Needle Biopsies

≥1

9 USS & 1 H&E

Minimum Volume

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)

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)

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)

Container

FFPE block or slides

Collection

Indicate date and time of collection on test request form.

Storage Instructions

Room temperature

Causes for Rejection

Tumor block or slides containing no tumor; tumor area <1mm2; tumor content in the region of interest <10%; broken or stained slides

Clinical Information

Special Instructions

Please provide a copy of the pathology report 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.

References

Oncomine® Dx Target Test User Guide, Rev C.0, 2017.
Oncomine Dx Target Test User Guide, Rev C.0, 2017.
Oncomine® Dx Target Test User Guide, Rev C.0, 2017.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481475 Oncomine(R) Dx Target-Lung 481477 Result Pending
481475 Oncomine(R) Dx Target-Lung 481478 Director Review Pending
481475 Oncomine(R) Dx Target-Lung 480903 Microdissection Performed 8100-0
481475 Oncomine(R) Dx Target-Lung 481482 PDF Pending
481475 Oncomine(R) Dx Target-Lung 481480 Oncomine(TM) Dx Target-Lung N/A

For Providers

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