Oncomine® Dx Target Test-Lung

CPT: 88381; 0022U
Updated on 5/28/2019
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Synonyms

  • NGS FDA

Special Instructions

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.


Expected Turnaround Time

10 - 14 days

10 - 14 days




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

> or =, but <10

9 USS & 1 H&E

> or = 10

2 USS & 1 H&E

Core Needle Biopsies

> or = 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)


Container

FFPE block or slides


Collection

Indicate date and time of collection on test request form.


Storage Instructions

Room temperature


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


Test Details


Use

The Oncomine® Dx Target Test-Lung is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.

Table 1

List of variants for therapeutic use

Gene

Variant

Targeted Therapy

BRAF

ROS1

EGFR

BRAF V600E

ROS1 Fusions

L858R, Exon 19 deletions

TAFINLAR® (dabrafenib) in combination with MEKINST® (trametinib)

XALKORI® (crizotinib)

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

KRAS

MET

PIK3CA

COSM512

COSM516

COSM707

COSM754

c.34_35delGGinsTT

c.34G>T

c.3029C>T

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.


References

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
581475 Oncomine(R) Dx Target-Lung 230163 Specimen Status N/A
581475 Oncomine(R) Dx Target-Lung 581476 DNA & RNA N/A
581475 Oncomine(R) Dx Target-Lung 581477 Microdissection Performed N/A
581475 Oncomine(R) Dx Target-Lung 581479 DNA only N/A

For Providers

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf