Oncology Therapeutic Panel (IntelliGEN®)

CPT: 81445; 88381
Updated on 11/1/2017
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Test Details

Synonyms

  • IntelliGEN®

Use

IntelliGEN® is a next-generation sequencing (NGS) panel that contains ~2600 mutations within 50 common oncogenes and tumor suppressor genes. The information provided in this analysis may assist in making cancer treatment decisions involving target therapies and other therapeutic indications related to the molecular alterations detected in the tumor sample.

Limitations

This panel targets 50 genes and a fixed set of mutations. Samples with results reported as "no mutation detected" may harbor mutations that are not detected by the assay. Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 5% of mutant DNA in a background of wild-type genomic DNA.

Genes assessed in this "hot-spot" panel may harbor mutations not detected by this assay. This assay will not detect gene rearrangements or amplifications. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically diagnostic product or procedure.

Methodology

IntelliGEN® is an NGS "hot-spot" panel that contains a single pool of 207 primer pairs used to perform multiplex PCR for preparation of amplicon libraries from genomic "hot-spot" regions frequently mutated in human cancer genes. It covers ~2,600 COSMIC mutations within 50 common oncogenes and tumor suppressor genes.

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, bone marrow, fine needle aspirate (FNA), solid tumor (excision, core, FNA, or endoscopic biopsies) formalin-fixed paraffin-embedded tissue. Fixative should be neutral-buffered formalin. For solid tumor metastatic bone samples, submit a nondecalcified FFPE sample. Decalcified bone biopsies are not acceptable sample types for this test.

Block: Tumor surface area ≥4 mm² and tumor content ≥10%; ≥50% is preferred. See Note.

Unstained Slides: See table below as a guide to the number of slides required to meet the DNA input requirements.

Measured Tumor

Surface Area

Tumor Content (%)

Number of Slides Needed

(Each slide cut in 10-μM sections)

≥4 mm²

≥50%

5 unstained slides and 1 H&E

1−4 mm²

≥10%

10 unstained slides and 1 H&E

Note:

• Tumor surface areas between 1-4 mm² with ≥10% tumor content are less likely to meet the DNA input requirements.

• Tumor surface areas between 1-4 mm² and <10% tumor or below <1 mm² will be considered QNS for analysis.

• If sending a core biopsy, if tumor is <0.5 cm in length it is less likely to meet the DNA input requirements.

• If sending a cell block aspirate, at least eight tumor cell clusters providing 400 to 800 intact tumor cells is needed, or it is less likely to meet the DNA input requirements.

Volume

Five to ten unstained slides at 10-μM and one matching H&E-stained slide or formalin-fixed, paraffin-embedded tissue block, 1 to 2 mL bone marrow, 5 to10 mL FNA.

Minimum Volume

1 mL bone marrow; FNA requires sufficient cells for DNA extraction

Container

Slides, blocks, lavender-top (EDTA) tube, green-top (sodium heparin) tube, FNA in RPMI or CytoLyt® container

Collection

Submit at room temperature. Indicate date and time of collection on test request form. Bone marrow specimens should arrive in the laboratory within 48 hours of collection.

Storage Instructions

Ship at room temperature. If bone marrow specimens are to be stored prior to shipment, store at 2°C to 8°C.

Causes for Rejection

Tumor block containing insufficient tumor; broken or stained slides; clotted bone marrow; bone marrow specimen more than five days old

Clinical Information

Special Instructions

A copy of the original pathology report is required for testing. If a pathology report is not received with the sample, testing will be delayed. Please direct any questions regarding this test to customer service at 800-345-4363.

References

Beadling C, Neff TL, Heinrich MC, et al. Combining highly multiplexed PCR with semiconductor-based sequencing for rapid cancer genotyping. J Mol Diagn. 2013 Mar; 15(2):171-176. 23274167
Merriman B; Ion Torrent R&D Team, Rothberg JM. Progress in ion torrent semiconductor chip based sequencing. Electrophoresis. 2012 Dec; 33(23):3397-3417. Erratum: 2013 Feb; 34(4):619. 23208921

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
489600 IntelliGEN(SM) 489613 IntelliGEN(SM) 51969-4
489600 IntelliGEN(SM) 480903 Microdissection Performed 8100-0
489600 IntelliGEN(SM) 489602 IntelliGEN(SM) Putaway N/A
Reflex Table for IntelliGEN(SM)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 511965 Result 511965 Result Pending

For Providers

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CPT Statement/Profile Statement

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