IntelliGEN Oncology Therapeutic Panel (NGS)

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IntelliGEN Oncology Therapeutic Panel (NGS)

The information provided in this analysis may assist in making cancer treatment decisions involving targeted therapies and other therapeutic indications related to the molecular alterations detected in the tumor sample. IntelliGEN may be useful as a tool in various clinical settings, including: When guideline-recommended biomarker evaluation yields no targeted therapeutic option; When relapse or disease progression has occurred after prior therapy; When the tumor is poorly differentiated and of uncertain origin; When a cancer lacks an effective standard-of-care therapy at the time of diagnosis; When there is limited tissue to perform guideline-recommended biomarker evaluation; When a broad profile of potential gene targets for future clinical trials would be useful; When testing in early-stage cancers in order to have biomarker data available if cancer recurs.

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.

Turnaround Time

14-21 days

CPT

81445

Disease

Different cancer types

Gastroesophageal cancer

Lung Cancer

Non-Small-Cell Lung Cancer (NSCLC)

Ovarian Cancer

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, bone marrow, fine needle aspirate (FNA), solid tumor (excision, core, FNA, or endoscopic biopsies).

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.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.

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. 

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.

Causes for Rejection

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

Storage Instructions

Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.

Test Includes

Includes an assessment of ~2700 mutations within 50 common oncogenes and tumor suppressor genes. Included in the panel are: Genes and their associated variations that are biomarkers for therapies targeting genetic alterations in human cancers; Genes focused on cancer signaling pathways (driver mutations); Genes known to have clinical relevance across multiple tumor types

Use Statement

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 backgound 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.

Synonyms

Oncology Therapeutic Panel

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. PubMed 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. PubMed 23208921

CPT Codes

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

Profile Policy

LabCorp's policy is to provide physicians, in each instance, with the flexibility to choose appropriate tests to assure that the convenience of ordering test combinations/profiles does not prevent physicians who wish to order a test combination/profile from making deliberate informed decisions regarding which tests are medically necessary. All the tests offered in test combinations/profiles may be ordered individually using the LabCorp test request form.

Please remember that (1) when ordering tests for which Medicare or Medicaid reimbursement is sought, the physician should only order those tests that the physician believes are medically necessary for each patient, (2) that using a customized profile may result in ordering tests for which Medicare or Medicaid will deny payment, (3) that the physician should only order individual tests or a less inclusive profile where not all the tests in the customized test combination/profile are medically necessary for an individual patient, and (4) that the United States Department of Health and Human Services, Office of Inspector General, takes the position that a physician who orders medically unnecessary tests may be subject to civil penalties.

LabCorp encourages clients to contact their local LabCorp representative or LabCorp location if the testing configurations shown here do not meet individual needs for any reason, or if some other combination of procedures is desired.

Investigational Procedures

Some of the individual tests and profile test components listed in this Directory may be considered by Medicare or other insurance carriers as investigational procedures, and therefore, the test may not be payable by the carrier as a covered benefit for the patient. Medicare patients must be informed of this possibility when the physician orders tests that may fall into this category. Affected patients must be asked to sign an Advance Beneficiary Notice, agreeing to be financially responsible if the service is denied by the carrier. Additionally, for other insurance plans, physicians should inform the patient that the service(s) may not be covered by their private insurance plan and, if so, they will be financially responsible for payment. If the patient declines to accept financial responsibility, please do not order the test(s).

As with all clinical assays, results of these tests should be used only in conjunction with other medically established diagnostic elements (eg, symptoms, history, clinical impressions, results from other tests, etc). Physicians should use all the information available to them to diagnose and determine appropriate treatment for their patients. In order to obtain a current list of the procedures that may be considered investigational by Medicare or other insurance carriers, please contact your local LabCorp representative.