EGFR Mutation Analysis - cobas® V2 Assay - Plasma

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EGFR Mutation Analysis - cobas® V2 Assay - Plasma

The FDA-approved cobas® EGFR mutation test v2 is a real-time PCR test for the qualitative detection of defined mutations of the EGFR gene in DNA derived from plasma from non small-cell lung cancer (NSCLC) patients.  Plasma testing for EGFR mutations allows accessibility to testing for patients in which the tumor biopsy was inadequate or insufficient in tumor content or in which obtaining a tissue biopsy is not feasible.  The test identifies 42 mutations in exons 18, 19, 20, and 21 of the EGFR gene including the EGFR resistance mutation T790M.

Methodology

Genomic DNA was isolated from the provided tumor specimen using the cobas® cfDNA Sample Preparation Kit for plasma. Mutation detection is achieved through real-time PCR analysis on cobas® z480 analyzer. The cobas® EGFR Mutation Test v2 detects the following mutations: exon 18 (G719X), exon 19 (deletions and complex mutations), exon 20 (S768I, T790M, insertions) and exon 21 (L858R, L861Q). 

Turnaround Time

5-7 days

CPT

81235

Disease

Non-Small-Cell Lung Cancer (NSCLC)

Lung Cancer

Specimen

Plasma (K2EDTA), FROZEN

Volume

4 mL frozen plasma from K2EDTA tubes

Container

BD K2EDTA 4 mL blood collection tubes. Collect three tubes of whole blood in accordance with the collection instructions specified below.

Collection

It is recommended that patients be referred to a LabCorp Patient Service Center for collection. Otherwise, take care to follow the procedure of specimen collection and preparation outlined below:

 

Blood Collection

Blood should be collected according to your laboratory’s procedure for venipuncture using ONLY BD K2EDTA 4 mL blood collection tubes. Plasma preparation should be performed within 4 hours after blood is collected. Store, transport and ship plasma at frozen condition only. The plasma sample can be stored frozen, at <-70°C for up to 12 months. 

Note: Do not freeze whole blood samples.
 
Plasma Specimen Preparation

• Immediately following specimen collection, label all tubes with appropriate patient identification information (two patient identifiers, minimum and label "plasma" on transport tube).
• The brake setting of the Drucker 642e at LabCorp service center is at 3 or 4 (manufacture setting).
• Centrifuge the three, BD K2EDTA blood collection tubes for 10 min at 1600 ± 90 rcf.  [For conversion of RPM (revolutions per minute) to rcf (relative centrifugal force), refer to the centrifuge manufacture’s user manual]
• Remove blood collection tubes from the centrifuge (plasma sample will be rejected if it is hemolyzed).
• Using a fresh 6 inch disposable transfer pipette, transfer plasma from three, 4 mL blood collection tubes to one 8.5 mL Sarstedt centrifuge tube (55.598.006). One, 8.5 mL tubes will be collected from three, 4 mL blood collection tubes.
• Centrifuge plasma in the 8.5 mL centrifuge tube for 10 min at 1600 ± 90 rcf.
• Using a fresh, 6 inch disposable transfer pipette or serological pipette, transfer 4 mL of plasma from one 8.5 mL centrifuge tube into a labeled 7.0 mL Sarstedt screw cap, flat bottom purple frozen transport tube (62.550.019). One, 7.0 mL tube will be collected.
• Ship and store frozen plasma at <-70°C. Stable for up to 12 months.

Note: Take care not to disturb or transfer the buffy coat (white blood cells) layered above the red blood cells in the blood collection tube after the first centrifugation or sedimented at the bottom of the centrifuge tube after the second centrifugation.

Causes for Rejection

Hemolyzed blood; Plasma not frozen; Plasma volume <2mL per tube. Leaking or broken tubes.

Storage Instructions

Frozen; The plasma sample could be stored frozen, at <-70°C for up to 12 months. 

Use Statement

The FDA-approved cobas® EGFR mutation test v2 is a real-time PCR test for the qualitative detection of defined mutation in exon 18, 19, 20 and 21 of the EGFR gene in non−small-cell lung cancer (NSCLC) patients. The FDA-approved plasma test is indicated as a companion diagnostic to aid in identifying NSCLC patients for treatment with the targeted therapies erlotinib (TARCEVA®) or osimertinib (TAGRISSOTM).

  • TARCEVA – Exon 19 deletions and L858R mutations
  • TAGARISSO – T790M mutations

Limitations

Detection of mutation is depended 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 mutations with ≤100 copies of mutant DNA per mL of plasma using the standard imput of 25uL of DNA stock per reaction well.

Synonyms

epidermal growth factor receptor

References

1.  Cobas® EGFR Mutation Test v2 (IVD) [package insert]. Indianapolis, Ind: Roche; Nov 2015.
2.   Jänne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: Implications for treatment and tumor biology. J Clin Oncol. 2005 May 10; 23(14): 3227-3234. PubMed 15886310

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.