This test uses targeted next-generation sequencing to evaluate for somatic mutations within the EGFR, BRAF, KRAS, HRAS, NRAS, ALK, ERBB2, and MET genes. Next-generation sequencing is also used to identify rearrangements (fusions) involving ALK, ROS1, RET, and NTRK1.
When this test is ordered, slide review will always be performed at an additional charge.
Identifying lung tumors that may respond to targeted therapies by assessing multiple gene targets simultaneously in EGFR, BRAF, KRAS, HRAS, NRAS, ALK, ERBB2, MET, ALK, ROS1, RET, and NTRK1 genes .
Diagnosis and management of patients with lung cancer.
Tissue block should be formalin-fixed, paraffin-embedded.
Stained slide with hematoxylin and eosin and 10 unstained (non-baked, charged slides preferred) with 5-micron thick sections of the tumor tissue.
1-2 cytology slides (direct smears or Thinprep) should be stained and coverslipped with at least 5,000 total nucleated cells (slides will not be returned).
Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded
This test cannot differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk.
This test is not intended for use for hematological malignancies.
DNA variants of uncertain significance may be identified.
A negative (wild-type) result does not rule out the presence of a mutation or rearrangement (fusion) that may be present but below the limits of detection of this assay.
Point mutations and small insertion/deletion mutations will be detected in the EGFR, BRAF, KRAS, HRAS, NRAS, ERBB2, ALK and MET genes only. Gene rearrangements (fusions) involving ALK, ROS1, RET and NTRK1 genes only will be detected. This test does not detect large single or multiexon deletions or duplications or genomic copy number variants in any of the genes tested.
Rare polymorphisms may be present that could lead to false-negative or false-positive results. Test results should be interpreted in the context of clinical findings, tumor sampling and other laboratory data. If results obtained do not match other clinical or laboratory findings, please contact the laboratory for updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.
Reliable results are dependent on adequate specimen collection and processing. This test has been validated on cytology slides and formalin-fixed, paraffin-embedded tissues; other types of fixatives are discouraged. Improper treatment of tissues, such as decalcification, may cause PCR failure.
Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.
Next-generation sequencing has recently emerged as an accurate, cost-effective method to identify alterations across numerous genes known to be associated with response or resistance to specific targeted therapies. This is a single assay that uses formalin-fixed paraffin-embedded tissue or cytology slides to assess for common somatic mutations and rearrangements (fusions) involving 11 genes known to be associated with lung cancer. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with lung tumors. These data can also be used to help determine clinical trial eligibility for patients with alterations in genes not amenable to current FDA-approved targeted therapies.