ROS1 by FISH : 1004689

Please provide most recent Pathology report.

MDFCPROS1 or 1004689

repressor of silencing 1 gene; ROS1 kinase marker; ROS

Tissue.

Paraffin embedded formalin fixed tissue that has been fixed in 10% neutral buffered formalin for at least 6 hours and no longer than 48 hours. Two unstained slides, with tissue of 4 microns in thickness are needed for processing, accompanied by a circled H & E clearly indicating the invasive lung carcinoma to be examined.

Paraffin embedded tissue block: Ambient or on ice pack in summer. Slides: Ambient.

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Monday - Friday

Up to 7 days

Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendmentsof 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

An interpretive report will be provided.

ROS1 is a receptor tyrosine kinase (RTK) implicated in tumor progression and approximately 2% of the non–small cell lung cancer (NSCLC) tumors harbor ROS1 gene rearrangements (fusions). In addition to NSCLC, ROS1 gene rearrangements have also been identified in glioblastoma and cholangiocarcinoma. Emerging preclinical and clinical data indicate that these tumors, harboring ROS1 gene rearrangements are responsive to inhibitors, such as Crizotinib, that were originally designed to target anaplastic lymphoma kinase (ALK). This FISH assay can be used to determine eligibility for tyrosine kinase inhibitor therapy, primarily in individuals with pulmonary adenocarcinomas.