ROS1 FISH

Formalin-fixed, paraffin-embedded tissue blocks; fixed in 10% neutral-buffered formalin for at least 6 hours, and not more than 72 hours. Tissue should be prepared in sections at 4 microns thick. Sections should be mounted on the positive side of an organosilane-coated slide in order to minimize detachment of the tissue from the slide during FISH assay. EDTA decal are accepted.

Gene fusions involving ROS1 are present in 1-2% of nonsmall cell carcinomas, primarily adenocarcinomas. ROS1 fusion is recommended for screening in cases that are EGFR mutation and ALK fusion negative.Resulting activation of ROS1 TK activity appears to be a growth driver in these tumors and can be sensitive to crizotinib (Xalkori)

Surgical pathology report.

Ambient temperature (20-25°C); refrigerated samples acceptable); exposure to acids, strong bases or extreme heat should be avoided.Room temperature or refrigerated. Ship in cooled container during summer months.Specimen not verified for the presence of invasive carcinoma and specimens fixed in fixatives other than formalin are not acceptable. Surgical pathology report should be included. Acid decalcification compromises the specimen quality, EDTA decal is recommended.

Paraffin block with no tumor tissue remaining. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Cytology specimens fixed in alcohol. Decalcified specimens.

10 Years FFPE

This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.