ALK gene rearrangement (2p23) by FISH : 1003130

Please provide most recent Pathology report.

MDFCPCGR2PF or 1003130

ALK; FDA ALK; 2p23-; t(2;5); EML1-ALK

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 area 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

This is an FDA approved test.

An interpretive report will be provided.
This is an FDA approved test.

Non-small cell lung cancer is the leading cause of cancer death worldwide. With a 5-year morbidity rate of 85-95%, there is a pressing need for improvement in identifying patients most likely to respond to specific treatments. ALK gene rearrangements have been observed in non-small cell lung carcinoma and involve an inversion within the short arm of chromosome 2 (between loci 2p21 and 2p23), leading to expression of an EML4-ALK oncogenic protein. Tyrosine kinase inhibitors, targeting the ALK tyrosine kinase, have been demonstrated to reduce lung cancer cell proliferation, resulting in suppression of tumor growth. The therapeutic efficacy of inhibiting ALK in tumors that were selected by ALK positivity using FISH has been demonstrated in an early-phase clinical trial of a small molecule inhibitor of the ALK tyrosine kinase. Additionally, the study reported that sixty-three of eighty-two patients were still receiving therapy at the time of the data cutoff with an estimated probability of progression free survival of 72%.