oncoFISH cervical Test Description

The oncoFISH® cervical test from Ikonisys Clinical Laboratories is a qualitative fluorescence in situ hybridization (FISH) test for determining the acquisition of specific chromosomal aneuploidies within the 3q26 region in cytological specimens revealing LSIL.  Until now, routine testing for 3q gain was not feasible because assessment required analysis of a large number of stained, squamous cell nuclei - impractical for manual methods.  By using the Ikoniscope®  Digital Microscopy System to automate analysis, the oncoFISH cervical test makes testing for 3q gain a practical reality.

The test is performed on cervicovaginal cytology specimens, identical to those used for Pap and HPV testing.  It assesses amplification of the 3q26 region by use of two FISH probes, one for the 3q26 locus and a control probe.  Enumeration and comparison of the 3q26 and control probes, in conjunction with the nuclear morphology, result in a 3q copy number for each of the nuclei analyzed.

oncoFISH cervical results are intended for use with other clinical findings for further evaluation and monitoring of cervical dysplasia in women with LSIL Pap results.  The oncoFISH cervical test is a laboratory developed test and is intended to supplement, and not replace or alter the current standards of practice used for the clinical management of women undergoing evaluation for cervical dysplastic lesions.  oncoFISH cervical test results should be considered by the clinician in the context of other testing when formulating clinical management.

"...the detection of 3q gain and amplification of TERC
in routinely collected Pap smears can assist in identifying low grade lesions with a high progression risk and in decreasing false-negative cytological screenings." (Heselmeyer-Haddad, K, et al. 2005)