Test Description

Several screening programs for cervical cancer have been implemented in the clinical  community, and are comprised of tests based on the appearance of abnormal cells in cytological specimens (Pap smear), and more recently, based on HPV type (HPV testing). HPV is a necessary cause of cervical cancer. However, an abnormal Pap smear coupled with an HPV positive result doesn’t mean that you will get cervical cancer. Indeed HPV infections are cleared within two years of infection in 90% of cases. In addition, HPV-positive women identified with a low grade/undetermined abnormal Pap smear (LSIL or ASCUS) have less than a 6% risk of progressing towards a high grade lesion within five years. Despite this, all HPV-positive women with a low grade/undetermined abnormal Pap smear are still currently reflexed to colposcopy for further analysis, sometimes including excisional procedures (biopsy intended for histology). Therefore there is a need for additional biomarkers in the triage process to limit unnecessary colposcopies and excisional procedures by identifying women with lesions at risk for progressing to a higher grade.

CGI has developed a test that uses leftover cytological specimen so no additional procedure is required. This test relies on fluorescence in situ hybridization (FISH), a method widely used that presents a high sensitivity (aptitude to detect positive specimens). This test is named FHACT® (FISH-based HPV-Associated Cancer Test). It is currently the only FISH test that assesses four different markers of progression at once. These markers correspond to four different irreversible chromosomal alterations in the woman’s genome that are caused by HPV infection. Such alterations are non-random and include gains of specific genomic regions.

Please contact us to get more information. If you would like to be tested with FHACT®, please consult your local care provider and refer to the FHACT® test offered by CGI.

 

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