Published on: Tuesday, December 2nd, 2014
FHACT, CGI’s Fish based HPV Associated Cancer Test, helps take the guess work out of cervical cancer screening.
There is significant need for additional biomarkers in cervical cancer screening. Liquid cytology testing (pap smears) has imperfect sensitivity leading to too many false negatives. Additionally, results can be uncertain, especially for specimens with mild cellular abnormalities. Finally, cytology cannot predict disease progression.
HPV genotyping doesn’t distinguish between transient and persistent infection. Due to poor specificity, HPV typing leads to too many “false positives” and only detects the most common high risk HPV strains. Additionally, most infections will clear on their own within 2 years.
The current screening protocol may lead to over treatment. Most LSIL patients are reflexed to colposcopy (70 – 90 percent are HPV positive) but only about 20% of LSILs present CIN2+ (medically actionable) by histology. Approximately 40% of ASCUS, LSIL specimens that that are referred to colposcopy come back with a normal colposcopy result.
FHACT aids in the triage of LSIL and ASCUS lesions. FHACT can identify women with low grade or undetermined lesions who are likely to progress to more advanced cervical disease. FHACT assesses non random genomic alterations associated with progression of cervical disease. Gain at any of the FHACT loci is detected in up to 89.5% of all cervical cancers, making it the highest sensitivity test in its category.
Include FHACT as additional triage before referral for colposcopy. FHACT requires no re-sampling. With FHACT, fewer women are referred for colposcopy. Other benefits of FHACT include reduced healthcare costs, reduced patient anxiety, and additional confidence when selecting treatment options.
Infection with high risk HPV is the necessary cause, but is not sufficient alone, for the initiation of cervical oncogenesis. Additional genetic events in the host’s cells are essential for precancerous lesions to progress to malignancy. Genomic changes are the hallmark of cellular transformation. FHACT looks for these genomic in the woman’s DNA.
Reduce overtreatment, improve women’s health using FHACT, the only test with four biomarkers that detects genomic alterations associated with progression of cervical lesions. FHACT is performed on remnant liquid cytology (pap smear) sample, meaning no resampling is necessary. It may help prevent complications associated with overt treatment.