Study Confirms Efficacy of New Cervical Cancer Fluorescence Assay

By LabMedica International staff writers
Posted on 08 Aug 2013

A novel FISH (fluorescence in situ hybridization) assay that simultaneously detects gains at four chromosomal loci is now available to clinical laboratories for the detection of cancerous and precancerous cervical cells.

Chromosomal gains at 3q26, 5p15, 20q13 and at the centromere of chromosome seven (cen7) have been described in cervical precancer and cancer cells. Investigators at the [U.S.] National Cancer Institute (Rockville, MD, USA; www.nci.nih.gov) evaluated a novel FISH-based assay developed by Cancer Genetics, Inc. (Rutherford, NJ, USA) for potential routine use to detect pre-cancerous and cancerous cervical cells.

Image: The FISH-based HPV-associated Cancer Test (FHACT) is a single hybridization assay for the detection of chromosomal regions often observed early in HPV-associated precancers, and as such represent biomarkers of HPV-associated cancer progression (Photo courtesy of Cancer Genetics, Inc.).

Fluorescent in situ hybridization (FISH) is a sensitive and accurate technique that allows the detection of chromosome aberrations. In this method, a single-stranded fluorescent-labeled nucleic acid sequence (probe) complementary to a target genomic sequence is hybridized to metaphase chromosomes and interphase nuclei to detect the presence and absence of a given abnormality. FISH complements traditional cytogenetic karyotype analysis. The chief advantage of FISH is that is can be applied to nondividing cells and a variety of specimen types. FISH is a method of choice for diagnosis, prognosis, treatment response, and minimal residual disease detection in hematopoietic neoplasms (leukemia, lymphomas, multiple myeloma, and myelodysplasia) and solid tumors (breast cancer, non-small-cell lung cancer, colorectal cancer, and cervical cancer).

The Cancer Genetics FISH-based HPV (human papillomavirus)-Associated Cancer Test (FHACT) employs a unique combination of genetic markers to detect genetic abnormalities located at the 3q, 5p, and 20q loci and at cen7. The test can be performed directly on Pap smear or liquid based-cytology and does not require any resampling.

The National Cancer Institute investigators used FHACT to determine chromosomal copy numbers in liquid-based cytology specimens from 168 women. Results reported in the June 13, 2013, online edition of journal Gynecologic Oncology revealed that chromosomal gains at 3q26, 5p15, 20q13 and cen7 were associated with severity of cervical lesions.

Cancer Genetics Inc. expects FHACT to aid in lowering healthcare costs and reducing the number of unwarranted colposcopies by providing genomic information not available until now. To reach this goal the company, in partnership with its distributors and collaborators, will conduct workshops in India and Mexico to accelerate adoption of FHACT amongst the clinical community. FHACT is expected to become available in the US towards the end of 2013.

Related Links:

National Cancer Institute

Cancer Genetics, Inc.