Cancer Genetics, Inc. launched its proprietary cervical cancer test and is marketing the molecular product globally through its network of distribution partners. Cervical cancer is the second most common cancer in women worldwide, with 500,000 new cases annually and almost 80% of cases occurring in developing countries.
CGI’s FISH-based HPV-Associated Cancer Test (FHACT™) uses a unique combination of genetic markers to detect genetic abnormalities located at 3q, 5p, 20q and chromosome 7. A recent study concluded that these four biomarkers are associated with the severity of cervical lesions. The findings of the study, published in the July issue of Gynecologic Oncology, http://dx.doi.org/10.1016/j.ygyno.2013.06.005, support the use of FHACT™ as an aid in the screening of women with HPV-positive abnormal cervical lesions. By identifying lesions that will progress to a higher grade versus those that will regress, FHACT™ can allow for a better triage of patients before referral for colposcopy and consequently reduce the associated healthcare burden.
The test can be performed directly on Pap smear or liquid based-cytology and does not require any resampling. It is therefore an ideal fit in countries where women have reduced access to routine screening. “We think that FHACT™ will be a new tool to help identify women with high risk of progressing to cervical cancer,” says Dr. Q. Annie Hasan, Ph.D., F.N.A.Sc., Head of Department and Senior Consultant, Department of Genetics and Molecular Medicine, Kamineni Hospitals, Hyderabad, India. “This is particularly important in India due to the rising incidence of cervical cancer caused by difficulty in implementation of cervical screening programs, which require repeated evaluation in large number of women.” In partnership with its distributors and collaborators, CGI will conduct workshops in India and Mexico to accelerate adoption of FHACT™ amongst the clinical community.
In industrialized countries, it is estimated that about one million women undergo colposcopy procedures each year, while only 3,700 cancer cases are actually diagnosed. The Company expects FHACT™ to aid in lowering healthcare costs and reducing the number of unwarranted colposcopies by providing genomic information of the lesion not available until now. CGI plans to make FHACT™ available in the U.S. later this year and will be working closely with several laboratories and hospitals to implement an early adoption of the test.
The design and development of FHACT™ was supported in part by a Small Business Innovation Research (SBIR) grant. In addition to cervical cancer, FHACT™ is applicable to other HPV-associated cancers. CGI is currently conducting ongoing validations with key thought leaders for head and neck cancer and anal cancer. Results from these studies are expected to be available by year end.