Cancer Genetics Inc., an emerging leader in DNA-based cancer diagnostics, announced that it has received a third US patent covering FHACT (US patent number 9,157,129), its proprietary FISH (fluorescent in situ hybridization)-based HPV-associated cancer test. FHACT is primarily used as a diagnostic tool for the detection of cervical cancer and pre-cancers.
This patent is part of a series of patents received for FHACT that provide protections for CGI’s proprietary capabilities for the detection of HPV-associated cancers, which include cervical, anal, head and neck, penile, and vulvar cancers. Cervical cancer is one of the most common HPV-associated cancers, with approximately 528,000 new cases diagnosed annually worldwide.
FHACT uses DNA FISH-probes in the evaluation of biomarkers indicative of HPV-associated cancers in cervical or other cytology specimens. The results provided by the test have the potential to not only improve the clinical management of HPV-positive patients, but also to reduce costs of treatment for patients with abnormal cytology or positive HPV results.
The company recently illustrated the clinical utility and sensitivity of the FHACT test when it presented the results of two clinical studies at the HPV2015 conference in Lisbon, Portugal. In the first study, which was conducted with the National Cancer Institute (NCI) on 296 patients, the FHACT test demonstrated 96.9 per cent sensitivity. In the second study, which included 200 women, conducted in partnership with Kamineni Hospitals in Hyderabad, India, the FHACT test was used in conjunction with molecular detection of HPV and demonstrated 94 per cent sensitivity and specificity.
“Having a total of three patents directed to separate proprietary aspects of our unique FHACT test. Having three patents for FHACT further strengthens our position in this important and underserved category, and highlights the test’s unique ability to advance HPV-associated cancer detection and patient management,” said Panna Sharma, CEO of Cancer Genetics Inc.
“The test has benefits that are important for both patients and providers as FHACT has the ability to repurpose patient samples to avoid additional invasive, time consuming, and costly procedures while also offering high-sensitivity genomic testing with robust performance.”
CGI received its first product design patent (US patent number 8,865,882) for the test’s unique four-probe combination on October 21, 2014. A second patent (US patent number 8,883,414) was granted on November 11, 2014 covering the test’s use on clinical patient samples, including cervical tissue specimens, remnant Pap-smear fluid, and liquid based cytology. The third patent covers the test’s method of analysis for results indicative of HPV-associated cancers or pre-cancers, which enable the appropriate management and triage of HPV-positive patients for treatment.
CGI’s FHACT test accelerates the detection of cancers and precancerous lesions in HPV-positive patients and supports the efficient management of these diseases in an unprecedented way. The award of a third patent further demonstrates the uniqueness of FHACT and strengthens CGI’s position as a leader in the HPV-associated cancer diagnostics market. The FHACT test will be made available through CGI’s national clinical sales force.