Current commercially available PCR tests for HPV require highly skilled laboratory staff, and the tests may not offer the precision required. In addition, these tests take a minimum of eight hours for completion.
With GenoID's diagnostic kit, all 14 high-risk and 5 low-risk genotypes of HPV can be identified. Laboratories can provide test results within three hours, significantly increase the reliability of HPV diagnostics by reducing the number of false results and test repetitions.
Combining the sensitivity and specificity of PCR technology but simplifying the process by using a real-time PCR method achieves this.
In addition, the tests can run on a number of different so-called "open-platform" real-time thermocyclers such as the Roche LightCycler, and Applied Biosystem's ABI 7700.
"This kit contains over 50 artificial DNA sequences making it probably the most complicated PCR reaction ever," said Csaba Jeney, head of research at GenoID.
"With our product, both a small clinic and a high-throughput, fully automated lab can provide HPV testing in a cost efficient manner," said general manager Attila Erdos.
GenoID's new kit comes up against heavy competition, namely in the form of Digene Corp's HC2 and Roche Diagnostics' Amplicor HPV. However, GenoID claim to have the edge on its rivals, boasting a two-step procedure: sample preparation and the test itself as well as the flexibility separately detect the genotypes covered by the upcoming vaccines (6, 11, 16, 18)
In addition, GenoID's test targets part of the L1 sequence, which has conserved and diverse segments. These are needed for robust amplification and for high specificity.
PCR is commonly used in medical and biological research labs for a variety of tasks, such as the detection of hereditary diseases, the identification of genetic fingerprints, the diagnosis of infectious diseases, the cloning of genes, and paternity testing.
It is a molecular biological technique for amplifying (creating multiple copies of) DNA without using a living organism. The technique allows a small sample of DNA to be copied multiple times so it can be used for analysis.
Human papillomavirus, is a DNA tumour virus that has been suspected of having an etiologic role in skin diseases and most importantly in cervical carcinoma, anogenital carcinomas and laryngeal carcinoma.
It is well known that the presence of human papillomavirus shows strong correlation with the incidence of these tumours, and their pre-cancerous states. HPV can be detected in almost 100 per cent of the cervical carcinoma patients.
Current estimates place 20 per cent of sexually active US population is believed to be infected with HPV at any one time.