Molecular diagnostics company Alercell will begin distributing an HPV DNA based test kit, the Meltpro HPV genotype test, which is based on DNA sequencing analysis.
The Meltpro HPV genotype test follows some simple steps in detecting high-risk human papillomavirus. The analysis of genotypes involves a single step procedure almost similar to a real-time polymerase chain reaction. It takes two and half hours to detect and analyze the high-risk genotypes.
Long-lasting infections with high-risk HPVs can cause cancer in parts of the body where HPV infects cells, such as in the cervix, oropharynx, anus, penis, vagina, and vulva.
HPV infects the squamous cells that line the inner surfaces of these organs. For this reason, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are called adenocarcinomas.
“A woman dies from cervical cancer every 2 minutes globally WHO is predicting that the death rate from cervical cancer will increase by nearly 50% by 2030, to me this is intolerable,” says Frederic Scheer, CEO of Alercell.
Cervical carcinoma is the second in rank of the cancers occurring in females after breast cancer. The age of onset of cervical cancer is between twenty-six to thirty years and between forty to fifty years.
“Similar to the recent announcement we did on the Leukemia Fusion Gene Kit, the valuable aspect of the DNA test is the unique combination of accuracy and speed,” says Alexandre Scheer, MD, chief medical officer of Alercell. “The approach is not only innovative but could create a tremendous tool to fight HPV related cancers.”
The traditional approach is done through blood tests and cytology analysis while the Meltpro HPV DNA test analyzed the specimen through a standard PCR machine eliminating the risk of human interpretation. Results can be obtained in less than three hours at a fraction of the costs of the traditional approach. The Meltpro HPV test reagent can realize single-tube genotyping of all 14 types. This is based on a patented MMCA technology. Until now the existing HPV DNA reagents were able only to detect HPV16 and HPV18 in a single tube.
This new technology is possible with very high melting curve function of the instrumentation used for the tests. Alercell is offering the instrumentation to go along with Meltpro HPV Tests both the SLAN 96S and the new Sanity 2.0 designed by Zeesan Biotech.
“It is important to give practitioners and patients a fast and affordable solution to all the life-threatening conditions that are ravaging the lives of so many,” added Scheer.
The Meltpro HPV genotype test kit will start as Research Use Only while waiting for the final FDA certification to expand the distribution around the country. The test is already available in Europe with a full CE certification.
