Cepheid announced the release of Xpert HPV, a 60-minute test for cervical cancer-related human papillomaviruses to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices.
The test runs on Cepheid’s GeneXpert System, the world’s leading molecular diagnostic platform. Xpert HPV is a multiplexed test that targets the E6 and E7 oncogenes of 14 cancer-related HPV types and specifically calls out high-risk types 16 and 18/45 in separate detection channels, with 11 other high-risk types detected in a combined channel.
Cepheid Chairman and CEO John Bishop said accurate detection of HPV, along with specific identification of the most problematic types, is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer.
"Xpert HPV is a major addition to Cepheid’s portfolio of Xpert tests, and one that can help to ensure women at risk for cervical cancer get the care they need immediately," Bishop added.
"As with all of our tests, Xpert HPV delivers accurate results to assist clinicians in better managing their patients early, before complications arise."
Early detection of the high-risk HPV DNA responsible for E6/E7 oncoprotein expressed in cervical cells is critical. Viral oncogenes E6 and E7 lead to cell cycle modifications which support conditions favorable to HPV viral replication. HPV viral genome integration into the host DNA, and E6/E7 oncoprotein expression correlate to the development of cervical cancer.
Cepheid chief medical and technology officer Dr David Persing said cervical cancer is a preventable disease — and it is well documented that HPV is the cause. Women deserve improved access to screening tools to significantly reduce their risk of developing this disease.
"Xpert HPV is unlike any test currently available. It’s essentially a cellular analysis in a cartridge, and can quickly help physicians to risk stratify patients," Dr Persing added.
"It is the only diagnostic test that leverages the combined power of cell capture and HPV genotyping to identify women in need of follow-up."