French cellular diagnostics company Novacyt has entered into a strategic alliance with US-based molecular diagnostics company Cepheid to introduce a complete human papillomavirus (HPV) diagnostic system into Latin America.
Under the three year, non-exclusive agreement, Cepheid and its distributor partners will distribute Novacyt’s NOVAprep vial, media and cervical sample collection device which will be used with Cepheid’s Xpert HPV assay (CE-IVD) to detect high-risk HPV infection, either as a primary cervical cancer screen test or as a reflex test to cytology.
NOVAprep is the latest liquid based cytology solution to diagnosis cervical cancer as part of a screening programme and non-gynecological cancers in patients.
It consists of a vial with integrated cell extraction system, a self-sealing cap and preservative media to preserve the cells in a near native state to maintain cell clusters and cell integrity.
The NOVAprep solution is designed to fully automate the process starting from sample to slide and prepares a sample aliquot for molecular testing.
Xpert HPV is designed as a multiplexed test which targets the E6/E7 region of 14 cancer-related HPV types out which types 16 and 18/45 are specifically addressed in separate detection channels, with 11 other high-risk types detected in combined channels.
Data suggested accuracy in results of NOVAprep and Xpert HPV test while examining specimens.
Novacyt Group CEO Graham Mullis said: “We are delighted to announce this strategic partnership with Cepheid, a global leader in molecular diagnostics.
“HPV testing is in a multi-billion dollar market.
“The combination of NOVAprep’s proprietary sample collection and preparation capability together with Cepheid’s diagnostic system positions us well for growth in Latin America.
“Our unique approach will provide significant benefits to patient risk stratification and we look forward to working with Cepheid in this new market and region for Novacyt.”