HPV test will be combined with Accuri’s flow cytometer to identify those whose infection is progressing to cancer.
IncellDx and Accuri Cytometers are coupling technologies to offer a cervical cancer screening test. Under the supply agreement, IncellDx’ HPV OncoTect™ E6, E7 mRNA test will be combined with the Accuri C6 Flow Cytometer®.
The HPV OncoTect E6, E7 mRNA test quantifies overexpression of E6/E7 mRNA in each cell as well as the total proportion of cells that are overexpressing. This information may provide a more specific indication of whether an HPV infection is transforming into cervical cancer, according to the companies.
HPV OncoTect can be used on routine liquid-based cytology samples and provides results in about 3.5 hours, IncellDx reports. An automation upgrade is also available that allows 96 samples to be processed in two hours.
It is CE marked and is available in Europe, South America, and Southeast Asia. Neither the Accuri C6 nor the HPV OncoTect E6, E7 mRNA kit has been cleared by the FDA.
“The robust, benchtop flow cytometer system has demonstrated excellent performance when combined with reagents from the HPV OncoTect E6, E7 mRNA kit,” says Bruce K. Patterson, M.D., CEO of IncellDx. “With this agreement IncellDx will have an automated, complete solution for cervical cancer screening, with the potential to be widely disseminated in the global market.”
The C6 flow cytometer also performs additional tests from the IncellDx product line, including the HIVTROPISM Probe and the HCVVR Viral Reservoirs Probe. These probes are currently available for research use only.