NEW YORK (GenomeWeb News) – Enzo Biochem announced today that its Enzo Clinical Labs subsidiary has reached a deal to market a test based on IncellDx's HPV OncoTect technology.
HPV OncoTect will be validated in-house at Enzo Clinical labs, after which the company will seek approval in New York State to market the assay as a laboratory-developed test. If approved, Enzo would become the first New York licensed reference lab offering the test, it said.
IncellDx's test is for the prediction of patients with human papillomavirus who may be at risk of the disease progressing to cervical cancer. It detects and quantifies the expression of viral oncogenes responsible for triggering progression to cervical cancer, "thus improving the specificity that existing tests lack," Enzo said in a statement.
HPV OncoTect is based on a technology called simultaneous ultrasensitive subpopulation staining/hybridization in situ, or SUSHI, a method to get IncellDx's reagents into a cell in order to amplify signals.
IncellDx said earlier this year that it plans to run a clinical trial for the HPV OncoTect in preparation for a submission to the US Food and Drug Administration for marketing clearance.
Financial and other terms of the deal with Enzo were not disclosed.