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Qiagen, Inovio to Develop CDx for Immunotherapy Targeting Precancerous Cervical Lesions

NEW YORK – Qiagen and Inovio Pharmaceuticals are collaborating to develop a companion diagnostic to guide clinical decision making related to Inovio's DNA-based immunotherapy for cervical dysplasia caused by human papillomavirus.

Inovio's VGX-3100 is a late-stage investigational product candidate with potential to become the first treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions associated with the virus. Specifically, the test is under investigation for treatment of infection with HPV 16 and HPV 18 and precancerous lesions of the cervix (Phase 3), and the vulva and anus (Phase 2).

"Our team has deep experience in HPV-related molecular testing and cervical cancer and is looking forward to applying this expertise in partnership with Inovio," Qiagen CEO Peer Schatz said in a statement. "This project is also a case study of a collaboration that started in the discovery phase, when Inovio selected Qiagen Genomic Services to work on the discovery of novel biomarkers that now contribute to the power of this unique molecular assay."

Schatz noted that the project progressed into development and Inovio now aims to make regulatory submissions for VGX-3100 in 2021.

Qiagen currently markets the Digene Hybrid Capture 2 High-Risk HPV DNA test for HPV screening, but has seen its market leadership with this assay whittled away over the past few years by competing tests.

The company also developed the CareHPV test, which also uses the hybrid capture technology, to address cervical cancer in low-resource areas, and recently expanded its portfolio to include two PCR-based technologies: the QiaSure Methylation Test to differentiate patients' risk of developing cervical cancer after a positive test for high-risk HPV; and the QiaScreen HPV PCR test, which will soon be available on its recently launched NeuMoDx platform in Europe.

Qiagen and Inovio did not specific which testing modality would be used in the CDx development project.