The alliance will leverage Qiagen’s expertise in HPV-related molecular testing and cervical cancer. Credit: QIAGEN N.V.

Qiagen has partnered with US-based Inovio Pharmaceuticals to create a companion diagnostic to identify patients who are most likely to respond to the drugmaker’s new immunotherapy, VGX-3100.

VGX-3100 is a DNA-based therapeutic meant for the treatment of cervical dysplasia caused by human papillomavirus (HPV). The compound is currently undergoing two Phase III clinical trials.

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If approved, VGX-3100 is expected to be the first therapy for HPV infection of the cervix as well as the first non-surgical treatment for precancerous cervical lesions caused by the virus.

The alliance will leverage Qiagen’s expertise in HPV-related molecular testing and cervical cancer.

Qiagen CEO Peer Schatz said: “We are pleased to support Inovio by developing a liquid biopsy-based companion diagnostic to identify patients who would benefit from VGX-3100, which has potential to make a dramatic difference in the detection of HPV infections and treatment of precancerous disease.

“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. The project progressed into development and Inovio now aims to make regulatory submissions for VGX-3100 in 2021.”

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Qiagen develops molecular diagnostics for screening targets linked to the risk and progression of cervical cancer. Its portfolio includes multiple tests for the cancer.

“A liquid biopsy-based companion diagnostic has potential to make a dramatic difference in the detection of HPV infections and treatment of precancerous disease.”

digene Hybrid Capture 2 High-Risk HPV DNA Test is intended for HPV screening, while QIAGEN’s careHPV Test is meant to help detect the cancer in low-resource regions.

In addition, the QIAsure Methylation Test differentiates patients’ risk for cervical cancer after a positive test for high-risk HPV. The company’s new QIAscreen HPV PCR Test is set to launch in the near future in Europe.

Last month, Qiagen launched a companion diagnostic called therascreen FGFR Kit to identify patients that are eligible for treatment with Janssen Biotech’s fibroblast growth factor receptor (FGFR) kinase inhibitor drug Balversa.