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Qiagen, Inovio Expand CDx Partnership, Starting With NGS Test for Cervical Dysplasia Therapy

NEW YORK – Qiagen and Inovio Pharmaceuticals said on Wednesday that they have signed a new master collaboration agreement to develop liquid biopsy companion diagnostic tests based on next-generation sequencing to complement Inovio's therapies.

The initial project of the expanded collaboration focuses on the development of a diagnostic test to identify women most likely to benefit from VGX-3100, Inovio's immunotherapy to treat advanced cervical dysplasia associated with human papillomavirus infection.

Qiagen said it will use its bioinformatics expertise to further increase the predictive power of Inovio's current biomarker signature, and the assay will be developed for use on the Illumina NextSeq 550Dx sequencing platform.

Qiagen and Inovio originally inked a CDx development deal in early 2019 but did not specify at the time which technology would be used for any tests. The expanded agreement is Qiagen's first CDx development deal that is based on a partnership between Qiagen and Illumina signed in October 2019.

VGX-3100 is Inovio's late-stage DNA immunotherapy candidate. It is currently in two Phase III trials (REVEAL 1 and REVEAL 2) with the potential to become the first non-surgical treatment for advanced pre-cancerous cervical lesions associated with HPV, specifically HPV16 and HPV18.

The new master collaboration agreement also covers the development of companion diagnostics for Inovio's HPV therapies for a range of other sample types and technologies, including NGS and PCR, Qiagen said.