The test will be used to identify patients with squamous cell carcinoma. Credit: Ed Uthman.

Qiagen and BioNTech have announced a strategic collaboration to develop and commercialise tissue-based therascreen test to identify patients with squamous cell carcinoma of the head and neck (SCCHN).

They are caused by specific infections by human papillomavirus (HPV).

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The test will be used along with BioNTech’s investigational cancer treatment, BNT113.

To be developed on Qiagen’s RGQ MDx platform, the assay can potentially detect the presence of HPV genotypes.

Qiagen also plans to expand the panel to be used across different HPV-driven cancers, including cervical cancer, and other cancers to offer a universal HPV companion diagnostic (CDx) for its partners.

Qiagen senior vice-president and Molecular Diagnostics Business Area head Jean-Pascal Viola said: “This CDx project will help to identify patients who might benefit from BioNTech’s innovative BNT113 treatment option.

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“Qiagen’s Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to aid in evaluating patients with squamous cell carcinoma of the head and neck.”

The company plans to commercialise the new HPV companion diagnostics in all target markets of BioNTech.

BioNTech is planning to initiate a randomised Phase II trial of BNT113 in HPV16+ head and neck cancer, currently under review by the US Food and Drug Administration (FDA).

Qiagen possesses expertise in technologies, including polymerase chain reaction (PCR) and next-generation sequencing (NGS), used in the companion diagnostic development.

Earlier this week, Qiagen launched multiplex PCR test that can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and SARS-CoV-2 infections in 80 minutes.

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