QIAGEN Collaborates with BioNTech on Companion Diagnostics Development for HPV-associated Squamous Cell Carcinoma of the Head and Neck

• QIAGEN and BioNTech to develop tissue-based therascreen® test covering a panel of HPV genotypes, paired with investigational treatment BNT113, to identify patients whose cancers are caused by HPV infections
• QIAGEN to pursue global regulatory approvals, including Premarket Approval from FDA for companion diagnostics
• Collaboration leverages QIAGEN´s global reach and market-leading position in companion diagnostics and HPV testing

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a strategic collaboration with BioNTech SE (Nasdaq: BNTX) to develop and commercialize a tissue-based companion diagnostic – to be used with investigational cancer treatment BNT113 – which identifies patients with squamous cell carcinoma of the head and neck (SCCHN) that are caused by specific infections by human papilloma virus (HPV).

The assay will detect the presence of HPV genotypes and will be developed on QIAGEN´s RGQ MDx platform, a member of the QIAsymphony family of products.

QIAGEN plans to expand the panel for use across HPV-driven cancers such as cervical cancer and other cancers, in order to provide a universal HPV companion diagnostic (CDx) for QIAGEN’s pharmaceutical partners.

Head and neck squamous cell carcinoma is the sixth most common cancer. Every year, there are more than 650,000 cases leading to 330,000 deaths, according to a 2018 global cancer study. These numbers are expected to double by 2035, according to the World Health Organization. The incidence of HPV-related SCCHN has significantly increased in recent years.

QIAGEN established the global HPV testing market over two decades ago. More than 100 million women have been tested for HPV infections using QIAGEN´s portfolio of HPV products, including hybrid capture, genotyping, and methylation tests.

Please find the full press release here