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Response to: “Study results and related evidence do not support use of HPV16 L1 DRH1 antibodies as a cancer screening test”

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We value all comments on our research, and the opportunity to provide further information on our study describing the HPV16-specific tumour marker DRH1 [1]. We used an assay that was… Click to show full abstract

We value all comments on our research, and the opportunity to provide further information on our study describing the HPV16-specific tumour marker DRH1 [1]. We used an assay that was CE certified under the European InVitro Diagnostic Devices Directive, implying compliance with regulatory requirements on documentation and technical validation. This includes assessments of test reproducibility. Significant bias from batch effects can therefore be excluded. Specificity of the assay was assessed in a large control population (n = 1064*, see Table 1) of randomly selected, CRP-negative (<1 mg/ l), HIVand hepatitis-negative blood donors without history of cancer

Keywords: response study; study; hpv16; test; cancer; drh1

Journal Title: EBioMedicine
Year Published: 2020

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