The FDA-approved molecular testing platforms for HPV have been reviewed in detail ¹ and compared by genotype coverage ². Interestingly, even the most comprehensive of these tests provides just 9 result groups, of which only 6 are distinct genotypes ³. The remaining assays provide at most 2 genotypes, or even no genotyping data at all ^4-7.

In contrast, the DiagCor Life Science GenoFlow^TM HPV Array Test Kit (CE-IVD) not only covers the same 6 discrete highest risk genotypes and improves the resolution of the other 8 high risk (HR) types, but also identifies 9 additional unique HR types and 6 unique low risk (LR) types, giving a total of 33 genotypes across 27 result groups ⁸. This makes the GenoFlow^TM HPV Array Test Kit the assay of choice for extended genotyping in non-US markets.

Based on publicly available WHO HPV LabNet Proficiency program data, the GenoFlow^TM HPV Array also performs better, with all datasets achieving 100% proficiency (and therefore no false positive results) in 2019 ⁹ and 2021 ¹⁰. In comparison, the most comprehensive FDA-approved assay achieved 100% proficiency in only 50% of its datasets in both years (and in 2019, 50% of their data sets were in fact "not proficient" and had one or more false positive genotype results ⁹). One of the FDA-approved platforms performed even worse, with all data sets "not proficient" and with false positive results ⁹.

Please get in touch if you would like to learn more about DiagCor Life Science's comprehensive HPV portfolio.

References

¹ Salazar KL, Duhon DJ, Olsen R, Thrall M. A review of the FDA-approved molecular testing platforms for human papillomavirus (2019). J Am Soc Cytopathol. 8(5):284-292.
² https://womens-health-solutions.bd.com/cervical-cancer/extended-genotyping/fda-approved-hpv-assays
³ https://womens-health-solutions.bd.com/cervical-cancer/bd-onclarity-hpv-assay/the-most-comprehensive-hpv-test-results-you-can-get
⁴ https://www.hologic.com/sites/default/files/package-insert/15-3100_105_01.pdf
⁵ https://www.qiagen.com/us/products/diagnostics-and-clinical-research/sexual-reproductive-health/cervical-cancer-screening/digene-hc2-hpv-dna-test
⁶ https://diagnostics.roche.com/global/en/products/params/cobas-hpv.html
⁷ https://www.hologic.com/sites/default/files/package-insert/AW-14517-001_003_01.pdf 
⁸ https://diagcorlifescience.com/en/mdx-products/detail/hpv-array-test-kit
⁹ Eklund C, Mühr LSA, Lagheden C, Forslund O, Robertsson KD, Dillner J. The 2019 HPV Labnet international proficiency study: Need of global Human Papillomavirus Proficiency Testing (2021). J Clin Virol. 141:104902.
¹⁰ Arroyo Mühr LS, Eklund C, Lagheden C, Forslund O, Robertsson KD, Dillner J. Improving human papillomavirus (HPV) testing in the cervical cancer elimination era: The 2021 HPV LabNet international proficiency study (2022). J Clin Virol. 154:105237.