The Art of Accuracy
In vitro diagnostics (IVD) requires accuracy, reliability,
and precision. At Fujirebio, we aim at raising human
papillomavirus (HPV) testing to an art form that can
impact the lives of millions around the world.
We now also offer methylation technology.
Since our founding in 1950 we have developed and
provided trusted and innovative IVD testing solutions that
empower healthcare professionals with accurate insights
that allows – for the most clinically dependable outcomes
of patients – outcomes that affect their future.
Since the 1990’s our molecular testing solutions have been
recognized for their high quality. We have recently extended
our molecular testing portfolio and are now pleased to also
offer methylation testing technology. Methylation testing
raises accuracy and reliability to an art form that can make
a decisive difference in the lives of millions of patients
across the world.
Our reliable and accurate solutions for molecular
test laboratories today include:
• Hepatitis B virus • Sexually transmitted
• Hepatitis C virus infections
• Human papillomavirus • Urinary tract
• Mycobacteria infections
Our portfolio of HPV testing solutions eases the burden
on clinicians and patients, through improved screening,
accurate triage, and identification of high-risk patients
in need of treatment and through precise genotyping,
when needed.
HPV and the challenge
of screening programs
With millions of men and women globally infected
with HPV, it is one of the most common –
sexually transmitted infections.1 Elimination of
all HPV-related cancers would not only remove
cervical cancer but also anogenital and
oropharyngeal cancers which are an increasing
global health burden.2
Global efforts to eliminate cervical cancer focus
on expanding coverage of HPV vaccination and
improving cervical cancer screening. However,
within (primary HPV) screening programs it is not
possible to clearly distinguish within the positively
tested women, those who have persistent and
progressing cervical disease and those, for whom
the disease might be regressing, leading to higher
referrals to colposcopy.3
Methylation-specific molecular assays have been
demonstrated as a sensitive follow-up test to
identify HPV positive women with progressing
cervical disease in direct need for colposcopy
or other follow-up procedures.4,5
 Effective and accurate solutions for screening,
triage and genotyping
PreCursor-M+ (CE-IVD marked) Triage

Leading the future of diagnostic testing for the risk of cervical cancer in high-risk human
papillomavirus (hrHPV) positive women is the PreCursor-M+ assay, developed by Self-screen.
This innovative methylation-specific PCR assay is the most clinically validated, standardized
and commercially available assay on the market, supported by high-quality validation studies.

INNO-LiPA HPV Genotyping Extra II (CE-IVD marked) Genotyping

Developed by Fujirebio, the INNO-LiPA HPV Genotyping assay is a trusted and renowned
name in HPV genotyping for almost 20 years. This highly sensitive assay provides full
genotyping information, even on difficult sample matrix, for example, formalin-fixed
paraffin-embedded tissue samples.

AmpFire HPV High Risk Genotyping (CE-IVD marked) Genotyping

Using optimized isothermal amplification technology with real-time fluorescence detection, the AmpFire HPV High Risk
Genotyping assay from Atila Biosystems offers time and cost-saving testing and diagnosis to the HPV testing portfolio.
This molecular assay does not require highly skilled expert technicians or expensive equipment.

HPV-Risk assay (CE-IVD marked) Screening

The HPV-Risk assay from Self-screen is clinically validated and has a reputation for reliability, especially when it comes
to avoiding false-negative results caused by viral DNA integration during cancer development.

AmpFire HPV Screening 16/18/HR (CE-IVD marked) Screening

Fujirebio also provides the Atila Biosystems AmpFire HPV Screening 16/18/HR assay, capable of detecting 14 high-risk
HPV types with simultaneous HPV16 and HPV18 genotyping.

For more information and ordering details about our products and automation solutions, please contact
your Fujirebio representative.

Your molecular biology testing partner.

Our strong partnerships with customers and with innovative diagnostic companies makes us a trusted provider of fast,
accurate, clinically validated molecular biology diagnostic solutions across the globe.
We are an R&D-driven company, which gives us the power to explore, discover, and partner in order to deliver solutions
at the forefront of early diagnostics.

References:
1. Kombe Kombe AJ et al. (2021) Epidemiology and Burden of Human Papillomavirus and 4. Kremer WW et al. The use of host cell DNA methylation analysis in the detection and
Related Diseases, Molecular Pathogenesis, and Vaccine Evaluation. Front. Public Health management of women with advanced cervical intraepithelial neoplasia: a review.
8:552028. doi: 10.3389/fpubh.2020.552028 BJOG 2021;128:504-514
2. Forman D. et al. Global burden of human papillomavirus and related diseases. Vaccine. 5. Bonde J. et al. Int. J. Cancer. 2021;148:396-405. Methylation markers FAM19A4 and
2012 Nov 20;30 Suppl 5:F12-23. doi: 10.1016/j.vaccine.2012.07.055. miR124-2 as triage strategy for primary human papillomavirus screen positive women:
3. Vink FJ et al. Classification of high-grade cervical intraepithelial neoplasia by p16ink4a, A large European multicenter study.
Ki-67, HPV E4 and FAM19A4/miR124-2 methylation status demonstrates considerable
heterogeneity with potential consequences for management. Int. J. Cancer. 2021; 149:
707– 716. https://doi.org/10.1002/ijc.33566
© Fujirebio Europe, February 2023, FRE-293

PreCursor-M+ is a registered trademark of the legal manufacturer, Self-screen B.V., the Netherlands, and is distributed by Fujirebio Europe. AmpFire is a registered trademark
of Atila Biosystems Ltd., Thinprep is a registered trademark of Hologic Inc., Surepath is a registered trademark of Becton, Dickinson and Company.

Visit www.fujirebio.com/hpv
for more information.