Human Papillomavirus Portfolio

Validated by independent labs, not just ours

Independent research and clinical pathology groups have published more than 110 papers with Enzo HPV reagents. This is what the results look like.

40

years of HPV innovation

110+

peer-reviewed publications including Nature

22

countries where investigators have published with Enzo HPV reagents

25+

HPV dedicated products across DNA ISH, RNA ISH, IHC and IF platforms

30+

specimen types validated including cervix, head and neck, anogenital, lung, adipose, cell lines

7

automated leading staining platforms validated, plus manual workflows

Cervical tissue stained with AMPIVIEW HPV High-Risk RNA probes; positive nuclei appear dark red.
AMPIVIEW® HPV High-Risk RNA probes

Cervical tissue hybridized with the PATHO-GENE HPV 16/18/31/33/51 probe and developed with HRP-DAB; positive nuclei are brown.
PATHO-GENE® HPV 16/18/31/33/51 probe

Cervical tissue stained with the DIGX HPV 6/11 probe on a Leica BOND III at 40X; positive nuclei are magenta.
DIGX® HPV 6/11 probe

FFPE cervical tissue stained for p16 with ENZ-ABS377; the dysplastic epithelium shows strong brown staining.
p16INK4a monoclonal antibody

Manual 3-plex multiplex staining: HPV 16/18/31/33/51 RNA by in situ hybridization, p16 and Ki-67 protein by immunohistochemistry, with DAPI nuclear counterstain.
3-plex multiplex staining

  • Manual
  • HPV 16/18/31/33/51 RNA (ISH)
  • p16 protein (IHC)
  • Ki-67 protein (IHC)
  • DAPI
Tissue stained with the AMPIVIEW HPV HR-15 RNA probes on a Ventana platform, showing a high-expressing sample with brown and blue signal in many cells.
AMPIVIEW® HPV HR-15 probes

Validated on manual and automated platforms

  • Leica BOND
  • Leica BOND-III
  • Leica BOND-RX
  • Leica BOND-MAX
  • Ventana BenchMark XT
  • Ventana BenchMark ULTRA
  • Ventana UltraView
  • Dako PT Link
  • Dako EnVision
  • Dako Autostainer
  • Manual CSA / CISH
  • Confocal IF

A product × platform × specimen validation matrix with full citations is available to customers on request.

HPV is the most common sexually transmitted infection in the world

Nearly 80% of sexually active people will acquire at least one HPV infection. Most clear on their own. Persistent infection with a high-risk genotype drives cervical, oropharyngeal, anal, vulvar, vaginal and penile cancers, roughly 5% of all cancers worldwide.

~690K

HPV-attributable cancer cases a year (IARC, de Martel 2020)

~83%

of those cancers are cervical, the largest single HPV disease burden

~660K

new cervical cancer cases a year (GLOBOCAN 2022)

~349K

cervical cancer deaths a year (GLOBOCAN 2022)

Pioneers since 1986, still innovating

From the first non-radioactive HPV probe in 1986 to the 15-genotype AMPIVIEW® HR-15 panel in 2025 — Enzo Life Sciences has been pioneering HPV detection since 1986.

“Results with the Enzo probe were so good that we did not continue trying to optimize with a different probe.”

Momin T. Siddiqui, MD, Emory University Hospital · Appl Immunohistochem Mol Morphol 2014

40 years of HPV leadership

1986First non-radioactive HPV DNA probe (PATHO-GENE®).
2004Digene (now Qiagen) offers the most widely used HPV diagnostic test, relying on hybrid capture technology licensed from Enzo.
2018p16INK4a and Ki-67 monoclonal antibodies launched.
2022Enzo launches AMPIVIEW® probes, powered by Enzo’s LoopRNA™ ISH technology.
2023First AMPIVIEW® HPV probes launched.
2025AMPIVIEW® HPV HR-15 DNP (ENZ-GEN320) launched.

Understand how HPV turns a cell cancerous

In most people the viral genome stays episomal and the immune system clears it. In some, it integrates into host DNA, disrupts E2 and lets the E6 and E7 oncoproteins run unchecked.

E7 inactivates pRb, releases E2F and forces S-phase entry. The cell responds by overexpressing p16INK4a, the IHC surrogate marker of E7 activity.

E6 degrades p53 through E6-AP, switching off apoptosis and the DNA-damage response. It also drives c-myc and hTERT, so cells bypass senescence.

Diagram of HPV infection in a cervical cell: viral DNA integration disrupts E2, E6 and E7 inactivate p53 and pRb, driving uncontrolled proliferation, telomere shortening, telomerase activation and immortality, and progression from CIN 1 to invasive cancer.
From viral DNA integration to E6/E7-driven loss of cell cycle control, and the path from CIN 1 to invasive cancer.

E6 recruits E6-AP to degrade p53

ELISA · ISH · IHC

The DNA-damage response fails and genomes destabilize

Functional assays

Cells escape p53-mediated death

Flow · Imaging

Cells bypass replicative senescence and become immortal

Live cell

Stress signals in the tumor microenvironment

Live cell

Mark proliferating cells for grading and efficacy studies

IHC · ISH

Detect with the most complete HPV portfolio

Detect HPV at the DNA level (viral presence and genotype), at the RNA level (transcriptionally active E6/E7) or at the protein level (p16 and Ki-67 markers). Every ISH format comes in more than one hapten, so the probe chemistry matches your detection system, automated platform or multiplex workflow.

Genotype panel DNA · BiotinPATHO-GENE® DNA · DigoxigeninDIGX® RNA · DigoxigeninAMPIVIEW® LoopRNA™ RNA · DNPAMPIVIEW® LoopRNA™
HPV 6/11Low-risk · condyloma ENZ-32885 ENZ-GEN112 ENZ-GEN145 Custom available
HPV 16/18~70% of cervical cancer ENZ-32886 ENZ-GEN113 ENZ-GEN146 Custom available
HPV 31/33/51High-risk · IARC Group 1 ENZ-32887 Custom available ENZ-GEN147 Custom available
HPV 16/18/31/33/515-type high-risk panel ENZ-32882 ENZ-GEN114 ENZ-GEN148 Custom available
HR-15 panelIARC Group 1 + 2A + 2B — ENZ-GEN360 NEW — ENZ-GEN320 NEW
HPV 6/11/16/18/31/33/51Full screening panel ENZ-32884 — Custom available Custom available
Ki-67 (AS)Proliferation marker — — ENZ-GEN271 ENZ-GEN304

Custom probes: 1–2 week delivery through the Enzo custom probe design service.

Researchers moving from screening to functional characterization don’t switch vendors, re-validate protocols or compromise on sensitivity.

PATHO-GENE® typing assaysENZ-32895 Alk Phos / NBT-BCIP · ENZ-32874 HRP-DAB · ENZ-32879 Screening Assay
DIGX® linkersENZ-ABS303 Rabbit anti-Dig · ENZ-ABS304 Mouse anti-Dig
POLYVIEW® PLUS HRP-DABENZ-KIT159 Anti-Rabbit · ENZ-KIT160 Anti-Mouse · nanopolymer, no biotin bridge
New product

Our High Risk 15 Panel covers IARC Group 1, 2A and 2B types

AMPIVIEW® HPV HR-15 (AS) DNP RNA Probes Set · ENZ-GEN320

It covers all 12 Group 1 types, the Group 2A type (68) and Group 2B types 66 and 82, in line with the IARC Monographs (Vol. 90 and 100B) and the WHO 2017 high-risk list.

  • 15 genotypes in a single panel
  • Transcriptionally active E6/E7 at single-cell resolution
  • Detects down to 2–3 target copies per cell
  • Results in about 5 hours
161831333539455152565859686682
IARC Group 1 (12 types) Group 2A Group 2B

The right Enzo tool at every stage of CIN

Cervical intraepithelial neoplasia is graded by how much of the epithelium dysplastic cells occupy, read together with the molecular signature of HPV activity. The lesion advances on its own, stage by stage. Pick a stage to pause on it, or press Auto-play to resume.

Surface Stroma Dysplasia depth
Normal: no dysplasia present.CIN 1: dysplasia reaches the lower third of the epithelium.CIN 2: dysplasia reaches the lower two thirds of the epithelium.CIN 3 / CIS: dysplasia reaches the full thickness of the epithelium.Invasive: dysplasia reaches beyond the basement membrane.

Normal

Healthy cervical epithelium

HPV status
Absent or transient clearance
p16INK4a
Negative
Ki-67
Basal layer only

Reference and control use. Baseline sample for cell cycle, apoptosis and proliferation.

CIN 1

Mild dysplasia · lower ⅓

HPV status
Productive infection (episomal)
Koilocytes
Hallmark feature (perinuclear halo)
p16INK4a
Negative or patchy
Ki-67
Lower ⅓ only

Confirm and genotype HPV. Detect viral DNA and tell low-risk from high-risk types.

CIN 2

Moderate dysplasia · lower ⅔

HPV status
Transition, early integration
E6/E7 mRNA
Rising expression
p16INK4a
Diffuse “block” positive
Ki-67
Suprabasal extension

Confirm transformation. Detect active E6/E7 mRNA alongside surrogate markers.

CIN 3 / CIS

Severe dysplasia · full thickness

HPV status
Integrated, high-risk
E6/E7 mRNA
Strongly overexpressed
p16INK4a
Diffuse block (strong +)
Ki-67
Full-thickness positive

High-risk confirmation. Confirm active oncogenic HPV and grade severity.

Invasive

Carcinoma · basement membrane breach

HPV status
Clonal, integrated
Genomic instability
Chromosomal gains and losses
Telomerase
Activated (E6 → c-myc → hTERT)
Senescence bypass
Immortalization

Research and characterization. Study integration sites, immortalization and host response.

CIN grading: Richart RM, Obstet Gynecol 1990;75:131–3 · WHO Classification of Tumours, Female Genital Tumours, 5th ed. (2020) · LAST Project, Darragh et al., Arch Pathol Lab Med 2012;136:1266–97.

Prevent the reagents behind HPV drugs and vaccines

Prevention now reaches beyond prophylactic vaccination: therapeutic vaccines, HPV-targeted immunotherapies, antivirals and gene-silencing agents. Enzo supplies reagents from target identification and mechanism studies to vaccine development and biologics manufacturing.

Drug discovery

Understand how HPV drives disease, find the right target and confirm that your candidate hits it.

Vaccine and therapeutic development

Characterize HPV antigens and measure the immune response to vaccines and immunotherapies.

Biologics manufacturing

Control the yield, purity and stability of HPV vaccines and HPV-targeted antibodies.

Few vendors can supply the ISH tools to validate target engagement, the antibodies and ELISAs to characterize the immune response, the cell-based kits to assess efficacy and the assays to control biologics quality. Enzo can.

One partner. One portfolio. Four decades of HPV science.

From the first non-radioactive probe in 1986 to the 15-genotype AMPIVIEW® HR-15 panel in 2025.

Ask our HPV Experts