HPV PRO

What is HPV PRO?

HPV PRO is the first HPV Hub & Spoke HPV diagnostic service for physicians.

With HPV PRO every physician can collect the biological samples at his location and send them to our regional lab for the analysis.

Swab samples are conducted by physicians during the routine visit. These samples are then taken to one of our European network of laboratories to be analysed.

Gynaecologists and physicians can get directly to their offices the result of the real-time PCR test with full genotyping.

Get your result in 3 days from receipt of samples directly to your office

Why HPV PRO?

HPV DNA tests should provide maximum information (genotype, co-infection, quantitative result) about the infection to facilitate the clinical follow up of the patient. HPV PRO, thanks to Ulisse Biomed’s SAGITTA patented technology is able to detect and provide single genotyping of up to 30 HPVs, correlated to cervical cancer or condylomas.

HPV PRO key features

Single genotyping of 14 HR-HPV subtypes in order to:
- Track persistent infections of HR-HPV types
- Monitor HR-HPV co-infections
- Optimise screening and triage practices
Possibility to extend the diagnosis up to 30 HPV types with our add-ons
• Multiplex real-time PCR for reliable results by utilization of Sagitta™ patented technology
Validated for screening purposes (Meijer’s Guidelines)
Validated with self-collection devices (VALHUDES Protocol)
High sensitivity and specificity
Smooth work-flow and greater diagnostic information
Great value for money

OUR SERVICES

HPV PRO 14 HR | 14 high-risk HPVs

There are more than 120 different types of Human Papillomavirus (HPV) types, or genotypes, are grouped according their oncogenic capability: low-risk and high-risk HPVs.

HPV PRO is a screening test including single genotyping of the 14 high-risk HPV strains identified by IARC as the most dangerous and widespread.

These strains (HPV16, 18, 31, 33, 35, 39, 45, 51,52, 56, 58, 59, 66 and 68) are linked to the onset of cervical cancer, as well as to many other cancers of the uterus, anogenital area (vaginal tumors, penile tumors, vulva tumors, anal tumors, etc.) as well as oropharyngeal tumors. Persistent infection by high-risk HPV genotypes can increase a woman’s risk of forming pre-cancers, which can develop into cervical cancer and other types of genital cancers-such as vulvaror anal – if the body it is unable to clear the infection on its own. Information on HPV positivity can provide a more complete picture of cervical cancer risk or make important decisions about further testing and patient-specific prevention.

Furthermore, unlike the more common screening tests, HPV PRO also provides the exact genotypeof the HPV present in the biological sample.

This information is valuable as:

Knowledge of the HPV genotype is useful in clinical decision making for the management of HPV positive women. According to the most recent studies, in fact, some strains such as HPV 16,HPV18, HPV31 and HPV33 may require more intensive follow-up than other types
Monitoring the persistence of the same HPV type over time by genotyping the single strain could help prevent the development of persistence-related lesions of a single HPV type
The presence of co-infections from multiple strains is an additional risk factor

HPV PRO 5 pHR | 5 probable high risk HPVs

HPV PRO 5 pHRadd-on service detects and distinguishes the genotypes of HPV 26, 53, 66, 67, 68,70, 73 and 82, which are currently classified as probable/possible carcinogens (IARC Groups 2Aand 2B), for the combination of their low frequency and the scarcity of data on their transformation potential; however, their oncogenicity has been confirmed in several studies.

Through this additional analysis, it is therefore possible to have extensive and complete information on all strains considered to be oncogenic, including those that are not detected by the screening tests. In some cases, in fact, cases of cervical cancer negative for the HPV screening test but positive for HPV strains at probable high risk have been identified.

In addition to being valuable information for the patient, genotyping of probable high-risk HPVs can provide further evidence on the oncogenicity of these subtypes and enrich scientific knowledge on their frequency and the associated risk of developing cervical cancer

HPVPRO 11 LR | 11 low-risk HPVs

The HPV PRO 11 LR add-on service specifically detects and simultaneously genotypes the most popular 11 low-risk HPV strains (HPV6, 11, 40, 42, 43, 44, 54, 61, 70, 81, 84).

Low-risk HPVs are the etiological cause of anogenital warts, the most common sexually transmitted disease, affecting millions of people worldwide every year. HPV6 and 11 predominate in the pathogenesis of the common anogenital wart, or condyloma acuminatum. Genital warts can cause extensive papillomatosis in predisposed individuals with an increased risk of tumor development. Additionally, low-risk HPV types are responsible for more than 90% of laryngeal condylomatosis cases in children.

HPV PRO Premium | 30 HPV types

This analysis offers the comprehensive detection and genotyping of the most common HPV strains of the anogenital area, offering an extensive analysis that allows information ongeno types with a probable high risk of tumor development and low-risk genotypes associated with warts.

Low-risk viral genotypes have a low degree of association with malignant lesions, while genotypes with high and probable high oncogenic risk present a significant risk of pretumor transformation. Together with HPV PRO 14HR, the doctor will thus be able to verify the presence of 30 HPV genotypes and have a complete overview of the strain (s) present in the patient and therefore to evaluate the probability of a neoplastic evolution, whether benign or malignant, to depending on any HPV genotype present.

High sensitivity and specificity
Possibility of genotyping single infections or co-infections of different strains
30 genotypes: 14 high-risk genotypes
(HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and68) + 5 probable high-risk HPV genotypes (HPV26 , 53, 69, 73, 82) + 11 low-risk HPV (HPV6, 11, 40,42, 43, 44, 54, 61, 70, 81, 84)