Package No. 151 – is the most comprehensive cervical screening option, designed to ensure maximum accuracy and reliability of results. It not only helps detect precancerous cervical changes but also assesses their potential risk, helping to avoid unnecessary invasive procedures.
The package includes: Pap test using BD SurePath™ liquid-based cytology with automated BD FocalPoint™ analysis (Cytology Passport) – a modern technology for early detection of precancerous and malignant changes.
At Synevo, this test is performed using a dual-review approach:
- by experienced cytologists;
- using the BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) with the ZEISS Axioscope 5 microscope (Carl Zeiss, Germany).
This combination significantly improves the sensitivity and reliability of detecting abnormal cells at the earliest stages when treatment is most effective. PCR test for high-risk HPV (14 genotypes, quantitative analysis) – a method that detects HPV infection, identifies specific genotypes, and determines viral load. This is especially important since types 16 and 18 account for over 70% of cervical cancer cases. p16 and Ki-67 markers – specific biomarkers that help distinguish transient (temporary) changes from clinically significant precancerous lesions (CIN2+). Using these markers reduces the number of unnecessary biopsies and allows physicians to more accurately assess the risk of disease progression.
Learn more about the technology and the Cytological Passport.
BD SurePath™ is a modern liquid-based cytology method recommended by the FDA (USA) and CE directives. It provides maximum cell preservation through fixation in a liquid medium, producing a clean and uniform sample free from mucus, blood, and inflammatory cells, and creating a 13 mm monolayer of cells that is ideal for microscopic analysis.
Advantages of BD SurePath™ compared to conventional cytology:
- +107% – detection of LSIL (low-grade squamous intraepithelial lesion);
- +64.4% – detection of HSIL (moderate and severe dysplasia);
- -58% – reduction in the number of unsatisfactory samples requiring repeat collection;
- +75% – improved differentiation between inflammation and atypical cells of the ASC-US type.
Co-testing capability – allows simultaneous HPV and Pap testing from a single specimen.
BD FocalPoint™ – an artificial intelligence-based imaging system (Cytology Passport). Cytology preparations made using BD SurePath™ technology are additionally analyzed with the BD FocalPoint™ GS Imaging System.
The test result is generated based on a dual-expertise approach, combining the experience of a cytology expert with AI-assisted microscopy.
The analysis is performed using the modern BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) in combination with the high-tech ZEISS Axioscope 5 microscope (Carl Zeiss, Germany). This innovative, high-precision automated technology ensures rapid and effective detection of potentially abnormal cells in cytology samples, making the results highly reliable and reproducible.
The BD FocalPoint™ methodology (Becton Dickinson, USA) is officially approved by the FDA (USA) for routine use in cervical cancer screening, detection of precancerous lesions, and atypical cells, based on Pap smear analysis using the BD SurePath™ liquid-based cytology technology (Becton Dickinson, USA).
The BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) statistically significantly increases the sensitivity of detecting cervical cancer and precancerous lesions compared with traditional approaches, namely:
- 9.2% increase in detection of ASC-H (Atypical squamous cells cannot exclude HSIL – atypical cells that may indicate severe precancerous changes);
- 9.8% increase in detection of LSIL+ (Low-grade squamous intraepithelial lesion – low-grade intraepithelial lesion of squamous epithelium);
- 19.6% increase in detection of HSIL (High-grade squamous intraepithelial lesion – high-grade intraepithelial lesion of squamous epithelium);
- 24.5% increase in detection of cervical cancer.
The analysis complies with the Order of the Ministry of Health of Ukraine No. 1057 dated 18.06.2024, “Standard of Medical Care. Cervical Cancer Screening. Management of Patients with Abnormal Screening Results and Precancerous Cervical Conditions.”
Each result is accompanied by automated individual digital images created and processed by the BD FocalPoint™ GS Imaging System, which visualize diagnostic areas containing significant cytological cells and are evaluated according to the Bethesda System (2014) classification.
PCR test for high-risk HPV (14 genotypes, quantitative determination)
Human papillomavirus (HPV) is the main cause of cervical cancer. The most dangerous are considered the high-risk genotypes (16, 18, and 12 additional types).
The quantitative PCR method allows to:
- determine the presence of HPV DNA in the sample;
- identify exactly 14 high-risk genotypes;
- assess the viral load, which helps distinguish a transient infection from a persistent one (which has a high risk of progression to precancerous lesions).
Markers p16 and Ki-67
These are modern immunohistochemical markers that help assess the biological activity of HPV infection and the risk of developing precancerous lesions:
p16 – a tumor suppressor protein, the level of which increases sharply when high-risk HPV DNA integrates into epithelial cells. Strong p16 expression indicates a high risk of HSIL and CIN2+.
Ki-67 – a proliferation marker that identifies cell division. Its expression together with p16 indicates active pathological processes and a high probability of lesion progression.
Advantages of determining p16 and Ki-67:
- increases diagnostic accuracy for ASC-US, ASC-H, and LSIL;
- helps avoid unnecessary biopsies in cases of ambiguous cytological results;
- enables risk stratification – the clinician receives a clearer prognosis of CIN2+ risk;
- officially recommended by ASCCP and ESGO as an auxiliary tool for screening and patient management.
Advantages of combining cytology, PCR HPV high-risk testing, and p16/Ki-67 markers:
- Comprehensive assessment – simultaneous analysis of cellular morphology (Pap test), presence and quantity of HPV (PCR), and biological activity of the infection (p16/Ki-67).
- Higher accuracy – reduction in false-negative and equivocal results, particularly in ASC-US, ASC-H, and LSIL cases.
- Avoiding unnecessary biopsies – p16/Ki-67 markers help minimize invasive procedures when cytology results are unclear.
- International standards – consistent with ASCCP, ESGO, WHO recommendations and the Order of the Ministry of Health of Ukraine No. 1057.
- Personalized approach – provides the most complete information to determine optimal monitoring or treatment strategy.
