4277. Package #129 (Cervical screening: PAP test using liquid cytology (BD SurePath technology, FDA approved). CYTOLOGICAL PASSPORT (BD FocalPoint technology, FDA approved), PCR. HPV HCR 14 genotypes, quantitative determination)

Package No. 129 combines two modern methods of cervical screening that allow for the most accurate assessment of cervical health: Pap test using the BD SurePath™ liquid-based cytology method with additional automated analysis via BD FocalPoint™ (Cytology Passport) – a state-of-the-art, high-precision technology for early detection of precancerous and malignant cervical changes.

At Synevo, the study is performed using a dual-review approach:

• by experienced cytologists;
  
• using the BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) based on artificial intelligence, combined with a ZEISS Axioscope 5 microscope (Carl Zeiss, Germany).
  

This approach significantly increases the sensitivity and reliability of detecting pathological changes. The test allows the identification of epithelial cells showing signs of precancerous or malignant transformation at early stages, when treatment is most effective. PCR test for high-risk human papillomavirus (HPV) (14 genotypes) with quantitative determination – a modern method that detects HPV infection and measures viral load for the most oncogenic genotypes associated with cervical cancer. The combined approach makes it possible to simultaneously assess the morphological changes in cervical cells and detect high-risk HPV infection, thereby increasing diagnostic accuracy in line with current international standards (ASCCP, ESGO, WHO) and the Order of the Ministry of Health of Ukraine No. 1057 dated 18.06.2024.

In Ukraine, cervical cancer ranks among the top three most common cancers in women, which makes regular screening crucial for prevention and maintaining women’s health.

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 preservation of cells due to fixation in a liquid medium, a clean and uniform sample free from mucus, blood, and inflammatory cells, and the creation of a monolayer of cells with a diameter of 13 mm  – ideal for microscopic analysis.

Advantages of BD SurePath™ compared to conventional cytology:

Co-testing capability – allows simultaneous HPV testing 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 using the BD FocalPoint™ GS Imaging System. The test result is generated based on a dual-expertise approach, which combines the experience of a laboratory cytology expert with the capabilities of AI-based microscopy. The analysis is performed using the modern BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) in combination with the high-precision ZEISS Axioscope 5 microscope (Carl Zeiss, Germany). This innovative, high-accuracy automated technology ensures rapid and efficient detection of potentially abnormal cells in cytological 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 analysis of cervical smears via Pap testing using 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 to traditional approaches, namely:

The analysis complies with the Order of the Ministry of Health of Ukraine dated 18.06.2024, No. 1057, “Standard of Medical Care. Cervical Cancer Screening. Management of Patients with Abnormal Screening Results and Precancerous Cervical Conditions.”

Each result additionally includes automated individual digital images, created and processed by the BD FocalPoint™ GS Imaging System, which visualize diagnostic fields containing significant cytological findings, followed by evaluation 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:

Advantages of combining cytology and PCR HPV high-risk testing:

• routine screening for women;
  
• after a positive HPV test or abnormal cytology results;
  
• after CIN treatment or conization to monitor treatment effectiveness;
  
• in cases of detected dysplasia, inflammatory changes, or STIs;
  
• to assess the risk of progression in persistent HPV infection.
  

• Site-specific scrapings collected depending on the test
• Scrapes from various sites depending on the test