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The Digital Cervical Cell Analysis Solution, miLab™ CER

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The digital cervical cell analysis solution miLab™ CER, can replace the complex process of staining, washing, and drying smeared cervical cell slides and the infrastructure required in one device. By analyzing the cervical cell images taken by the device with AI algorithms, experts can quickly and conveniently identify the stage of cervical pre-cancer/cancer in women. Medical experts can examine the results of miLab™ CER either on-site or remotely. Based on the results, experts can quickly and accurately determine the need for on-site treatment or advanced hospital referral.

miLab™ CER focuses on improving access to healthcare for women in settings where early detection of cervical cancer is difficult.

Cervical cancer is the fourth most common cancer in women worldwide and it is preventable with early screening. However, many women are unable to access early cervical cancer screening due to a lack of diagnostic testing infrastructure and specialized experts. The WHO has set a goal to reduce cervical cancer incidence by 42% by 2045 when compared to 2020, and has asked the international community for active and supportive participation.

Current Status of Cervical Cancer Worldwide

* Year 2021

  • Annual number of cervical cancer cases worldwide ('20)
    600,000
  • Percentage of women have been screened for cervical cancer in the past 5 years, high-income countries vs. low and middle-income countries
    74% vs 9%
  • The percentage of deaths from cervical cancer cases worldwide per year ('20)
    58%
  • The age at which human papillomavirus (HPV) infection, which causes cervical cancer, starts being transmitted
    15 year old
  • The proportion of low and middle-income countries in the number of cases of cervical cancer
    90%

Pap smear tests and HPV tests are typical cervical cancer diagnostic methods. Despite their advantages, these traditional diagnostic tests have many limitations in terms of infrastructure, operational costs, and reliability of results.

Current Technical Limitations of Cervical Cancer Diagnosis

Absolute lack of diagnostic infrastructure and experts
  • In low and middle-income countries, there need to be more experts who can accurately read the results.
  • African countries have an average pathologist-to-population ratio of less than 1 per every million, 1/50 of the United States.
  • Even in high-income countries such as Canada, the shortage of experts is increasing.
High complexity of workflows
  • Papanicolaou staining for cervical cytology consists of 7 types of reagents and 20 detailed work steps, so the proficiency of an expert is essential.
  • The possibility of human error depends on the test environment and experts.
High diagnostic testing cost and required time
  • Time required for diagnostic test: At least 2 - 60+ days.
  • High workflow costs due to experts, infrastructure,equipment, etc. for accurate diagnosis.
A test method capable of early diagnosis is absent in low and middle-income countries
  • Difficult to establish a diagnostic laboratory for Pap Smear testing due to resource constraints in low and middle-income countries, which account for 90% of cervical cancer cases.
  • Problems with excessive treatment due to HPV tests that cannot quantify the stage of cervical cancer.

Full Process Automation Including Standard Staining, Gathering Digital Imaging, and AI Analysis

Innovative solid staining technology enables standard Pap Smear methods automation
  • Replace diagnostic laboratory functionality in one device without additional infrastructure investment.
  • Provide Pre-classification of precancerous/cancerous cells based on AI analysis.
Dramatic improvements of existing workflows
  • Dramatically simplifies and automates the Papanicolaou staining process from 20 to 5 steps.
  • Fully automated imaging and sample prep processes including staining, cleaning, drying, etc.
Supports same-day diagnosis and remote diagnostic service
  • Test results can be checked in an hour directly at the collection site, allowing for rapid clinical response according to the test results.
  • Store digital images as records and support remote diagnosis services.
Provides reliable early diagnostic tests in low and middle-income countries
  • Implement reliable Pap Smear test in resource-constrained environments.
  • Prevent over-treatment by providing a clear basis for determining lesions in the field based on the morphological characteristics of cervical cells.

miLab™ CER Enables Medical Institutions to Collect Samples to Perform Cervical Cancer Screening In-house.

1. Medical Institutions That Want to Perform Pap Smear Tests In-house
Target customer
Medical institutions that are capable of collecting cervical cells, but are not capable of performing Pap smear tests in-house in a country where the primary cervical cancer screening method is a Pap smear.
Expected Value
Expand revenue generation opportunities with additional Pap smear tests.
Background
Many countries, including the Republic of Korea, operate cervical cancer screening as a state-funded program, and many medical institutions in each country participate in cervical cancer screening programs. However, only a few medical institutions have diagnostic laboratories. Most medical institutions conduct tests by collecting cervical cells and entrusting them to a nearby professional diagnostic laboratory.
Problem
Medical institutions unable to perform in-house Pap smear tests must ship samples to an external diagnostic laboratory and pay for the tests. Depending on the examination schedule of the external diagnostic laboratory, it usually takes about 7 to 60 days or more to receive the results.
Use-Case
The introduction of miLab™ CER enables those medical institutions capable of collecting cervical cells to perform cervical cancer screening tests with the addition of simple work steps. Since miLab™ CER is a solution that automates the process of sample staining, digital imaging, and AI analysis, medical institutions just need to add the process of smearing and fixing the collected cervical cells on the slide.
Benefits
With the introduction of miLab™ CER, medical institutions can share screening results more quickly with patients who come for cervical cancer screening. They can expand their revenue generation opportunities by providing additional tests that they could not previously perform.
2. Medical Institutions That Want to Improve the Productivity of Pap Smear Tests
Target customer
Medical institutions performing Pap smear tests in a labor-intensive manner.
Expected Value
Improve workflow and productivity with the automation of Pap smear tests.
Background
A typical Pap smear test is usually a labor-intensive procedure. The sample preparation consists of manual blood smear, fixation, staining, washing, and drying, and then experts check the shape and distribution of cervical cells one by one through a microscope. Papanicolaou staining is, in particular, quite complicated with 20 steps of tasks.
Problem
Due to the labor-intensive method, the greater the number of Pap smear tests, the higher the level of physical fatigue felt by experts, and the higher the possibility of human error. It is difficult to perform more tests maintaining employee and time constraints because each medical institution has fixed working standards for Pap smear tests.
Use-Case
Medical institutions looking to improve the productivity of Pap smear tests can use miLab™ CER to automate some parts of experts’ tasks. miLab™ CER automates the most complicated and error-prone Papanicolaou dyeing, digital imaging, and AI analysis processes. Experts can focus on reviewing and finalizing the AI-analyzed results on the monitor screen without taking care of complicated staining or locating cervical cells one by one. While experts are away, other staff members can work with miLab™ CER. When experts come back to work, they can review and finalize the pre-analyzed results stored in the database.
Benefits
Medical institutions using miLab™ CER can perform more tests than those using traditional processes given the same number of people and time. Medical institutions can respond to the growing demand for tests by introducing miLab™ CER without hiring more experts. Higher productivity is more valuable in high-income countries where labor costs are high.
3. Medical Institutions That Want to Improve the Accuracy of Pap Smear Tests
Target customer
Medical institutions that have their own diagnostic laboratories but conduct Pap smear tests with low-skilled experts.
Expected Value
Enhancing quality assurance and quality management systems to improve the reliability of Pap smear tests.
Background
Typically, experts performing Pap smear testing require specialized knowledge and experience. In addition to completing professional education above the university and passing the national qualification exam, practical education and training are also required. In countries with well-equipped medical education facilities and systems such as the Republic of Korea, the level of experts is maintained. However, in low and middle-income countries, medical education facilities and systems are insufficient.
Problem
Because the Pap smear test is carried out in a labor-intensive manner, the analysis and judgment results vary depending on the proficiency of the expert. Incorrect analysis results from the Pap smear test lead to incorrect diagnosis and treatment of the patient. Healthcare organizations can compare the results by having multiple experts perform tests simultaneously to ensure that the results are accurate, or have a proven expert verify the results. However, all of these methods incur additional cost burdens, such as hiring highly qualified personnel.
Use-Case
For healthcare organizations that want to improve the accuracy of Pap smear testing, miLab™ CER can be included in their quality control system. miLab™ CER standardized Pap smear's core processes from Papanicolaou staining to AI analysis. Therefore, the reliability of experts can be confirmed by comparing the results of the Pap smear test with the results of the miLab™ CER. In addition, digital data generated by miLab™ CER can be used for education and training materials for low-skilled experts.
Benefits
For healthcare organizations that want to improve the accuracy of Pap smear testing, miLab™ CER can be included in their quality control system. miLab™ CER standardized Pap smear's core processes from Papanicolaou staining to AI analysis. Therefore, the reliability of experts can be confirmed by comparing the results of the Pap smear test with the results of the miLab™ CER. In addition, digital data generated by miLab™ CER can be used for education and training materials for low-skilled experts.
4. Medical Institutions That Want to Perform the Remote Pap Smear Tests
Target customer
Medical institutions that are capable of collecting cervical cells without their own diagnostic laboratory, however, don't have higher-level hospitals with experts nearby to ask for consignment examinations.
Expected Value
Improving medical access for patients marginalized from the existing medical system.
Background
In remote and mountainous regions where physical access is not easy or in low and middle-income countries where specialized educational facilities are scarce, there are not enough experts to conduct Pap smear tests. In some areas, there are no medical institutions capable of performing the Pap smear tests.
Problem
Residents living in such areas, where it is difficult to take the Pap smear test, have the inconvenience of traveling a long distance to get a cervical cancer screening test. Due to this inconvenience, they may not receive regular cervical cancer screening tests, which leads to being exposed to the risk of disease.
Use-Case
Medical institutions capable of collecting cervical cells in such areas can share digital data to ask remote experts for precise readings.
Benefits
With the introduction of miLab™ CER, those medical institutions can improve residents' access to cervical cancer screening to help residents diagnose cervical cancer early and receive appropriate and timely treatment.
5. The Government That Wants to Switch to a More Reliable Cervical Cancer Screening System
Target customer
The government of low and middle-income countries where the number of cervical cancer cases and deaths are serious but rely on VIA tests as cervical cancer screening methods due to a lack of national diagnostic laboratory infrastructure and experts.
Expected Value
Establishing a reliable basis for early screening of cervical cancer to reduce the number of cervical cancer cases and deaths in the country while minimizing investment in infrastructure and experts.
Background
A Pap smear is the most common and accurate screening method for cervical cancer, but it has limitations in diagnostic laboratory infrastructure and reliance on experts. More than 50 low and middle-income countries worldwide use the VIA method as a screening method for cervical cancer due to lack of resources, or do not specify a screening method at the government level.
Problem
The VIA method is non-scientific since it depends on the visual checking of inspectors. The WHO does not recommend this screening method due to low accuracy and concerns over subjective judgment by inspectors. In countries that use the VIA method for cervical cancer screening, it is difficult to accurately determine the patient's condition, making it difficult to achieve early diagnosis and early treatment of cervical cancer.
Use-Case
Governments that rely on VIA methods or do not specify a method for cervical cancer screening can use miLab™ CER to designate the Pap smear tests as the national standard for cervical cancer screening. miLab™ CER minimizes medical institutions' investment in diagnostic laboratory infrastructure to perform Pap Smear tests, and can establish a cervical cancer screening system that can best utilize a small number of experts by improving workflows and providing remote diagnostic services. By providing a wealth of materials for educating and training experts based on accumulated digital data, introducing miLab™ CER can contribute to fostering experts in the country.
Benefits
With the introduction of miLab™ CER, these countries will be able to shift their cervical cancer screening methods to the most common and reliable Pap Smear tests with minimal diagnostic laboratory infrastructure and expert investment. This allows people to accurately diagnose cervical cancer early and establish a public health system that can receive appropriate treatment.
6. Other Cases
miLab™ CER is a widely applicable solution for various environments and situations. Do not hesitate to contact us anytime if you are interested in using miLab™ CER products. With Noul you can create a healthcare environment supporting women in early and regular cervical cancer screening; improving health and saving lives.
CER

Stain, Scan, and
Classify cells in 20 mins

miLab™ CER Specification
Sample Preparation
Sample typeCervicovaginal sample collected via LBC or manually
Staining typePapanicolaou staining with NGSI
Imaging
Lens20x
Focusz-stack focus images (10 layers)
ImagingAutomatically detects and reviews around 800 field images
Analysis
Classification NILM, ASCUS, LSIL, ASC-H, HSIL, SCC
ImagesField images classified according to the Bethesda system
Total Test Time
Avg. 15 mins
Remote Review
Viewing FunctionsAI classification, Field images, Reclassification and Report