Noul Receives FDA Registration for Cervical Cancer Diagnostic Cartridge
Noul Co., Ltd. has secured FDA registration for its miLab™ Cartridge CER and SafeFix™ CER, essential components of its miLab™ CER cervical cancer diag...
Breakthrough Clinical Results
Noul Co., Ltd. has secured FDA registration for its miLab™ Cartridge CER and SafeFix™ CER, essential components of its miLab™ CER cervical cancer diagnostic solution. This registration allows Noul to enter the U.S. market and initiate commercial shipments in Europe and Latin America, focusing on countries with existing regulatory clearance. The miLab CER system automates cervical cytology using AI for sample preparation, imaging, and analysis. Noul aims to expand its market presence in cervical cancer diagnostics, leveraging its existing miLab platform used for malaria diagnostics and blood analysis.
Key Highlights
- Noul's miLab™ Cartridge CER and SafeFix™ CER receive FDA registration.
- Commercial shipments of miLab CER to begin in Europe and Latin America.
- miLab CER automates cervical cytology with AI-powered system.
- Noul aims to expand its market presence in cervical cancer diagnostics.
Incidence and Prevalence
Global Estimates of Cervical Cancer Incidence and Prevalence
Cervical cancer remains a significant global health concern, ranking as the fourth most common cancer in women worldwide according to multiple recent studies from 2022-2024. Despite the availability of effective HPV vaccines, the disease continues to have a substantial impact on women's health globally.
Global Burden
Current estimates indicate that cervical cancer affects approximately 604,000 women annually and is responsible for 342,000 deaths worldwide each year based on 2023 data. This makes it not only a common cancer but also a leading cause of cancer mortality among women in many regions.
Regional Disparities
The burden of cervical cancer is not distributed equally across different regions:
- In countries with low or moderate levels of human development index, cervical cancer has become the second leading cause of cancer mortality in women (2022)
- In Southwestern Uganda, cervical cancer was found to be the most common cancer among women (10.55% of all cancers) according to 2024 data
- In India, cervical cancer ranks as one of the leading cancers among women and is reported as the most common cancer among women
- During 1990-1997, age-adjusted incidence rates (AAR) for cervical cancer in India varied from 10.9 to 65.4 amongst various registries, with the highest incidence in the Ambillikai registry
- Romania has the highest incidence of cervical cancer in Europe (2011)
- In Ethiopia, cervical cancer is the second most common women's cancer with almost 6300 new cases and 4884 deaths annually (2021)
- In Indonesia, cervical cancer ranked highest (68.6%) among gynecologic cancers (2024)
United States Trends
In the United States, there are notable disparities in cervical cancer rates:
- Cervical cancer incidence plateaued among White women but continued to decline among Black and Hispanic women (2022)
- Following a period of decline, hysterectomy-corrected cervical cancer incidence increased 1.0% per year among Non-Hispanic White women in low-income counties
- A significant 4.4% per year increase in distant-stage cancer occurred in Non-Hispanic White women in low-income counties
- Cervical cancer incidence and mortality rates in Texas are 20% and 32% higher, respectively, than national averages (2024)
- The US South region has both the highest incidence and mortality rates compared to other regions (2017)
Risk Factors
The primary risk factors for cervical cancer include HPV infection, multiparity, early age of marriage, use of cloth during menstruation, early age of first intercourse, and immunodeficiency. Human papillomavirus (HPV) is strongly associated with cervical neoplasia and is the principal cause of the majority of cervical cancer cases.
The global burden of cervical cancer remains significant despite being largely preventable through vaccination and screening, highlighting the need for improved access to these preventive measures, particularly in regions with limited healthcare resources.
Risk Factors and Comorbidities
Top 3 Risk Factors and Comorbidities for Cervical Cancer
1. Human Papillomavirus (HPV) Infection
HPV infection is the central and necessary cause of cervical cancer, though not sufficient on its own. Over 95% of cervical cancer cases worldwide test positive for oncogenic HPV DNA. HPV types are classified into risk groups:
- High risk: types 16 and 18, which have frequent association with cervical cancer and are responsible for 70% of cervical cancer cases
- Middle risk: types 31, 33, and 35
- Low risk: most frequently types 11 and 6
The persistence of HPV infection is considered the most important risk factor for cervical cancer development. The integration of HPV DNA into the host genome is a pivotal event in cervical carcinogenesis, where viral oncoproteins E6 and E7 degrade tumor-suppressor proteins p53 and pRb.
2. Sexual Behavior and Lifestyle Factors
Several behavioral factors significantly increase cervical cancer risk:
- Early-age sexual activities are a significant risk factor
- High number of sexual partners is described as "the most salient risk factor"
- Tobacco smoking functions as an independent risk-factor for cervical neoplasia, with current smokers having an excess risk for squamous cell carcinoma (OR 2.30, 95%CI 1.31-4.04)
- Long-term use of oral contraceptives and other hormonal influences increase risk
- Repeated parity demonstrates an increased risk in HPV-infected women
- Not having cervical smears regularly was rated highly as a risk factor
Research shows smoking increases the risk of cervical cancer among HPV positive women (OR 2.17 95%CI 1.46-3.22), demonstrating how lifestyle factors can compound existing HPV infection risks.
3. Comorbidities and Co-infections
Several comorbid conditions and co-infections are associated with increased cervical cancer risk:
- Epstein-Barr virus (EBV) may play an important role as a cofactor in cervical cancer progression, with 9.8% prevalence in cervical cancer specimens compared to 2.4% in premalignant lesions
- Some studies suggest HPV/HSV-2 coinfection results in a higher risk of developing cervical cancer
- Immunosuppression and alteration of the immune status increase susceptibility
- Diabetes mellitus is associated with cervical cancer incidence in some populations
- Women with cervical cancer have a substantially increased risk of developing other HPV-related cancers, including anal cancer (standardized incidence ratio, 2.20) and oropharyngeal cancer (standardized incidence ratio, 4.36)
- Genetic factors including polymorphism at loci encoding carcinogen-metabolizing enzymes such as cytochrome P450 2D6 (CYP2D6) may determine susceptibility to cervical cancer
The interaction between 17β-estradiol (E2) and HPV infection has been demonstrated to cooperate in cervical carcinogenesis, highlighting the complex interplay between hormonal factors and viral infection.
Recent Studies
Recent Cervical Cancer Studies: Interventions and Outcomes
PRESTIS Trial (2020)
The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial. The intervention involves mailed self-sample HPV testing kits with patient navigation as an implementation strategy. This ongoing study (2020-2024) randomized 2268 participants across three arms to evaluate completion of primary screening as the primary outcome, with secondary outcomes including predictors of screening and attendance for clinical follow-up.
Pembrolizumab Studies (2022)
A meta-analysis of six studies involving 846 patients evaluated pembrolizumab as monotherapy or in combination with chemotherapy. Efficacy outcomes showed extended overall survival by weighted median of 10.35 months and progression-free survival by 8.50 months, with a pooled objective response rate of 22.39%. Patients with high PD-L1 expression (CPS ≥ 10) experienced improved outcomes. Safety outcomes revealed the most common complications were fatigue, diarrhea, and immune-related adverse events.
Immune Checkpoint Inhibitors Meta-Analysis (2024)
This meta-analysis of 12 clinical trials with 523 women diagnosed with advanced cervical cancer evaluated PD-1/PD-L1 and CTLA-4 inhibitors. For PD-1 antibodies, efficacy outcomes included a pooled objective response rate of 24%, complete response rate of 3%, partial response rate of 20%, and stable disease rate of 31%. Safety outcomes showed an adverse events rate of any grade was 81%.
Zimberelimab Study
This phase II study evaluated zimberelimab, an anti-programmed cell death protein-1 antibody, in 105 patients with previously treated, recurrent, metastatic cervical cancer. Efficacy outcomes included an objective response rate of 27.6%, disease control rate of 55.2%, median overall survival of 16.8 months, and median progression-free survival of 3.7 months. Safety outcomes showed the most common treatment-related adverse events were hypothyroidism (26.7%) and anemia (19.0%).
GX-188E Vaccine with Pembrolizumab
A phase II trial tested GX-188E vaccine combined with pembrolizumab for recurrent or advanced HPV-positive cervical cancer. Among 60 patients, efficacy outcomes included a confirmed objective response rate of 35.0%, with 8.3% achieving complete response and 26.7% partial response. Median duration of response was 12.3 months, median progression-free survival was 4.4 months, and median overall survival was 23.8 months. Safety outcomes showed 33.8% of patients had treatment-related adverse events, with 6.2% experiencing grade 3-4 events.
Apatinib Study (2023)
This study evaluated apatinib combined with chemotherapy and concurrent chemo-brachytherapy in patients with recurrent and advanced cervical cancer. Safety outcomes showed proteinuria, hand-foot syndrome, mucositis, and hypertension were statistically more common in the apatinib group than in the control group, though apatinib did not obviously aggravate other radiotherapy or chemotherapy side effects. The study concluded that apatinib exhibited promising clinical efficacy with manageable side effects.
