Cervical cancer remains a major health crisis in Indonesia, where it stands as the second most common cancer after breast cancer. According to statistics from the Global Burden of Cancer Study (Globocan), Indonesia witnessed 36,633 new cases and 21,003 deaths in 2020 alone, translating to approximately 50 new diagnoses daily and over two fatalities every hour. These harrowing numbers serve as a stark reminder, especially when considering that cervical cancer is largely preventable and, if caught early, treatable. The urgency behind these statistics is further intensified by the relatively low uptake of screening programs in the country—a concerning trend mirrored worldwide, especially in low- and middle-income nations.
Early Detection: The Promise and Pitfalls of Current Practices
Cervical cancer prevention and early detection hinge on two main strategies: vaccination against the human papillomavirus (HPV) and widespread, effective screening. While HPV vaccination blocks one of the root causes of this disease, effective screening allows lesions and abnormal cell changes to be caught before they advance into full-blown cancer. Common screening methods include visual inspection with acetic acid (VIA), Pap smears, and, increasingly, the molecular detection of HPV DNA.Historically, VIA and Pap smears have formed the backbone of screening efforts within Indonesia’s public health landscape. However, national data from Indonesia’s 2021 Health Profile highlights a major shortcoming: only 1.77 percent of eligible women have participated in screening programs. This is a far cry from the government’s target of at least 70 percent coverage among women aged 30 to 50 years—a goal set in line with the World Health Organization’s (WHO) call for the elimination of cervical cancer as a public health threat by 2030.
The reasons for low coverage rates are multifaceted. Chief among them are social and cultural discomforts, logistical hurdles, and the invasive nature of traditional sampling techniques. Pap smears and VIA, for instance, require direct access to the cervix, which many women—citing embarrassment, fear, or a lack of privacy—are hesitant to undergo. This trend is not unique to Indonesia; cross-national studies find similar reluctance in many societies where social taboos and medical system distrust are prevalent.
Introducing HPV DNA Testing: A Paradigm Shift
The emergence of HPV DNA testing represents a significant leap forward in early cervical cancer detection. Unlike VIA and Pap smears, which either rely on visual cues or cytological changes that may appear late in the disease process, HPV DNA tests can detect the presence of DNA from high-risk HPV types long before any precancerous lesions emerge. This molecular level of detection enables intervention at the earliest possible stage.Crucially, recent advancements allow for HPV DNA testing on non-invasive samples—including urine. For many women, this is a game-changer, promising privacy, comfort, and a reduced psychological barrier. Urine-based screening is particularly appealing in settings where cultural sensitivities or a lack of trained gynecological staff limit the reach and uptake of traditional screenings.
The Indonesian Ministry of Health, recognizing the limitations of existing strategies, has officially pivoted towards embracing HPV DNA testing as the primary mode of community cervical cancer screening. “In previous years, we only used the IVA (visual inspection with acetic acid) test, which mostly detects advanced cancer,” explained Maxi Rein Rondonuwu, Director General of Disease Prevention and Control. “With HPV DNA, we’re catching cancer earlier—before precancerous changes even occur.”
This transition aligns with WHO guidance, which since 2021 has prioritized HPV DNA testing as the key screening method, especially in countries dealing with resource constraints and high cervical cancer burdens.
CerviScan: Pioneering Local Innovation for National Health
Amidst the push for accessible, high-sensitivity screening tools, local pharmaceutical giant PT Bio Farma (Persero) has emerged at the forefront of diagnostic innovation. In collaboration with PT Phapros, Tbk (its subsidiary), startup Nusantics, and academic institutions including the Faculty of Medicine at the University of Indonesia, Bio Farma has developed and commercialized the CerviScan diagnostic kit.CerviScan is a domestically-produced tool that detects HPV DNA from both cervical smears and urine samples. This dual sampling capability is integral not only for increasing screening comfort but also for fostering widespread adoption. Rizka Noviandari, Product Manager at PT Bio Farma, notes, “One key obstacle to wider screening is women’s discomfort with traditional methods. With urine-based alternatives, we hope to boost participation.”
Clinical Trial and Sensitivity
CerviScan underwent extensive clinical trials, involving 900 Indonesian women—a sample size robust enough to provide meaningful data for regulatory and public health purposes. When it comes to sensitivity:- Using urine samples, CerviScan achieved an 80.30 percent sensitivity.
- Using cervical swab samples, the sensitivity soared to 96.43 percent.
Dr. Rizka is candid about the trade-off: “While urine sample performance is modestly lower than cervical smears, the comfort and ease of sample collection are expected to dramatically improve coverage.”
Regulatory Status and Accessibility
CerviScan currently holds a Ministry of Health distribution permit (RI Ministry of Health code AKD 20306220137) and boasts a domestic component level (TKDN) of 40.69 percent, supporting both local production and affordability. The kit has been made widely available through the Kimia Farma laboratory network, with a typical test price of around 400,000 Indonesian Rupiah (IDR), or roughly 27 US dollars at prevailing exchange rates. Turnaround for results is rapid—usually within a single day.The test can detect at least 14 high-risk HPV types, including the predominant oncogenic strains 16, 18, and 52, and is compatible with most polymerase chain reaction (PCR) platforms. This compatibility is vital for scalability and integration within existing laboratory infrastructure, ensuring that widespread adoption is logistically feasible.
Importantly, the validity of a negative CerviScan result holds for up to five years, given the slow progression of HPV infection to cancer. Women are thus advised to repeat screening at five-year intervals, a frequency consistent with major international recommendations. In cases where the test is positive, a follow-up with VIA or Pap smear is recommended to assess the presence and severity of precancerous lesions.
National and International Context: Comparative Effectiveness
The introduction of urine-based HPV DNA testing is not unique to Indonesia but is part of a growing global movement. Several studies, including those from high-income settings such as the Netherlands, the UK, and China, have tested the accuracy and acceptability of urine-based HPV screening. Most have found that while urine-based tests are somewhat less sensitive than cervical smears, they offer strong enough performance to justify their use, particularly as a means to capture women who would otherwise forgo screening entirely.For instance, a 2022 systematic review published in The Lancet Global Health found that first-void urine HPV testing had a pooled sensitivity for CIN2+ (cervical intraepithelial neoplasia grade 2 or worse—a significant precancerous lesion) of over 84 percent, with specificity comparable to clinician-collected samples.
These findings are echoed in the Indonesian clinical trial, adding confidence to CerviScan’s broader application domestically. The key remains public awareness: without high participation rates, even the best diagnostic technology cannot move the needle on national incidence and mortality rates.
Strengths of the CerviScan Approach
- Enhanced Accessibility: Allowing self-collected urine as a sample lowers barriers to screening, making it more feasible in settings lacking specialized clinics or providers.
- Domestic Manufacturing: With nearly half of its content originating locally, CerviScan supports the Indonesian economy, reduces reliance on imported products, and can, in theory, respond more nimbly to local demand.
- Rapid Turnaround and Comprehensive Detection: The PCR-based platform delivers results within a day and covers the major high-risk HPV genotypes.
- Regulatory Approval and Integration: Ministry of Health registration and availability in the Kimia Farma nationwide network means CerviScan is already embedded within the public health infrastructure.
- Public Education and Price Point: At around IDR 400,000, CerviScan is more affordable than many international molecular tests, although government-subsidized options may be needed for mass uptake.
Potential Risks and Limitations
Despite substantial promise, several risk factors and caveats must be acknowledged:- Sensitivity Gap: The lower sensitivity for urine samples compared to cervical swabs or clinician-collected samples could lead to false negatives—women who are HPV-positive but not detected via urine. While better than no screening, this limitation needs ongoing communication and potentially risk-adjusted algorithms.
- Need for Follow-Up: Women testing positive will still require clinical follow-up using VIA or Pap smears and possibly biopsies, which could reintroduce some of the original barriers (discomfort, embarrassment) that the urine test sought to alleviate.
- Equity and Awareness: Even with technological innovation, disparities in access by region, education, and income may persist unless accompanied by sustained public awareness campaigns and healthcare worker training.
- Validity and Rescreening: The five-year rescreening rule is predicated on a negative result and the natural history of HPV infection. Any shifts in risk factors—such as immunosuppression or new partners—may necessitate more frequent testing for some women.
- Laboratory Capacity: Expanding molecular testing to rural areas with limited lab infrastructure may pose logistical hurdles. PCR platforms require stable electricity, careful sample handling, and skilled personnel—issues that must be addressed in implementation.
The Role of Domestic Innovation in Public Health
Indonesia’s approach—developing, manufacturing, and validating a homegrown diagnostic kit for a pressing national problem—is noteworthy and instructive. By investing in local capacity, the country is potentially creating a model for other low and middle-income nations struggling with similar cancer burdens. Moreover, with ongoing adaptation and optimization, domestic tools like CerviScan can evolve based on real-world experience, improving both accuracy and user satisfaction.“The real test now is public awareness and will—no technology can save lives unless people use it,” Rizka Noviandari observes. It is a challenge echoed by health officials everywhere: the leap from laboratory innovation to everyday preventative care demands coordinated action across government, healthcare providers, and civil society.
Next Steps: Scaling Up and Sustained Impact
For Indonesia to achieve its stated cervical cancer elimination targets by 2030, several critical moves must follow:- National Awareness Campaigns: Sustained, culturally-sensitive education efforts must address misconceptions, reduce stigma, and encourage participation across all segments of society.
- Integration with Immunization: Vaccination and screening should be offered in tandem, leveraging touchpoints like schools, maternal health clinics, and workplace health programs.
- Subsidized or Free Testing: For true equity, especially in disadvantaged regions, free or heavily subsidized CerviScan tests (or other validated kits) should be made available.
- Health Workforce Training: Nurses, midwives, and community health workers must be trained in the use of self-sampling kits, sample handling, and patient counseling—not only in large cities but in remote provinces.
- Monitoring and Evaluation: Ongoing research into test performance, outcomes, and cost-effectiveness is essential, with regular public reporting and international benchmarking.
Conclusion: A New Era in Preventative Care?
The rise of molecular diagnostics, epitomized by the CerviScan urine-based HPV DNA test, presents a powerful weapon in the fight against cervical cancer in Indonesia and similar settings. High-profile government support, local innovation, and broad clinical validation suggest that this technology may transform how women access and experience screening.Yet the promise will only be realized if technological advances are matched by investment in public education, affordability, and strong follow-up systems. The early detection of HPV-induced cervical cancer, now possible in the privacy of one’s home or local clinic, could become the new norm—one that not only saves lives but dismantles longstanding barriers to women’s health.
In the battle against cervical cancer, innovation like CerviScan is not merely a scientific breakthrough; it is a potential catalyst for social change, offering millions of women hope for a future free from one of the world’s most preventable cancers. As Indonesia’s experience demonstrates, the path to elimination lies not just in technology, but in the collective commitment to bring that technology to all who need it, without exception.
Source: Kompas.id Detecting Cervical Cancer through Urine
