Cervical cancer is a leading global public health challenge, being the second most common cancer in India and the fourth most common cancer among women worldwide. Every year, more than 1,00,000 women are diagnosed with cervical cancer, and around 70,000 women die of cervical cancer in India. The global incidence is also daunting, with 6,60,000 new cases and nearly 3,50,000 deaths annually (data for 2021-22).
Cervical cancer is preventable, but the incidence of the disease is higher than it should be, and there are significant disparities in the rates of timely screening among women of different socio-demographic groups. The percentage of women who are overdue for cervical cancer screening has been growing. The rates of timely cervical cancer screening fell overall between 2005-2024. While traditional screening methods like Papanicolaou (Pap) smears are effective in developed nations, in Low-and-Middle-Income Countries (LMICs) with minimal healthcare infrastructure, the current screening methods fail to make an impact. The result is that over 85% of new cervical cancer cases originate in developing countries.
According to the WHO, 95% of cervical cancer cases are caused by persistent infection of the cervix by HPV (Human papillomavirus). While the body’s immune system clears out most infections, sometimes, persistent infection with HPV can cause changes in the cervical cavity that can progress to cancer. This progression occurs in stages: infection, pre-cancerous stage without symptoms, and early and late cancer stages when symptoms appear and become more prominent. Preventive/curative measures can be implemented if the risk is screened in infection/pre-cancerous stages. Recognising this, the WHO recommends HPV DNA testing as a primary screening method starting at age 30, with follow-up screenings every 3-7 years
However, only 2% of women in India have been screened for
Innovation Gap in Early Screening of Cervical Cancer
In India, there are limited screening solutions that can detect cervical cancer at early stages. Current screening methods have some limitations –
Limited last-mile access in underserved geographies/communities:
Screening facilities are often far from home for those in rural and underserved communities. Long travel times, potential income loss, and lack of awareness about the importance of follow-ups lead many patients to abandon the process after initial tests. There is no standardised method for patient tracking after drop-out, ultimately leading to missed cases which can develop into cancer.
While the gold standard test for HPV detection has high sensitivity and specificity of detection, it is dependent on lab infrastructure and skilled professionals, with results often taking over 24 hours. The availability of this test is mostly limited to urban areas (Tier 1 or 2 cities), making it inaccessible to the larger population.
Low accuracy:
Existing screening tests such as pap smear or visual examination have low accuracy. While false positive results can create fear in the community, especially in the case of cancer, false negatives can lead to missed cases.
Insufficient early risk detection:
Current testing methods are not designed to identify infection stages with precision. Most solutions can only test for symptoms, which means the disease has already set in. There is a dearth of solutions that can precisely identify risks even before symptoms appear. This is a missed opportunity for proactive treatment and prevention of cervical cancer.
There is a pressing need for innovative solutions that improve access, ensure accuracy, and enable early screening.
Company’s Innovation and Technology
bioLOCKEY is developing selfCERVIX that offers a rapid, cost-effective, and accessible solution, which can detect multiple high-risk HPV strains that constitute >97% of high-risk subtypes prevalent in India, with a single, minimally invasive test at point-of-care.
Its rapid turnaround time of under 10 minutes and seamless ‘sample-in-answer-out’ workflow overcome the limitations of current methods. Additionally, its at-home self-sampling and bedside self-testing capabilities can eliminate the need for multiple clinic visits, which is particularly beneficial in remote areas.
The test will be in the form of a lateral flow assay (LFA). However, unlike conventional antibody-based assays, this LFA is based on single-domain nanobodies. The integration of nanobody-on-paper assay technology enhances accuracy and enables remote monitoring. In line with the WHO’s recommendations, this solution can identify the risk of cervical cancer by indicating recurring/persistent infection with high-risk HPV strains.
With this easy-to-use point-of-care solution, it will be feasible to make screening accessible even in difficult geographies where lab infrastructure and skilled professionals are not available. Regular screening of patients can result in early risk identification followed by necessary precautions or treatment.
Market Potential and Business Viability and Scalability
The healthcare sector is becoming more consumer or community-focused, and thus, there is an increasing need for solutions that are available, affordable, and convenient to use, closer to patient locations. The point-of-care nature of bioLOCKEY’s solution makes it relevant for varied settings, including both public and private markets. Vaginal self-sampling and HPV self-testing represent a pivotal shift in healthcare access, decentralising services and easing the pressure on medical infrastructure and professionals.
The public sector market in India and other countries needs a solution that can do community-level mass screening for HPV infection to reduce the risk of cervical cancer. bioLOCKEY aims to work closely with key public sector partners to deploy the solution to the community. For example, the ongoing NCD screening program in India can benefit from this kind of easy-to-use yet accurate solution when launched in the market. In the private sector, where current tests are limited to hospitals and clinics, bioLOCKEY’s product will enable clinicians to get quick HPV test results, reducing patient wait times and the risk of dropouts.
The global market for cervical cancer screening was valued at $ 2.1bn in 2020 and is expected to reach $ 9.1bn in 2027, with a CAGR of 23.1%. The CAGR in Low and Low-Middle-Income countries is even higher, with potential for growth at 37.5% and 31.9%, respectively. This market surge is fueled by rising cancer rates, targeted government initiatives, and new research breakthroughs. In India, the total addressable market (TAM) for cervical cancer screening, including the age group of 30–60-year-old women, is about 207 million. The total serviceable market (SAM), which is women between 19 and 65 years, is 45 million.
Additionally, bioLOCKEY’s product is built on a platform technology, which can be expanded to other use cases in the future, such as other cancer types (HPV- mediated head and neck cancers) or rapid lateral flow-based diagnostic tests built on the same scientific principles.
Potential Impact Creation
bioLOCKEY’s HPV test can reach remote geographies. As per early projections, the solution has the potential to do more than 3,00,000 tests in 5 years Through regular testing, the predictability of developing cervical cancer can be improved, and the risk of developing invasive/non-curable cancer can be reduced.
The selfCERVIX diagnostic test has the potential to revolutionise gynaecological oncology by addressing the critical need for accurate and convenient cervical cancer screening globally. Despite advancements, the current state of practice falls short of addressing the diverse needs of populations across different income levels and geographic regions.
By enabling early detection of conditions like cervical cancer, this approach not only bolsters convenience but also fosters a proactive healthcare ethos, ultimately contributing to a more equitable distribution of resources and a healthier female population.
The Founders
The two founders of bioLOCKEY, Dr Anchal Chandra and Dr Minhaj Sirajuddin, come with extensive deep science research experience and are passionate about bringing sustainable change in healthcare diagnosis through their innovation.
Dr Anchal Chandra, the CEO and Founder of bioLOCKEY, brings over 15 years of R&D experience in small molecule therapeutics and drug discovery. Her impressive career includes roles as a senior scientist at the National Centre for Biological Sciences (NCBS), India, and extensive scientific work at MRC, Cambridge University, UK. She did her postdoctoral research at Stanford School of Medicine, USA, and her doctoral research at the Max-Planck Institute, Germany. She specialises in bioengineering, molecular genetics, screening, and validation for biomolecules.
Dr. Minhaj Sirajuddin, Director and Co-founder, is a distinguished professor at InStem, India and has over 20 years of research experience in Structural Biochemistry and Crystallography from his tenure at UCSF, CA, USA, and the Max-Planck Institute, Germany. His expertise lies in protein engineering, nanobody-based biologics discovery, and the development of the nanobody discovery platform for product development.
Together, they are well-positioned to develop bioLOCKEY’s product with desired scientific and clinical features.
The Way Forward
BioLOCKEY has proof of concept for selfCERVIX and has made significant progress in discovering core components for the screening test. The company is aiming for a commercial launch of selfCERVIX by the end of 2025 and is working towards this goal by finetuning in-house product development and validation through clinical trials.
By investing at the proof-of-concept stage, Social Alpha can de-risk the early lab-to-market journey of this deep science company with immense impact potential. Social Alpha will work collaboratively with the bioLOCKEY team and provide customised support through product development planning and feedback, vendor connects for key activities, clinical partnerships, and operational planning, among others.
– Written by Pragyan Sagarika Pani, Social Alpha