Cervical cancer is the 4th most common variety of cancer in women worldwide, leading to approximately 266,000 deaths annually [1]. In less developed regions, cervical cancer is the second most common cancer after breast cancer [1]. High-risk human papillomavirus (HPV) strains (such as 16 and 18) are the major causes of cervical cancer but can be treated if detected early enough [2]. 

The current standard screening methods for this cancer include the combination or individual usage of cytology (e.g., Pap smear) and HPV DNA testing. HPV DNA testing offers a higher sensitivity and requires minimal laboratory infrastructure, ideal for developing countries [2]. Many countries, such as Canada and the US, are adopting HPV DNA-based testing as the primary screening method. However, it may lead to over-treatment and excessive diagnosis of non-dysplastic cervical lesions as most HPV infections are not clinically significant, especially in women under 30 [2, 3]. As such, there is a need to implement a low-resource, user-friendly platform that can identify relevant cervical cancer biomarkers alongside DNA-based HPV testing to limit false positives. It was shown that the quantification of p16INK4a, a protein marker of HPV infection and its oncogenic activities, by ELISA in fresh cervical samples was feasible and could be used in combination with current screening methods [4]. However, standard protein detection techniques (e.g., ELISA, LFA) are not sensitive and accurate enough to detect these biomarkers in cervical samples given their low concentrations. 

To address this problem, we propose to create an ultra-sensitive protein detection technique applying microfluidics for the p16INK4a biomarker for cervical cancer. A POC device with increased sensitivity and accuracy can be used as an adjunct to DNA-based HPV testing to improve cervical cancer screening, mainly in low-resource settings. 

Cervic-o is no longer continuing as a BioDesign project.

[1] J. Ferlay et al., "Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012," (in eng), Int J Cancer, vol. 136, no. 5, pp. E359-86, Mar 1 2015, doi: 10.1002/ijc.29210. 

[2] S. L. Bedell, L. S. Goldstein, A. R. Goldstein, and A. T. Goldstein, "Cervical Cancer Screening: Past, Present, and Future," Sexual Medicine Reviews, vol. 8, no. 1, pp. 28-37, 2020/01/01/ 2020, doi: https://doi.org/10.1016/j.sxmr.2019.09.005. 

[3] G. Koliopoulos et al., "Cytology versus HPV testing for cervical cancer screening in the general population," (in eng), Cochrane Database Syst Rev, vol. 8, no. 8, p. Cd008587, Aug 10 2017, doi: 10.1002/14651858.CD008587.pub2. 

[4] S. O. A. Leung et al., "Triaging abnormal cervical cancer screening tests using p16INK4a detection by ELISA on fresh cervical samples," American Journal of Reproductive Immunology, vol. 86, no. 1, p. e13394, 2021, doi: https://doi.org/10.1111/aji.13394.