An Innovative Decentralized Approach for Cervical Cancer Prevention: p16 Lateral flow Device Development as Point of Care Test.

Oncogenic HPV infection is the causative factor of cervical cancer. As per natural history, this infection is transient and majority of women clear this infection by period of 18 months. Molecular HPVDNA testing

is a recommended test for cervical cancer screening as it identifies women with HPV infection. The limitation of this test is that it cannot differentiate between progressive or transient infection. This leads to unnecessary referrals to tertiary care centers and dropouts in referral pathways. There are evidences of p16 INK4A as a surrogate marker of progressive HPV infection transforming into precancerous and cancerous cervical lesions. This biomarker can identify women at risk of developing precancerous lesions who need immediate referral for treatment. P16 INK4A is a recognized biomarker for both immunocytochemistry and immunohistochemistry. Although more objective, the major limitation of these testing is that, neither of them are field deployable. The proposed solution is a requirement-focused innovation wherein an established bio-marker p16 INK4Ashall be utilized as a point-of-care test with enhanced sensitivity such that it can be deployed for primary screening in a low-resource setting for providing an effective preventive screening strategy.

This test proposed  is positioned to be an affordable, field-deployable screening kit that shall fill the lacunae of recall for further diagnosis and treatment. This shall also enable an immediate course of treatment for women testing positive for p16 INK4A and thus comply with WHO’s screen and treat policy. This strategy shall help us in nearing the WHO set targets of treating 90% screened positive women. The screening test can reduce the colposcopy burden as well as the burden posed by recalling women back every year for a follow-up in case tested positive on VIA or HPVDNA primary screening test.