About This Project
Cervical cancer is the 4th most common cancer in women, globally. High-risk HPV infections cause over 99% of these cancers. Infections can be detected during the (pap) smear test, with a lab-based assay. However, 1 in 3 women and people with a cervix don't attend screening when invited. In many countries testing for hr-HPV doesn't even exist. We are developing an at-home test for hr-HPV that is easy, fast, affordable and reliable.
Ask the Scientists
Join The DiscussionWhat is the context of this research?
Cervical cancer is the 4th most common cancer in women globally. It accounts for over 300,000 deaths every year. HPV causes over 99% of all cervical cancers. Infections can be detected by HPV testing during cervical screening, thereby preventing cervical neoplasia from ever developing.
Despite HPV testing being available for many in the developed world, 1 in 3 women when invited do not attend cervical screening due to the nature of the smear test.
Our new diagnostic technology is unlike anything already in existence. It will enable users to detect infections in samples in under 30 minutes, and results will be generated at home. We will provide a user-friendly, convenient alternative for assessing HPV status.
What is the significance of this project?
The current cervical screening test, or (pap) smear, is viewed by many as an incredibly invasive, embarrassing procedure that takes those attending away from their paid work and family commitments. Accompanied by an anxious 2-4-week wait for results.
For those living in countries without a screening programme, getting screened at all can be an impossible task. In Nepal for example, women can walk for days to attend a screening camp. Then the test performed has to be one that can provide an instant result, cheaply.
We propose to develop an 'at home' test that can detect hr-HPV infections with the same sensitivity and specificity as the lab-based tests currently used.
Only testing positive (<9% of cases) would require medical follow up.
What are the goals of the project?
Proof of concept testing will be achieved by assessing the specificity and sensitivity of the technology using synthetic virus, extracted virus and patients samples. All experiments will be performed in triplicate to ensure statistical significance can be determined.
We will test all high-risk types of HPV rather than just types 16 and 18 and incorporate each into our final assay design.
Results will be validated against the gold-standard HPV primary screening assays on the market and approved for use by either the FDA or NHS.
Finally we will compare our assay using patient samples and known results from the NHS Cervical Screening Programme. This will ensure our assay is as efficient as those currently in use.
Budget
We have designed our assay and analysed all high-risk HPV types, and designed the relevant assay components required. We are now ready to order these and test them, we just need your help!
In order to validate our assay and make sure it can work in all environments, we need to test many components in parallel. These tests will be performed under varying conditions, temperatures, durations, concentration of virus and assay components. We will use synthetic HPV sequences, also checking other viruses and human DNA/RNA. We will then validate the assay using purified HPV genomes and patient samples.
This funding will allow us to set up our testing facility and start performing our experiments.
We have a list of supplies needed in order to validate our technology. These include: specific components including DNA sequences, plastic lab-ware, gloves, pipettes, enzymes, dyes and buffers.
Endorsed by
Project Timeline
We expect to show proof-of-concept for our new diagnostic technology within 6 months, and then go on to validate the technology with patient samples.
Jul 03, 2023
Project Start Date
Jul 03, 2023
Project Launched
Sep 04, 2023
Proof of concept testing using synthetic HPV sequences
Nov 06, 2023
Proof of concept testing using HPV genomes
Feb 05, 2024
Sensitivity and Specificity testing using extracted HPV from cell lines
Meet the Team
Angela Pine
I am incredibly passionate about Women’s Health issues. I have previously worked as a Trustee and COO of UK Cervical Cancer, a charity raising awareness, and educating on causes of cervical cancer as well as the importance of screening.
I believe strongly in brining about health equality by ensuring access for ALL to better diagnostics, especially in the women's health space.
This is why I founded 10zyme, a FemTech start up committed to developing more accessible diagnostics across the Women’s Health space.
I am an accomplished researcher with over 9 years’ experience working in cancer research as a molecular engineer developing novel diagnostic and therapeutic technologies.
I am a Health and Care Professions Council (HCPC) registered a Biomedical Scientist and have worked for many years in NHS affiliated diagnostics laboratories.
Recently I was at the forefront of scientific innovation in diagnostics; designing, developing and validating a novel diagnostic for SARS-CoV-2 during the global pandemic.
I also teach and conduct research outside of 10zyme at a University, developing functional nucleic acids as potential therapeutics and biosensors for disease.
Lab Notes
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Project Backers
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