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Proposed Implementation

According to our theoretical model and simulation studies, we expect that on fully implementing our diagnostic kit with the biomarkers X,Y, and Z we can correctly differentiate a healthy patient from one who has OSCC with an accuracy of

Target Group - Who?

We intend it for use by habitual cigarette and/or tobacco consumers, as well as users facing occupational hazards. However, any user might benefit from the use of this kit.

Further, we also intend this kit for usage locally (within a country) as biomarker levels might be affected by epigenetic and environmental factors.

Target Area - Where?

Our kit can be best utilized at hospitals, medical camps, and dispensaries. Since we do not claim to diagnose cancer with it, we want users to be helped on how to interpret the results. Thus, we do not plan to make this available to retail customers, but only to organizations and NGOs who can demonstrate access to medical professions.

Procedure - How?

While we haven’t been able to create a standarding operating protocol for our kit, we have researched and discussed in depth on these criteria. These are briefly discussed as:

Quantity of saliva and reproducibility of test results
- Since we had to rely on the concentration of MMP9 in saliva from literature, we saw a consistent trend in the relative concentration of MMP9 from different parts of the mouth. We chose to collect saliva from the floor of the mouth (FOM). This was also consistent with our proposed saliva collection device targeting the FOM, for which we won the Frederick Cottrell Impact Grant.
- Volume of saliva: Our results from fluorescent proteins at 300 uL yielded accurate results.
- Frequency of test
  - We have yet to standardize the tests. But after consulting doctors at PGI, we realize that this test will have to be repeated multiple times before a conclusive result can be drawn.
  - To ensure multiple tests can be performed, a larger collection of saliva will be drawn at the time of collection.
Results
- To deliver the results, we have built an app that analyses the spectra and reports the concentration of the biomarkers, then feeds these into a ML model to calculate the percentage risk a user has of developing OSCC. More on this can be found on our software page. We have also built a user manual for the app, which can be found here.

Product design

Our product was designed and built using our in-house 3D printer. The details of the kit and renders are available on the hardware page.

The ray tracing simulation helped us calibrate distances and get an idea of how to develop the optics of it. The entire procedure can be found here.

MARKET ANALYSIS

Addressable market

The total addressable market is expected to be USD 767.90 Million USD by 2024, with a compound annual rate growth (CAGR) of 6.94% for 2018-24

What this means is, for 2018-24, if we average out all the growth in the oral cancer diagnosis market, we will observe a growth of 6.94% annually.

Competitor Analysis - Key Competitors

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Existing detection systems require adequate infrastructure and data interpretation by experts. These kits are thus unsuccessful at places with scarce medical resources. Notably, issues such as limited awareness and financial constraints discourage invasive biopsies. By catching the disease early, we want to motivate people to seek timely professional help by recognising anomalies.

In terms of numbers, we aim to make our kit the most affordable way to check cancer susceptibility and undercut equipment cost to less than a 10th of the existing standards. We also aim to bring down the operational cost by more than 10 times of the current value.

On top of this, we are making the only user-friendly and self administrable test for oral cancer susceptibility.

Target audience

USP- A self-administered, user-friendly, reusable kit that would report the user’s susceptibility to oral cancer.

We are focusing on launching the kit through two models-

B2B Model -

Customer: Hospitals, dentists, pharmacists and more. This would be possible during and beyond the clinical trial stage.

Paid Users: Tabacco consumers, the general public.

It makes it a lot easier for hospitals to screen patients for oral cancer, thereby increasing the availability and load of susceptible cancer patients that a healthcare institute can handle while also making cancer point of care diagnosis more accessible to the consumers.

B2C Model –

After sufficient trials and making the kit self-administrable, we will market the kit to tobacco consumers, health enthusiasts, and the general public. Making oral cancer point of care diagnosis affordable and accessible for everyone.

Addressable market (paying customers) - Health conscious individuals, healthcare institutions, and tobacco consumers.

The end goal of this kit would be to make OSCC screening free or very nominal in cost. Our proposed plan is to mass-produce such kits after due successful clinical trials and approvals. This would bring down the cost further by up to 25 times, making it feasible for the government to buy these in bulk and provide them at a subsidised rate or at government-funded health centres and pharmacies throughout the country and later the world.

Steps to Commercialisation and Timeline

> Establish Proof of concept and apply for a provisional patent - 1 year

> Construct hardware and software prototype - Ready

> Establish Supply Chain - concept and arrangement ready.

> Conduct pre-clinical trials - 1.5 Years

> Conduct clinical trials - 5 Years

> Get approvals for listing - 1 Year

> Market and Scale

All of this amounts to over 8 years before we can freely scale the product.

Cost Analysis

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Predicted growth and market share for OSCC

With the 700+ Million dollar market for Oral cancer diagnosis, OSCCit can position itself as the chief and proprietory tool for the most accessible OSCC diagnosis.

A target share of 1% offsets the high initial investments and long time spent during trials. That is, a revenue of over 7 Million USDs in the initial (pre-approval) stages. This can be achieved through targeted marketing and, strategic placement and partnerships with clinical organisations, IP sharing, obtaining letters of intent and government contracts.

Given that our tool does not require clearance of any special permits to be used and tested (since our sample is saliva), it may not achieve approval to be used as a diagnostic standard soon, but it can still fuel research and serve as an intervention to identify susceptible patients.

Once commercialisation is freely possible, and the kit can be sold and mass-produced, we expect to rapidly capture the majority market share and scale at a drastic level, owing to being the most affordable and accessible means to diagnose OSCC.

PEST, SWOT Analysis, Bussiness Canvas, STP, Product renders and Manual subject to nomination.

FUTURE PLANS

Expanding the prediction model
- First of all we want to refine our machine learning model to include more input parameters, specifically from a local cohort. This will help us better predict the outcomes of elevated protease levels in saliva. For this, we have signed a MoU with <insert name of NGO> to help us with Indian patient data.
- Once a more robust model has been built, we can refine the biomarker thresholds we set out initially to be more representative of its target users.
Get clearance for testing with saliva samples.
- We have discussed this with our Institute Ethics Committee (https://www.iisermohali.ac.in/institute-ethics-committee/committees/institute-ethics-committee) and have started drafting an application for testing human saliva samples in our institute lab.
- Additionally, we would require the saliva samples from patients at PGI, Chandigarh and have applied for an ethics clearance from their Institutional Ethics Committee (https://pgimer.edu.in/PGIMER_PORTAL/PGIMERPORTAL/GlobalPages/JSP/Page_Data.jsp?dep_id=81)