Introduction
Our Journey from an Idea
Entrepreneurship isn't just about profit, it's also about making a positive impact in society.
Since the time we started working on our project, our aim was to alleviate the major stigma related to mental health prevalent in the current society.
Seeing the immense potential of blood biomarkers in detecting several diseases in recent years, we are very excited to determine their correlation with mental disorders as well. This will be an extremely unique approach to diagnosing mental health diseases since it will connect mental illness to tangible physiological changes in a person's body just like any other physical disease.
Till now it was just an idea, but this is where we plan to take it ahead as a startup. We embarked on our entrepreneurial journey by attending the iGEM Startup Summer School which was a two-day boot camp giving us a glimpse into how startups work. Thereafter we also presented our project at the All India iGEM Meet and participated in the startup elevator pitch competition. Here we got a lot of valuable input and also the opportunity to interact with experienced innovators and entrepreneurs. To understand the workings of startup industries especially in the biotech field, we have currently enrolled and are undergoing a 9 week Bio-Entrepreneurship Program wherein we get to learn more about ideation, building prototypes, networking, market analysis, revenue generation etc. By the end of the program we'll be given a chance to pitch our project in front of renowned VCs and angel investors. Through conscious efforts like these we are confident to take our project further into the real world, potentially revolutionizing the mental health care industry.
Market Analysis
Market Gap - Need for a Diagnostic Aid
Despite the prevalence of mental illness, progress in developing accurate diagnostics has been lagging. Several laboratory tests are available to diagnose MDD, but they are either extremely expensive or not viable due to the slow processing time of its result. Reviewing the current situation, the most commonly used methods are self-report questionnaires and clinical interviews, which are subjective and variable. There is need for a diagnostic tool that can generate objective results for MDD at a reasonable cost and aid clinicians in their diagnosis. This will eliminate subjectivity and falsification in self-reported data, significantly reduce misdiagnosis, and improve efficiency in identifying and treating clinical depression. Using blood biomarkers to diagnose MDD will be a paradigm shifting novel approach.
Our Stakeholders
- Hospitals, Clinicians, Psychiatrists, Neurologists
- Researchers
- Antidepressant Pharmaceuticals
Our tool will help in a more conclusive diagnosis of major depressive disorder in patients of different ages or social groups. It will also help monitor improvement in the patient's condition by regular monitoring of blood biomarkers and tracking the medication efficacy.
Our technology can be used to study the efficacy and build data for different sets of biomarkers and can be extended to other diseases as well.
Pharmaceutical companies could use the kit to test the functionality and efficiency of developing antidepressant drugs.
Existing Market and Demand
With a focus on accessibility, digitalization, and reducing the stigma surrounding mental health disorders the market for mental healthcare has undergone significant changes recently. It is anticipated to grow further as awareness of mental health issues increases with an emphasis on personalized care, early intervention, and holistic well-being.
However, ongoing research, validation, and ethical considerations will play a crucial role in shaping the future of this market.
Major depressive disorder (MDD) currently affects at least 280 million people worldwide[1], and according to the World Health Organization, it is predicted to be the leading cause of disease burden worldwide by 2030[2]. WHO also released a scientific brief which says that following the COVID-19 pandemic, the global prevalence of anxiety and depression has increased by a massive 25%[3].
In our state, Kerala, alone, the prevalence of mental disorders was reported to be 12.43% in 2017. The number of individuals with mental health illnesses in the state increased from 272 per 100,000 to 400 people per 100,000 from 2002 to 2018[4].
With our tool, we expect to reach out to the startling number of patients suffering from mental disorders in Kerala. Even though our product is directed to Clinicians, Researchers, and Pharma companies, a more significant number of people will be directly or indirectly impacted by our product. Hence all our stakeholders, including those suffering from mental health disorders and those at risk, are part of our extended service obtainable market.
Competitor Landscape
Our tool will act as an aid to the currently used methods for diagnosing MDD which includes self-report questionnaires and clinical interviews. Without an objective quantification method there are high chances of misdiagnosis, subjectivity and variation[5].
Alternatively, the existing commercially available approaches for diagnosing MDD are non-specific and unreliable[6], such as the dexamethasone suppression test (DST) that measures the extent to which cortisol secretion by the adrenal glands can be suppressed. It is pretty expensive and can't be a screening tool in itself because of its detection limited to cortisol levels only.
Spinal tapping is another technique but again is highly expensive and not the best preferred method because of its invasive and inaccessible nature[7].
Proposed Product
Overview
As a product, our device OASYS would analyze a sample of human blood and quantify the concentration of different biomarkers related to MDD. The device is based on the principles of FRET, fluorescence resonance energy transfer, and is accurately controlled using the principles of microfluidics.
SWOT Analysis
We used SWOT analysis for our product to capitalize on its strengths, identify and work on weaknesses, maximize opportunities, and reduce any risks, all of which are critical for long-term success.
Technology Readiness Level
Our readiness explained :
- TRL 1: Basic principles observed. Scientific observations made and reported. Conducted necessary research for building this device. Click here for references.
- TRL 2: Technology concept formulated. Envisioned applications are speculative during this step. At this stage, we had enough analytical study to understand its sensitivity and specificity, so we used green LED to determine the same. Click here for more information.
- TRL 3: Experimental proof of concept. Effective research and development initiated. We used lab samples such as PTE in DCM to check the sensors' behaviour, sensitivity, and specificity.
- TRL 4: Technology validated in the lab and through designed investigation.
We used our actual lab samples to validate the hardware, compared the fluoro-log results with the ones we got, and showed similar trends in values. Click here for more information.
This is a significant milestone, demonstrating that the device can detect fluorescence from biological samples with high sensitivity and specificity in a laboratory environment. Still, we are planning to extend it further in the future.
Our further plans :
- TRL 5: Technology validated in the relevant environment. Using real-world samples involves testing the device in a clinical setting or research laboratory.
- TRL 6: System/subsystem model or prototype demonstrated in a relevant environment. It involves developing a prototype of the device ready for use in a clinical setting or research laboratory.
- TRL 7: System prototype demonstration in an operational environment. Evaluating its performance in a real-world environment involves deploying the device in a clinical setting or research laboratory for a limited time.
- TRL 8: Actual system evaluated and tested. It involves conducting a clinical trial or research study to assess the safety and efficacy of the device.
- TRL 9: Actual system completion and qualification in an operational environment. It involves deploying the device in a clinical setting or research laboratory for routine use.
Business Plan
Timeline
The proposed timeline for our project is as follows-:
Product Features & USP
- Multiple Biomarker Analysis The diagnostic device incorporates multiple biomarker analysis, entailing the simultaneous examination of different biomarkers under the same conditions. This multifaceted approach enhances the diagnostic accuracy by providing a better understanding of the physiological indicators, contributing to a more reliable assessment of the patient’s health status.
- Objective Results The device provides objective results, minimizing subjective interpretations. By relying on precise analytical techniques and algorithms, the diagnostic outputs are devoid of human bias, ensuring a standardized and impartial evaluation. Not only does this enhance the credibility of the diagnostic process but also contributes to the consistency and reliability of the results across different users and settings.
- User friendly nature The design of the device is user friendly and intuitive, ensuring that healthcare professionals with basic technical expertise can integrate into their routine workflow without much hassle.
- Fast processing The assays are designed to be completed in the span of a few hours, making it an ideal POCT device. This helps accelerate the diagnostic process as well as helps in timely interventions.
- Unique technology: Can be extended to other diseases! The technology behind OASYS can also be extended to similar kinds of biomarkers for other diseases, especially those with well established blood biomarkers.
Value Creation and Cost Analysis
The existing mental healthcare system can be expensive for an average person if they are not diagnosed correctly. This is because they have to go through multiple consultations & sittings, and take different medicines before they are finally diagnosed and prescribed with correct medications that actually work on their targeted needs.
Hence a diagnosis made with the aid of our tool will actually cut down on time, effort and money for the patient and doctor as well, since it will greatly reduce the chances of misdiagnosis in the first screening itself. Not just that, it will also objectively indicate the physiological aspect that needs to be worked upon, which will be helpful in prescribing medications accordingly.
To do the cost analysis of our product, we divided it into 2 phases-:
- Prototype Development Cost
- Final Product Development Cost
An estimated cost breakdown for our prototype is as follows-:
Hardware Protoptype Cost
| Components | Model Number | Cost (INR) |
|---|---|---|
| Photodarlington transistor x 2 | L14F1 | 410 |
| Arduino UNO R3 | UNO R3 | 589 |
| 16 Bit ADC Convertor | REES52 ADS1115 | 800 |
| LCD Display Module | SPI 128x160 TFT | 362 |
| Blue LED x 2 | C503B-BCS-CV0Z0461 | 67.2 |
| 3D printing | - | 600 |
| Total | 2828.2 |
Microfluidic Chip Prototype Cost
| Components | Cost (INR) |
|---|---|
| 3D printing | 4200 |
| PDMS curing and Vacuuming | 2000 |
| Aptasesnsor | 55 |
| Nanoprobes | 250 |
| Total | 6505 |
An estimated cost breakdown for our final product is as follows-:
Final Hardware Cost
| Components | Model Number | Cost (INR) |
|---|---|---|
| Photodarlington transistor x 5 | L14F1 | 500 |
| PCB controller | - | 300 |
| LCD Display Module | SPI 128×160 TFT | 150 |
| Total | 950 |
Final Microfluidic Chip Cost
| Components | Cost (INR) |
|---|---|
| Chip | 200 |
| Aptasensor | 50 |
| Nanoprobes | 166 |
| Photomask (initial investment) | ~100,000 |
| Photolithography treatment for production of photomask mould | 25,000 |
| Total cost of making one chip (dismissing initial investment) | 416 |
| Total cost of making chip (counting initial investment considering at least a 1000 are sold) | 541 |
The hardware is designed to be a one-time investment, lasting several years based on its conditions of usage. For each blood test, only the chip will have to be replaced which will be the main thing affecting the cost of diagnosis. Also, it is worth mentioning that the overall price of product manufacturing is bound to reduce even further when it is mass-produced on a larger scale.
Future Goals
- Publishing our work We would like to share our results with the broader scientific community. Going through the peer-review process and obtaining expert feedback will help us improve our experiment choice, data interpretation and presentation. To this end, we have meticulously kept our experiments' records with appropriate controls, replicates and statistics to ensure reproducibility. We will also update our protocol with pioneering changes in measurement and quantification to help make tool as inexpensive as possible.
- App tracking We plan on proposing a mental well-being tracking app, which will help patients under medication track the biomarker levels in their blood, remind them to take medication, and keep up with regular appointments with a doctor. The app will also help patients regulate their sleep cycle and help maintain a healthy diet adding up to the individual's overall well-being.
- Improving efficiency and accuracy Further optimisation and standardization have to be performed in order to increase the efficiency and accuracy of the microfluidic chip. A list of proposed experiments can be found in the Implementation page under Optimising OASYS.
- Adding more biomarkers based on research In the future if more reliable blood biomarkers of MDD are established, we can incorporate them into the design of the kit by manipulating the sequences of our quantifiers. Thus it promises to be an ever-evolving technology.
- Education Adopting an innovative approach is imperative to advance beyond the constraints of the current educational system. Our goal is to initiate educational ventures to introduce people to the fascinating field of synthetic biology without any age, gender, or language constraints. We want our diverse Indian culture and history incorporated into our educational efforts. The syncretic exercise of spreading the beauty of science through our traditional art forms— street theater and music is how we hope to reach the broadest possible audience in our immediate vicinity.
Funding Plan
We have already pitched our project to government authorities in Kerala like Kerala Startup Mission (KSUM) and Kerala Development and Innovation Strategic Council (K-DISC). Both of which gave us encouraging inputs and have promised financial support in later stages of product development.
To understand the workings of startup industries especially in the biotech field, we have currently enrolled and are undergoing a 9 week Bio-Entrepreneurship Program wherein we get to learn more about ideation, building prototypes, networking, market analysis, revenue generation etc. By the end of the program we'll be given a chance to pitch our project in front of renowned VCs and angel investors.
References
1. https://www.who.int/news-room/fact-sheets/detail/depression
2. https://apps.who.int/gb/ebwha/pdf_files/EB130/B130_9-en.pdf
3. https://www.who.int/publications/i/item/WHO-2019-nCoV-Sci_Brief-Mental_health-2022.1
4. Joseph, J., Hari Sankar, D. & Nambiar, D. The burden of mentan Kerala: a secondary analysis of reported data from 2002 to 2018. BMC Public Health 21, 2264 (2021). https://doi.org/10.1186/s12889-021-12289-0
5. Pedrelli, P., Blais, M., Alpert, J., Shelton, R., Walker, R., & Fava, M. (2014). Reliability and validity of the Symptoms of Depression Questionnaire (SDQ). CNS Spectrums, 19(6), 535-546. doi:10.1017/S1092852914000406
6. Verma,R.K.,Kaur,S.David,S.R.,(2012).An Instant Diagnosis for Depression by Blood Test,J Clin of Diagn Res. 6(9), 1612-1613. 10.7860/JCDR/2012/4758.2579
7. American Journal of Psychiatry. https://doi.org/10.1176/ajp.144.10.1253