Our Team's Path To Implementation
SEED has the potential to be a versatile technology platform with a number of different applications (see Applications page), but because the idea was inspired by COVID-19 testing, we focused on designing an implementation strategy for SEED as a viral diagnostic. In terms of sample collection, the goal is for SEED to function as a non-invasive test, allowing the user to simply expose a saliva or cough sample to the cells in order to get a read-out. This implementation page will focus on that application, moving forward. To implement our invention into a product
1. Validation and Optimization in Lab
Before our invention can be commercialized as a product for public consumer usage, we must answer several questions in a lab based setting. Currently, we are in the Proof-of-Concept stage of research, establishing answers to base questions that will inform what is and isn’t possible for our diagnostic. We are developing ways to test RNA uptake and detection in B. subtilis, in parallel with optimizing DNA uptake for ideal use case conditions. Once our research has established a solid Proof-of-Concept invention, we can move on to clinical implementation. We cannot have a feasible product for implementation until we can prove accuracy and feasibility.
Once we do have the capability to show a proof of concept, we will be able to leverage connections we have already made with our entrepreneurship ventures so far to move into the clinical phase.
2. Clinical Testing and FDA Approval
Before our invention can be commercialized as a product for public consumer usage, we must do clinical trials and testing, as well as get FDA approval. This is a crucial step that is the bridge between the initial proof-of-concept and the actually implementation to bring the test to market. Once proof-of-Concept has been established, we can begin clinical trials.
This step would include testing with patient samples, and setting up the test in a non-laboratory setting. We would further test mutation rates, viability outside of the lab, sensitivity and specificity, and scalability in a clinical setting. Once clinical trials are complete, we would move into FDA and other approval stages.
Luckily, have begun establishing partnerships and collaborations to help prepare us for the approval processes, and inform our research design now to optimize for real world implementation. One key partnership that we have developed in order to help us start preparing for this process has been Stanford Medicine Catalyst. This program will be instrumental for us as we approach these next steps, as the program offers access to a team of experts who are helping us tailor our experimental design so that we have all the information we need in order to successfully go through the approval process. They have also offered to connect us with people at the medical school to set up clinical trials, and are eagerly waiting for us to show a proof-of-concept so that we can get started.
3. Production and Distribution
B. subtilis has a doubling time of two hours under optimal conditions. Additionally, it can be sporulated and shipped around the world in the mail. Distribution and scaling are easy for this product. We would like to implement a system that allows consumers to specify their desired target sequence and readout, and we would ship them a kit containing their unique cells and all the required reagents to culture and use them - in a kit we like to call "Bac Pac" - which you can read more about on the Entrepreneurship page.
What Does SEED Look Like In The Real World?
In the near future, SEED is a simple, cheap, effective diagnostic kit. It can be shipped out to healthcare settings, and contains sporulated cells, media, plates, and all other materials necessary to successfully use the test. In the future, SEED will become a customizable diagnostic system that can be shipped around the world to help enable easy, at-home assays for any nucleic acid sequence of interest.
After we have the first iteration of SEED compatible for COVID-19, we’ll develop BacPac, the standard-environment kit that can be deployed in clinical or at-home settings in a decentralized way. In the clinic, the infrastructure already exists to easily culture the bacteria and transport them between clinics for point-of-care use. At home, the consumer will be able to buy the test and culture the test themselves using common household materials. We’re also thinking about ways to spray SEED cells onto used tissue paper, or alternatively embedding the cells into tissues for non-invasive detection.
We will partner with Culture Biosciences to power the manufacturing of SEED using their cloud-lab bioreactor service. We’ll then partner with Vera, from the Stanford Med School, to plug into their scalable distribution pipeline. We’re hoping that by April 2021, we’ll be able to provide tests to the San Francisco Bay Area and get feedback on our product. After optimizing BacPac, we hope to expand to the rest of the US by Summer 2021.
Our long term goal is to make SEED an open-source technology with the ability to sporulate the bacteria and ship them anywhere in the world. This technology will be accompanied by a website designed for clear and up-to-date communication about SEED, and how it can interface with public health intiatives.
Behind the scenes, we’ll have refined the interchangeability of target sequences and developed algorithms that predict the optimal sequence in any genome for our system to target.
We’ll have expanded our initial team to hire experts in microfluidic engineering. We’ll incorporate our SEED cells into flexible microfluidic-RF devices, so that we can embed our cells in any environment and provide continuous monitoring of disease. We expect this to be ready before Autumn 2021.
One of our long term goals is to turn SEED into a biological wearable that could live within our bodies to constantly monitor infectious disease or genetic mutations. This will take an enormous amount of trust from the public, which is why we’d have to run an educational marketing campaign first, and then allow pre-orders to see if there is enough demand. However, the use of our microbiome for computing is inevitable...