InstaSerum

Cancer is the second leading cause of death globally and by 2040, the number of cancer related deaths are expected to rise to 16.4 million per year. There is an urgent need for early cancer detection and the use of serum biomarkers for this purpose has been gaining attention recently. However, utilizing serum biomarkers for cancer detection is a laborious process that involves venipuncture, centrifugation of the blood sample to separate serum, and immunological assays for diagnosis. Our goal is to simplify the process by making serum separation rapid, less painful, and cost-effective. We are building a modified syringe to draw blood and separate serum in the same device, which not only makes the process quicker but will also reduce the disposal of 3.5 million vacutainers per year. This technology will assist with the early detection of different types of cancer with just a single draw of blood.

On the global scale, 16.4 million cancer-related deaths per year are expected by 2040. In Canada, patients experience significant wait times for major cancer diagnostic technologies across provinces, such as 5.4 weeks for CT scan, 11.1 weeks for MRI, and 3.5 weeks for Ultrasound. Currently, with COVID-19 placing an immense pressure on the healthcare system, patients who are predisposed to cancer have reduced access to healthcare, resulting in an urgent need for better diagnostic tools. Through our technology, we aim to assist users with simple, early, and faster detection of cancer. In terms of biomedical waste management, syringes and vacutainers are incinerated and discarded after use. By combining blood draw and serum separation in a single device, we aim to reduce the disposal of 3.5 million vacutainers per year. Thus through our technology, we aim to tackle the gaps in both early-stage cancer diagnostics and environmental sustainability.

InstaSerum is a unique one-step, non-invasive technology that employs the use of a lancet for capillary blood collection, and a real-time membrane filtration technique to separate serum from blood. The blood is collected in small volumes (~70 microlitres) and is passed through a biofilter to separate serum from whole blood. With our device design, both the processes can be performed in just one device, eliminating the need to store or ship blood samples to a lab/clinic for centrifugation. We aim to combine our device with existing immunological kits for cancer detection and provide it to our users. Users can then test for cancer-related serum biomarkers through a simple draw of blood, isolate serum and perform the analysis with the kit provided. If the diagnostic analysis, points to cancer, our users can immediately seek the help of a physician for the next steps.

InstaSerum is ideal for anyone who may be predisposed or susceptible to cancer or who would like a hassle-free approach to early-stage cancer detection. As cancer is a serious illness that can be asymptomatic during its initial stages, it is important to act immediately upon noticing even minor symptoms like a lump, increased fatigue, or dramatic weight loss. 

COVID-19 has put a lot of the diagnostic healthcare services on hold, and this has increased the wait times for accessing early-stage cancer diagnosis. It might be risky to others and to oneself to visit hospitals in a non-emergent situation like routine health check-ups during these times. The commercial diagnostic kits available now lack a serum separation device - the one component that prevents those kits from being user-friendly. 

InstaSerum is thus designed by understanding the existing gaps and keeping in mind the demographics of the user population, the volume of the blood sample that needs to be drawn, and the volume of serum that is required for testing. While traditional screening methods require more time and can be laborious, InstaSerum will enable the user to perform the initial diagnosis from the convenience of their home.

Canadian Cancer Society estimates that nearly one in two Canadians will develop cancer and about one in four will die from cancer during their lifetime. According to recent statistics, 63% of Canadians with cancer survive for at least 5 years after diagnosis, making early detection very crucial. 

With COVID-19 placing a burden on the healthcare system, InstaSerum provides rapid, affordable, and convenient early-stage cancer detection at patients' homes. These three aspects of the device are well aligned with healthcare security and pandemic challenge, as it will relieve stress on healthcare systems and prepare communities to deal with cancer better.

We have extensively reviewed published articles for our design idea, hypothesized our theoretical solution with a 2D design, and are currently working towards our 3D design. 

We have completed our primary market research which shows the need for a simpler medical device to isolate serum in smaller volumes, for it to be used with immunological diagnostic kits to check for tumor biomarkers.

Currently, we have partnered with the University of Alberta’s Innovation, Creativity, and Entrepreneurship (ICE) Incubator program and Health Incubator program to develop the working prototype (modified syringe) by the end of summer 2021 and we aim to test and validate the prototype by the end of 2021.

Innovation is bringing a change to an already existing solution in order to solve problems in a more efficient manner. Studies have shown that many existing at-home, early-stage cancer screening tests require the collection of stools, saliva, and/or blood samples for early-stage cancer diagnosis. These samples are collected at home by the patient and are sent to labs, and/or clinics for further analysis. 

InstaSerum, is an integration of two different technologies, blood collection, and serum separation. The goal of this project is to teach individuals how to diagnose and/or screen for early-stage cancer at home. Once the serum has been separated from blood, the individual can check for cancer biomarkers in the serum by using the at-home cancer diagnostic test assay. This eliminates the need to send blood samples to the lab or clinic for further analysis. The process is also rapid, less painful, as well as cost-effective. 

InstaSerum is a modified double-chambered syringe that utilizes two separate biological processes: a) blood collection - performed using a lancet and b) membrane filtration - serum separation from whole blood using a membrane of the required pore size. The novelty of the device lies in the design which captures the two processes in a simple one-step technology. Typical point-of-care testing (POCT) kits require about 30 microlitres (µl) of serum, which means ~70 microlitres (µl) of blood must be collected to separate serum. 

Based on this concept, the lancet gauge was selected to draw the required volume of blood in the first chamber through a finger prick. The negative pressure created inside the syringe using the plunger draws the collected blood through the membrane filter for the separation of platelets, red and white blood cells. The filtrate collects in the second chamber of the syringe, which can be pipetted out and used for antigen testing. 

Our technology is well supported by published research, where researchers have used membrane filtration techniques to separate serum from blood samples. Taking into consideration the sample collection method and the volume of blood samples to be collected, we have employed the same technique in a modified syringe. We have selected the membrane filter based on the size of the cell and platelet content of blood samples. The filter then separates out the serum by removing RBC, WBC, and platelets from the blood sample. Since we are using a syringe, we have calculated the pressure threshold required to maintain the stability of the membrane and the hematocrit value of the serum. These parameters have the theoretical value of isolating highly pure serum which could then be used to test for antigens. 

 References:

1. Cancer antigens in the serum: Choi, J. W., Moon, B. I., Lee, J. W., Kim, H. J., Jin, Y., & Kim, H. J. (2018). Use of CA15‑3 for screening breast cancer: An antibody‑lectin sandwich assay for detecting glycosylation of CA15‑3 in sera. Oncology reports, 40(1), 145-154.
2. Plasma separation using biomembranes: Homsy, A., van der Wal, P. D., Doll, W., Schaller, R., Korsatko, S., Ratzer, M., ... & De Rooij, N. F. (2012). Development and validation of a low cost blood filtration element separating plasma from undiluted whole blood. Biomicrofluidics, 6(1), 012804.
3. Hemolysis threshold pressure: Chen, P. C., Chen, C. C., & Young, K. C. (2016). Characterization of thermoplastic microfiltration chip for the separation of blood plasma from human blood. Biomicrofluidics, 10(5), 054112.
4. PES membrane bubble point: https://assets.thermofisher.com/TFS-Assets/LCD/brochures/Filtration-FAQs-June2013.pdf

The motive of our technology is to help our users with early-stage cancer diagnosis by screening for tumor biomarkers in their blood serum. If the diagnostic observation points to cancer, our customers can immediately seek the help of a physician for the next steps. The accuracy of this technology is aimed to be 97%, similar to the reported success in the research paper. 

There are no risks associated with our device, and it is very safe for our customers to use it without the need for any professional help. Along with our device, we also aim to provide our customers a user manual with clear instructions explaining how to use the device.

It was estimated that in 2020, about 225,800 Canadians were diagnosed with cancer and an average of 617 Canadians would be diagnosed with cancer everyday. Hence our primary goal is to serve Canadians who are more predisposed to cancer.

In five years, we aim to expand our team and branch to different countries and aim to serve at least half of the worlds’ population which is 3.8 billion. The current world population is projected to be at 7.79 billion as of July 1st, 2020. Also, the number of new cancer cases is estimated to be 19.3 million excluding skin cancer cases and an estimate of 10 million cancer deaths had occurred in 2020. 

InstaSerum’s impact goal is to serve billions of people around the globe and enable users to make informed decisions about the initial cancer diagnosis. Since serum biomarker testing is a developing diagnostic tool, our device could be potentially used for diagnosing diseases and health conditions apart from cancer. As a first step, we have planned to start testing and validating the product by Summer 2021 and start clinical trials by the end of 2021. By Fall 2022, we aim to have significant results from clinical trials and start the commercial phase. We plan to scale up and engage in B2B partnership with biomedical companies who manufacture diagnostic kits and also partner with clinical laboratories to use our product to draw samples. This will help expand our user base and launch our product in multiple nations, by adhering to all local and federal regulations.

We have identified critical key performance indicators (KPIs) that will help us align with our short- and long-term goals: 

KPIs for short-term goals: 

1. Qualitative parameters of the serum isolated from blood sample - E.g. Hematocrit value and hemolysis %.
2. Reproducibility of diagnostic test results using positive and negative test samples
3. Production cost

KPIs for long-term goals

1. Mass production costs and time
2. Number of people who use InstaSerum for diagnostic testing
3. Number of partners
4. Number of provinces/countries that we are able to commercialize our product

We are currently a team of four people. 

Sushmitha, a Ph.D. candidate in Chemical engineering at the University of Alberta, with 4+ years of experience in predictive data analysis, optimization of biochemical processes, and oil & gas. I am passionate about data, innovation, and social entrepreneurship. I am a problem solver! As an inquisitive engineer, I have the ability to find innovative solutions to every difficult situation. 

Robinpreet Dhaliwal is has a background in Chemical engineering. She has expertise in engineering and 3D printing design which are needed for production and manufacturing. 

Shruti Srinivas graduated with double Master's degree, with a specialization in Biochemical engineering. She has experience in working with polymeric membranes in the past, and she will assess the quality of the prototype and final product. 

Brindhi Amalraj recently graduated with a Masters' degree in Biological sciences. She has a strong biological background, and will assist with core technology research. 

As a strong advocate of EDI, we value having a diverse and inclusive team. When we have the resources to expand the team we will be partnering with CCDI - Canadian Centre for Diversity and Inclusion's policy regulation, to hire more employees. 

NO

Horizon Therapeutics is more focused on addressing the critical needs of the people impacted by rare and severe inflammatory diseases. Similarly, the goal of InstaSerum’s is to develop and commercialize a device that will help in diagnosing cancer at a very early-stage, thereby addressing the critical needs of people predisposed to cancer.  

Our team consists of people from various career backgrounds and we strongly believe in making our technology work. InstaSerum mainly believes in the phrase “Prevention is better than cure”. By taking part in the Horizon Prize, we look forward to showcasing our skills, and networking with experienced people from various backgrounds, who would give us feedback regarding our  technology. The prize money will help us in securing a patent for our idea, and when moving ahead with the product design, the money will also help us in securing the raw materials need to build our product. 

We are interested in partnering with both organizations and faculty members at the University of Alberta.  

The list of organizations are as follows: 

1. Nanostics Inc. 
2. Tricca Technologies Inc. 
3. DynaLIFE Medical labs

The list of faculty members are as follows: 

1. Dr. Rafiq Ahmad - University of Alberta