Team:CSMU Taiwan/Implementation

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There are obvious shortcomings in the existing UTUC detection methods. Through consultations with experts in the field of urology(see Human Practices), we gathered that current detection methods such as CT scans and MRI have low accuracy or are unsuitable for kidney failure patients (see Description). From these sessions, our team strongly felt that there is indeed a requirement for an auxiliary detection tool in detection of UTUC on the market to increase chances of early UTUC detection.
Our team based our project on the role microRNAs play in cancer, and designed a diagnosis kit named "GotCha". We made use of elevated levels of specific micro-RNAs in blood serum in UTUC patients as compared to healthy individuals, and designed our kit to measure microRNA levels in the blood serum for UTUC diagnosis. For more information on GotCha, see Design.
With the support of our mentors (see Human Practices) we anticipate that our kit, GotCha, can bring a substantial contribution to the field of medicine, and effectively increase the chances of early detection of UTUC.

Target Users

The target audience of our diagnosis kit are individuals that need accurate diagnosis which is mainly those at high-risk of UTUC. This includes kidney dialysis patients, individuals highly exposed to specific chemicals and uncertified Chinese herbs, individuals with family history of diabetes (For more information, seeEntrepreneurship) Through evaluation by their physician, individuals that fall under these categories can decide whether they want to opt for our test.
Our product, GotCha, belongs to Laboratory Developed Test (LDT). All the patient has to do is to provide blood samples (3cc) through the hospital, and patiently wait for the test results to be generated in a short time. After which, their physician will evaluate the test results of our kit together with tests ran in hospitals, and make a more accurate diagnosis of UTUC.

Market Analysis

Up till today, Laboratory Developed Tests (LDT) mainly includes gene sequencing as well as detection of genetic diseases. These tests mainly use genetic sequences to determine whether one has genetic defects leading to genetic diseases, and they act as an auxiliary tool to genetic disease diagnosis. Through using test samples provided by the patient or hospital, the laboratory under the company will generate a set of test results for the patient. There are many ways this is done on the market, with samples ranging from blood serum to sweat, and from DNA testing to other substances present in body fluids.
In the above widely used forms of LDT tests mentioned, it is to be noted that these are generally expensive options in the field of diagnostics as LDTs are not covered by health insurance. This characteristic of most LDT tests on the market makes it difficult for individuals, especially those that are not financially stable, to opt for these options, and therefore cannot serve as much help in the field of diagnostics as they have the potential to.
Our team recognises the importance of inclusivity in product design, and therefore came up with GotCha which is:

  • Not costly: the cost of the diagnostics kit was effectively minimalised in order to cater to a larger population
  • Low risk: as our kit is an In Vitro test performed on blood serum samples, it minimises risks of causing damage to the patient's body
  • These characteristics of GotCha will assist it in thriving in the market by having an edge above the others in ways that greatly appeal to the target end-users.

    Usage of Kit

    A detailed explanation of the usage of the kit is found in our experiment protocol (see Protocol)
    The below is a brief outline of the steps needed for the usage of our kit:

    1. Unfreeze suspension containing functional magnetic beads
    2. Remove PBS buffer in functional magnetic beads suspension by isolating magnetic beads on a magnetic rack
    3. Add blood serum sample into eppendorf and wait for 30 minutes
    4. Wash content in eppendorf by isolating magnetic beads on a magnetic rack
    5. Add phi29 polymerase, phi29 polymerase buffer, and dNTP into mixture and wait for 2 hours
    6. Isolate magnetic beads on a magnetic rack and transfer remaining solution into another tube
    7. Add EDTA and Evagreen to the solution
    8. Collect fluorescence absorbance value
    9. Use table provided in the kit corresponding fluorescence absorbance value to microRNA amounts to derive amount of microRNA in blood serum sample

    Safety and Risk assessment

    End-user's safety

    Our kit involves a blood test, which we plan to extract 3ml of blood from the patient.
    The main risks of blood tests like our diagnostic test are low, mainly discomfort and bruising at the site where the needle goes in. These complications usually are minor and go away shortly after the tests are done.
    It is also to be noted that only certified personnels in blood tests are allowed to conduct this on patients.

    Technician's safety

    Handling our kit in the laboratory proves to be a safe option as well.
    It is required that the laboratory is LDT, GMP and ISO13485 approved.
    On top of which, technicians handling GotCha have to be thoroughly trained on Taiwan Food and Drug Administration (TFDA) standards.

    Potential Challenges

    The main potential challenge faced if implemented in the real world will lie in the handling of Streptavidin-coated magnetic beads involved in our experiment. As it is a relatively rare tool used in common laboratories today for disease detection, the mishandling of magnetic beads could potentially cause lowered accuracy in detection. For example, if magnetic beads are not completely isolated by the magnetic rack yet when the remaining solution is discarded during the miRNA isolation stage, this may lead to a lowered levels of miRNA detected by our kit than the actual amount.

    Future Aspirations

    We hope that our project can one day expand beyond the realm of auxiliary test, but replace current inadequate detection methods all together. As the study of micro-RNAs as diagnostic biomarkers has been increasingly popular in the last decade, we hope to continue improving our test kit to expand the range of micro-RNA concentrations detected, and effectively evolve into a universal tool of micro-RNA detection. Through working closely with biotechnology companies, we anticipate even better versions of our product in the future.