Upper tract urothelial cancer is a cancer that occurs in either the inner lining of the tube that connects the kidney to the ureter or within the inner lining of the kidney. Most cases of UTUC go unnoticed in the early stages as they display little or no symptoms. Upon receiving treatment in time, the 5-year survival rate is as high as 80%. However, due to it typically worsening before treatment due to various urothelial infections and metastasis of tumour cells, the 5-year survival rate is left with less than 50%. The prevalence of UTUC in Taiwan is the highest in the world, which is still on the rise till today. Causes of UTUC include smoking, high exposure to specific chemicals or Aristolochic acids, family history of diabetes, or long-term kidney dialysis treatment. It was known that patients under long-term kidney dialysis treatment have a higher chance of being diagnosed with UTUC. As Taiwan happens to also have the higher rate of kidney dialysis in the world, it then effectively explains the high prevalence of UTUC locally. Despite the need of early detection of UTUC, it is typically only diagnosed in the middle to late stages of the disease. The current detections of UTUC (CT scans, MRI, URE) do possess shortcomings in accurate diagnosis of early UTUC.
As there are obvious shortcomings in the existing UTUC detection methods (for more information, see Description), we strongly feel that there is a requirement for an auxiliary detection tool in detection of UTUC on the market. Therefore, we designed a product in this direction. Our team based off our project on the role microRNAs play in cancer, and designed a diagnosis kit named GotCha. We made use of elevated levels of specific microRNAs in blood serum in UTUC patients as compared to healthy individuals, and designed our kit to measure micro-RNA levels in the blood serum for UTUC diagnosis. We anticipate that our kit, GotCha, can bring a substantial contribution to the field of medicine, and effectively lower the risk of misdiagnosis of UTUC.
LDT 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:
1. Not costly: the cost of the diagnostics kit was effectively minimalised in order to cater to a larger population
2. 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
IVD market analysis
In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
The target audience of our diagnosis kit are individuals at high-risk of UTUC, which includes kidney dialysis patients, individuals highly exposed to specific chemicals and uncertified Chinese herbs, individuals with family history of diabetes. Through evaluation by their physician, individuals that fall under these categories can decide whether they want to opt for our test. All the patient has to do is to provide blood samples 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.
GotCha has minimal risk to the patient's body due to it being an in vitro diagnostic test, and has the below characteristics to cater to users:
1. Low cost so that a larger population can afford our product
2. Low risk as it is an in vitro diagnostic test so minimal harm is done to the user's body
3. Convenient as the hospital only has to retrieve blood samples from the user
4. Efficient as the results can be generated within hours
Product Position in Market
Our product GotCha is a LDT product, and an auxiliary tool or long-term tracking tool that can be used together with CT scans and MRI to be evaluated for UTUC diagnosis.
Studies have shown that in UTUC patients, specific micro-RNAs are expressed at highly elevated levels in the blood serum. As our product belongs to the category of blood test, it is ensured a lower risk of harm, and therefore very suitable especially for patients that are not able to or are reluctant to receive highly invasive diagnostic tests.
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 microRNAs 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. Beyond the LDT market, we hope to one day improve our product further in terms of convenience, and take our product out of the lab into common households as an IVD product. Through working closely with biotechnology companies, we anticipate even better versions of our product in the future.