This year, XMU-China designed a device named Eye of Agamotto^TM（EA）that could applied in real-time cancer screening field by detecting biomarkers. The overwhelming advantage of EA is that it can overcome the drawback that some cancer detections could only be achieved in the big clinical lab by large and expensive equipments. That is, it could be more widely used in the community hospitals，especially in remote areas that are short of necessary medical resources.

We wondered if it would have a bright future in the IVD market,so we launched many associated Human Practices, including visiting specialists. Those specialists gave us some beneficial advice about the product-sale strategies, which was beneficial for our project’s further development. What’s more, we also visited the Community Health Service Center where our distributed devices could play an important role in testing lab. This business plan accurately analyzed and identified the target customers, and then identified the core competitiveness and competitive advantages based on the needs of the target customers. At the same time, combined with the market background, we reasonably applied the model into determining the marketing plan, and further designed an appropriate business model to show products' characteristics.

Market analysis

POCT is a subdivision of in vitro diagnostic instruments (IVD) industry, with the advantages of convenience and high speed, to achieve rapid diagnosis results around patients. Nowadays, POCT products have been widely used in hospitals, clinics and patients' homes abroad, and can be used to detect most of the conventional clinical indicators.

The population in China is really large, but its medical resources are quite various in different regions. Therefore, China is a huge potential market for POCT. At present, China's POCT market is still in its early stage of development, and it is expected that the overall market is still at the level of the European and American countries in the 1980s and 1990s. What’s more, the penetration rate in hospitals and other terminals is still low.

However, with the dual-wheel of "technology advancement& policy support" which drives the development of the industries, the demand for new disease’ detection and health examination continues to expand. On top of that, the benefits of three related policies, namely hierarchical diagnosis and treatment, the encouragement of domestic equipment and the special approval channel are optimized. The domestic in vitro diagnosis industry is growing rapidly at a rate of over 20%.

In 2017, the scale of in vitro diagnosis in China was about 50 billion yuan, but the per capita consumption of $4.6 accounted for only half of the world's average consumption. Therefore, there is still much space for development.

With the popularization of high technologies and new technologies in China, such as chemiluminescence and molecular diagnosis, the promotion of domestic policies including hierarchical diagnosis and treatment, as well as the domestic substitution could be expected in the development of domestic POTC industry in the future

STP analysis

In order to analyze the target customers and target markets of our products more accurately, we chose the STP model to determine the market orientation. We segmented the whole market initially, and then selected our target market, and finally orientated the target market.

SWOT Analysis

S

1. [Multiple Cancer Screening] Cancer-testing methods in the market are mostly single-cancer testing. But our products can be used to detect multiple cancers at the same time.

2. [Portable, rapid detection] Using POTC mode, the cancer can be directly detected by patients without the need for a central laboratory. What’s more, the product makes the detection fast and convenient. The test time is also much shorter.

3. [low threshold for operator's technical capacities]Using microfluidic technology, a set of automatic tumor marker detection systems have been established, which have lower technical requirements for operators.

4. [Overcoming the geographical limitations of diagnosis] Patients can upload data through app after testing, and doctors can analyze the uploaded data to get the diagnosis results, which overcomes the limitations caused by geographical distance between doctors and patients.

5. [Low cost] First, the cost of the instrument is lower, and then the cost of reagents and chips needed for a single test is lower.

6. [Patient with minor side effects] Testing requires only the collection of blood from patients, which minimizes the side effects of the test to patients.

W

1. [Detection accuracy is not enough] At present, the detection can only be used as a primary screening for cancer, but the accuracy of detection results needs further improvement.

2. [Need large amount of experimental data] Large quantities of experiments are needed to be carried out continuously in order to accumulate enough data for the database to provide more accurate diagnostic results.

3. [Specific cancer information is not available] Cancer can only be determined by testing, but the specific location of the cancer and other information can not be understood at present, and it needs follow-up testing to cooperate with.

4. [New products are waiting to be accepted by consumers] As a newly developed technology, it has just entered the market and needs a large amount of marketing in advance to help the product be recognized by consumers.

O

1. [domestic awareness of cancer detection is increasing]With the trend of urbanization, consumption upgrade and new health-care reforms, the demand for new disease detection and health check-up continue to expand, and consumers are willing to pay certain amount of money for it.

2. [the number of patients diagnosed with cancer continuesgrowing]The number of patients diagnosed with cancer is increasing year by year due to bad living habits, deterioration of living environment and so on. The demand for cancer detection is also increasing, and the demand for products will continue to grow.

3. [The support of domestic Policy] The three policies of "Graded Medical Facility & Encouraging Domestic Devices & Special Approval Channel" provide strong support for the development of products. For example, hierarchical diagnostic policy promotes the inspecting demand of grass-root medical institutions. However, the lack of resources in grass-root medical institutions provides opportunities for the sale of our products.

4. [There are no similar product in domestic market] There is no similar product in domestic market, and there is no competitor in China at present.

T

1. [There are many ways to detect cancer] Cancer testing has always been a hot research field in medicine. There are many theories that are feasible. There may be more convenient products in the future, which can exert disruptive impacts on the existing industry.

2. [Public perspectives of emerging testing technologies] At present, the public is more confident in traditional testing programs in large hospitals, and our products are new to them and may be difficult be accepted.

3.[competitions among international pharmaceutical giants]Some powerful international pharmaceutical companies also value the Chinese market and wish to join in the competition.

Michael Porter's Five Forces Model

From a macro perspective, we have analyzed the five forces in the industry that determine the scale and degree of competition from a macro perspective through Porter's Five-Force Model. The analysis five forces, namely the threat of potential competitors, the threat of substitutes, the threat between competitors in the same industry and the bargaining power of buyers and the sellers, are beneficial to the enterprises’ formulating corresponding strategies.

Our Agamotto^TM combines the design idea of ABCD system, which is the result of our research, with the concepts of POCT and IoT, and proposes a small and convenient design idea of microfluidic tumor real-time detection product.

In order to have a clear market positioning for the product, we adopted the 4P model to analyze it from the four directions like product, price, channel and promotion, and analyze its sales approach and profit model to form a preliminary business plan.

Product

Our product is a simple, fast and efficient cancer early screening products, which is using tumor markers in vitro detection technology, to achieve rapid and convenient cancer screening detection. We used microfluidic chip technology to establish a set of automatic tumor marker detection system. After obtaining the blood of the patients to be tested for treatment, we added the processed samples (serum) to the disk chip, and then put the chip into the matching detection hardware. The app could be remotely operated by user, and then a series of detection operations are performed independently by the instrument. After a series of biological reactions, the protein signal would be converted into fluorescent signal. App then converts the acquired signal to a visual and readable analysis report based on its internal machine learning sample database, and professional physician would make real-time diagnosis and treatment feedback through the communication platform built by block chain, which realizes point-to-point information sharing between user and doctor.

As for our product, not only it would greatly lower technical threshold of tumor screening, but also through APP can quickly transmit the testing results to doctors which could make remote diagnosis possible. At the same time, compared with previous cancer testing methods, our product will be with minimal side effects for patients, and the fee is much cheaper than before. Our product is dedicated to making cancer testing accessible to everyone.

● Lowered diagnostic threshold. Most of the experiments are carried out independently through the instrument, which requires less professional knowledge, so it greatly lower technical requirements of the experimental operators.

● Reduced demand for the space. Our product have been scaled down to a laboratory bench by technical reforms that used to require large instruments in lab, reducing the space constraints on in vitro testing of tumor markers.

● Reduced the impact of distance. Through our product, patients can upload the test results to physician's terminal through APP. Physician can diagnose by receiving information, which can help patients in remote areas get results as soon as possible, and also alleviate the unfair distribution of medical resources.

● Reduced injury to patients. Through our product, we only need to collect finger tip blood from patients that would minimize side effects on patients.

● Reduced the costs. The cost of our product, whether instruments or reagents, is much relatively lower than large-scale image testing, which can reduce economic burden of consumers and achieve the effect of regular screening.

Price

Our revenue mainly would consist of these parts: instrument sales revenue, experimental materials(like chips) sales revenue, medical services in platform revenue and advertising revenue.

First of all, we hope to continue to operate this project and improve it after iGEM competition. But at the same time, we also hope to properly reduce the price so that more people can do cancer testing under affordable economic burden with our product that is truly beneficial for people. So about pricing, we strive to strike a balance between cost and profit to support the sustained research and development of our project

Therefore, we will eventually sell the price 800 yuan based on the cost of product at present. If the subsequent expansion of production would be achieved, the cost may fluctuate downward due to scale effect. At the same time, for consumables such as chips and reagents, we launched subscription services that customers could choose to subscribe to the official website at a certain discount price and pre-select monthly purchases, after which the company will regularly send to customers by express delivery.

Place

Considering the high cost of opening stores offline, our main sales channels are completed online. Thanks to advanced and developed express delivery industry, intentional consumers can learn about our products through the official website where they could directly order instruments, chips and reagents needed. And then we would deliver them to customers by express delivery. At the same time, our APP will also launch mall services, users can choose to purchase products on APP. We will actively communicate and collaborate with the government to distribute the products to basic community hospitals and remote medical points.

Promotion

As a medical product, the most important thing is that we need to win the trust of consumers, so our marketing campaign focuses on how to let consumers trust and our products. Through a variety of publicity channels, we hope to achieve ideal that after-sale service chain that consumers can easily contact our customer service, and any questions can be timely feedback.

● Establish official website.

Official website is an important way for consumers to know our products. On official website, they can know the principle of our products, application methods, the obtained approval, the obtained certificate and so on. If the official website can provide enough information to make consumers trust, it will greatly promote the promotion of products.

● Put up posters or brochure in the hospital.

After a partnership with the hospital, we can design advertisements to be distributed in the hospital so that patients will have a great chance to notice our posters, understand our products and accept them.

● Use famous journals, magazines and newspapers to promote.

Regularly write articles on research progress and results, and contribute to well-known medical and innovative journals, magazines, newspapers and other publicity, thereby expanding the popularity of projects and earning consumer trust for products.

● Apply micro-blog account for publicity.

Through micro-blog information platform, we could communicate with our consumers. It can not only answer the public's doubts about product, but also upload some experimental videos to make consumers know more about how to use the product and to expand publicity through forwarding activities.

Above we use 4P model as a benchmark, combined with the characteristics of the product and expected business plan, the follow-up practice will be centered on this, But certainly with the changing market environment, our program will also be changed and adjusted accordingly in view of the actual situation encountered in various problems.

At present, based on the relevant literatures and the list of applied patents, we have not found a similar product, which means that our product pioneered a similar field of preliminary medical diagnosis. Since it is unique, it has more power to occupy the micro-medical field. Taking the first affiliated hospital of Xiamen university as an example, the detection platform for tumor markers commonly used in first-line clinical work, including ABBOTT I2000 automatic particles chemiluminescence immunoassay system, BECKMAN COULTER IMMAGE automatic specific protein analyzer, BIORAD MODEL680 enzyme-labeled instrument, BIO-RAD1575 microplate, JETLIA-962 type charging luminescence immunity analyzer, OLYMPUS fluorescence microscope, DML2000 gene hybridization signal detection system and other large and advanced detection equipments. According to the price list, it would cost above 900 Yuan for patients doing some specific clinical test items. But there is no denying that the test results are quantitative, which gives precise numerical values.

However, our product is of high quality and reasonable price. It just costs less than 1,000 yuan and can be reused by changing a new Chips after one test. For consumers with early screening needs, qualitative analysis of specific markers is sufficient to initially determine whether there is a possibility of cancer, which also could save money and time to complete the initial diagnosis, it is a perfect fit for community hospitals, small clinics and families with high risk of hereditary diseases.

INNOVAX is a wholly-owned subsidiary of Beijing Wantai Biopharmaceutical Ltd., which is committed to providing high quality and affordable innovative vaccines for human disease prevention. Since its inception in 2005, INNOVAX has successfully came the world's first vaccine for the prevention of hepatitis E (Yike Ning^®) into the market. Here we got engagement about our hardware design and OMVs vaccine.

In order to prove the feasibility of our project, we consulted the Chief Physician Weiwei Tang in Medical Oncology, The First Affiliated Hospital of Xiamen University, on August 23th. Dr.Tang appreciated it that our ideas are innovative and helpful. As for EA, Dr.Tang agreed with our intentions that we wanna make EA used widely among basic medical institutions especially in remote poor areas because of its convenient and practicability.

On September 30th 2018, we visited Mr. Su Mingluo, founder and chairman of Xiamen Kymem Membrane Technology Ltd, to have a deep discussion about information related to enterprises. He shared with us his experience of setting-up a new company, and rendered us prepared for drawing up business plans.

We visited Professor Zengfu Xue, deputy director of the Cancer Early Screening Diagnosis and Treatment Center, the First Affiliated Hospital of Xiamen University. We communicated with professor Xue about the next clinical trial plan of the detection hardware Eye of Agamotto, and reached a preliminary cooperation agreement. If possible, we could take the instrument to the lab in hospital, and use the patient's blood sample to verify the performance of the instrument, such as stability and sensitivity.

We visited Mr. Jianghong Wu, president of Xiamen Wenda technology LTD.As for APP part ,he gave some professional advices and technical guidance, like how to accelerate our convolution neural network recognition speed with collected increasing number of images cases, and how to link block them up between chain technology public health service database to serve the public better. In addition, Mr.Wu gave us a lot of advice on product promotion and profit model.

We visited Health Service Center of Datong Street, Tong’an District, Xiamen city. We learned about the development of tumor markers detection work in primary hospitals from director Zhan. President Zhan affirmed the future prospects of our instruments, believing it would solve problems such as "difficult access to medical services" in real life, to better provide more convenient medical and health services.

The Internet hospital of the First Affiliated Hospital of Xiamen university has officially opened, giving priority to online diagnosis and treatment of diabetes, hypertension, tumor and children asthma. As long as patients log in the Internet hospital at home, they can consult the health experts of the first hospital, so that your health problems can be solved without leaving the house. In the short term, Internet hospitals will launch mobile APP, WeChat and other entry points to create a "pocket hospital". We regard it as a goal within reach for our APP.

We visited laboratory of the First Affiliated Hospital of Xiamen University. Now with clinical blood test group, clinical biochemistry inspection group, clinical microorganism inspection group and other professional testing group, lab is equipped with first-class large test instrument. So here we learned those frequently-used and classical clinical detection devices or methods , like ELISA,CLIA and so on. They all maybe competitors for our products in the future. However, most of which are time-consuming , expensive and complex ,compared with EA.

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