Integrated Practics

In integration practice part, we integrated the work of each independent practice according to our understanding and thinking of the project. What we prepared to present is practical work aiming at the project and considering the integrity of the project

JACOB 2.0, like all other diagnostic or diseases screening medical products, must suits the conditions of various hosts and producers (e.g. hospitals and factories). Our out-of-lab, bi-directional research confirms that JACOB 2.0 is well prepared for the real market. We conducted interviews and sampled opinions as well as market need from both clinical laboratories and from the public. Project feasibility is confirmed and greatly improved as we went to BO-HUI company, in which we got helpful suggestions about the realization of biological processing and device design during the troubleshooting discussion session.We analyzed the market trend, also carefully investigated laws and regulations. From beginning to end, experts interviews are involved in our Integrated Practice. We believe that Human Practice is a crucial process of discovering and rediscovering meanings of our project, and through its in-person, authentic feedbacks we learn and improve.

As you can see, we mainly focus on three aspects

First, Markets research and Investigation
There are multiple steps in the pathway from biomarker discovery to use in clinical practice.^[1][2]
Despite the explosive growth in the biomarker research field and market, only a small number of the thousands of proposed biomarkers have been adopted into clinical practice.^[1]
In order to verify whether the market of biomarkers is right or wrong, we went to the hospital laboratory of Aerospace General Hospital in Beijing to do an interview about the clinical application of biomarkers , time consuming on the way and cost of hospital detection.
We know that biomarkers are of great clinical significance, but big hospitals barely have instruments for early disease screening.

To know how the potential patient thought about early detection and our JACOB 2.0. We release a questionnaire online, and got 470 responses which covered almost all the provinces in China. The questionnaire found that people have different views on an instrument that is suitable for detecting disease markers in the community, which facilitates early detection and early warning of various diseases, saves time and reduces the cost of detection.

Among the people who participated in the questionnaire, 84.5% had expressed a desire to know it, because of saving time, saving money, convenient to use, time is very precious, the early the know the disease, the more likely the will be cured. But there are still 15.5% of them thought it is not reliable.
But only 10.19% of the total lives in countryside, we thought the sample is not enough. So we went to remote areas of Guizhou province. We went deep into the local countryside to learn about the situation about early disease screening and treatment of local people. After that, combined with online research, we have summed up three major causes of poverty due to illness: high time cost, high money cost, low medical resources.

Second, experts talking and company visit
After completing the detailed investigation of detection biomarkers, we started to design our JACOB2.0. We have always been cautious about the realization of the project. We have carefully considered the suggestions of experts in the design, implementation and construction of the whole project.
At first, we presented and discussed the overall design of the project with professor Deng Yulin , such as the sensor part about the signal transmission part, we talked to our PI Lu Xuefei and asked for realization of the whole biosensor design.. In addition, we communicated and analyzed with Graduate Yang Yuanzhan graduate student on the specific implementation of biological experiments .For part of the chip design, chip and biological adaptation and instrument design problem has always been a part of our obsession, with PhD Li Yongrui and Graduate Likunjie to discuss and analysis.

we also went to the BO-HUI company, which has matured for the design and production of microarray , also talked with R&D staff of this company. In addition, in the market and application, we also interviewed and interviewed experts Xu Jiandong. And talk about marketing sections and the laws and regulations. Such as the need to show to the public unique and novel point but do not overturns the mainstream, and the need for relevant in vitro testing instrument and platform application and strictly comply with the required by laws and regulations, etc.

Third, laws and regulation study
Laws & Regulations research can re-examine whether our projects conform to national regulations and requirements.
By carefully reading “Guiding principles for Registration and Application of quantitative Detection Reagents for tumor markers”, we learned about the product performance indicators that conform to the regulations. We checked the minimum detection limit, detection range, precision, specificity of our project and try to make the various indicators of our project to meet the requirements and optimize our project.
At the same time, we also want to know how to do if our biomarkers products can be put on the market, so we checked the "Registration Management method for in Vitro Diagnostic Reagents," and learn that the specific indicators should be determined according to the specific markers. And the product standard formulated by the applicant shall not be lower than the national standard or industry standard.
Click here to see our report detail about laws and regulations

Reference：
[1].N. G. Frangogiannis, The Journal of Laboratory and Clinical Medicine, Transl. Res., 2012, 159, 197–204.
[2].N. Rifai, M. A. Gillette and S. A. Carr, Nat. Biotechnol., 2006, 24, 971–983.