Introduction
During our journey to conquer Project DIAS, improve it and build it, communication with stakeholders was crucial. We visited diagnostic centers in order to build our diagnostic tool based on their equipment and to learn the conditions that a diagnostic methodology must have in order to be added to the annual screening. In addition, it was very important for our team to communicate with doctors and oncologists who are closer to patients and improve our tool according to their needs, while we were in constant communication with the academic community. Additionally, we contacted industries to ascertain that our diagnostic device can be easily produced at a low cost and given to diagnostic laboratories. Finally, we reviewed the regulatory framework for in vitro Molecular diagnostic tools and contacted start-ups to improve our Business Plan. But the most important activity was the contact with the public that confirmed to us their desire to do the diagnostic test we recommend so that in case of cancer they have more chances of survival. Our team promised that will happily devote as much time as needed to make DIAS come true!
Academic Community
During our team's journey into the world of Synthetic Biology, the Aristotle University of Thessaloniki and the Academic community were fellow travelers. The role of the University Authorities and the professors was particularly important for the development of our project. They supported us financially and materially by providing labs and spaces for our team meetings, while professors played an important role in improving our tool to be properly prepared for future use in the market.
• Rector of AUTh, Dr. Papaioannou Nikos | 11.05.2022 •
Throughout our journey up to the final stage of the competition, the role of our university was determined. The Aristotle University of Thessaloniki (AUTH) has been participating in the iGEM competition since 2017. Thus, the entire university community has understood the benefits, knowledge, and experiences that a research group gains from participating in such a competition. On April the Rector of AUTh told us that he would provide the money for the team's registration in the competition. In addition, he permitted us to freely use the university premises for the organization of social activities and our group meetings, and the laboratory premises for the implementation of our project. On 11.05.2022 the Rector scheduled an appointment in his office to meet all our team members and congratulated us on how we worked together. He also mentioned that the secret of success in such projects is interdisciplinarity. There we had the opportunity to present our project. He wished us all the best in the experimental procedures and told us that he was proud of our team. Also, he expressed his desire to find our diagnostic tool at his neighborhood diagnostic center in a few years. He also expressed interest in being one of the first to do this test because he mentioned how important early diagnosis is in diseases like cancer and how much it could help increase survival rates. Finally, he promised to support our effort to push the tool from the lab to the market as he believes that this tool could help society.
• Vice-Rector of AUTh, Dr. Stylianidis Efstratios | 12.05.2022 •
On Thursday 12.05.2022 our team met the Vice Rector Dr. Stylianidis Efstratios in his office to present the DIAS project. First of all, he congratulates our team for the idea to try to solve the problem of late diagnosis for such a common and mortal cancer. In addition, he shared with us a personal story from his family where he emphasized that the diagnosis of lung cancer was made at the 4th stage and unfortunately after 3 months his cognate died. Thus he said...
"I wish there was such a diagnostic tool at that time, so that there was an early diagnosis and there were more chances of survival"
Since Mr. Stylianidis is the Vice-Rector for Research and Education and in charge of ELKE, the body that manages the financial transactions at the University, he helped us with the acceptance of the sponsorships and their management to procure the reagents for the implementation of DIAS tool. Finally, he told us that it is very important to strongly continue the research effort so that this diagnostic tool goes to the market. Finally, he recommended our team contact the Office of Technology Transfer, AUTh to explain to us the steps we need to follow in order to register the rights of the project and market it.
• Dr. Fatouros Dimitrios, Professor in Pharmaceutics, AUTh | 19.01.2022 •
On Wednesday 19.01.2022 we scheduled an online meeting with Dr. Fatouros who is a professor in the Department of Pharmaceutical Technology at the School of Pharmacy, AUTH. Specifically, his research interests are self-micro/nano-emulsifying drug delivery systems and Nanotechnology. Initially, we presented our idea to him citing the desire to achieve an early diagnosis of lung cancer. He was excited and emphasized that he considers early diagnosis very important to increase the survival rates of such diseases. He also found that to implement this project and to prove its accuracy and effectiveness, a lot of money is required. So he advised us to pay close attention to fundraising so that we can reach the goal within our budget to buy reagents and equipment.
In addition to these, we reported to Dr. Fatouros that a representative of the Platon diagnostic center, which we visited on 10/1 emphasized that a diagnostic tool to be added to the annual blood tests should be easy to use and cheap. The miRNA, which we chose as a biomarker, is found in small amounts in patient samples, so an amplification method must precede it. We explained to Dr. Fatouros that PCR cannot be used because it is an expensive technique and requires specialized personnel and equipment. So he suggested that we better study microfluidic technology and see if it can be combined with our chosen CRISPR/Cas technology. So our team, after this meeting, looked at the literature and with the help of the advisors came up with the design of the microfluidic chip which is cheap because it can be manufactured with 3D printing, has a low detection limit for the biomarker due to the creation of drops and facilitates the diagnosis process without requiring specialized personnel. For more information visit: Project Description
• Dr. Papadopoulou Lefkothea, Professor of Pharmacology, AUTh | 30.05.2022 •
On Monday 30.05.2022 our team held a meeting with Dr. Papadopoulou in her office. Initially, we presented to her the idea of developing a molecular diagnostic tool for lung cancer, and then we described in detail our experimental design for the implementation of the project. She was enthusiastic about our idea and emphasized that she feels proud that young scientists decided to deal with the diagnosis of such a serious disease. Dr. Papadopoulou has been particularly concerned with the experimental processes of protein production. So, regarding our Project, she advised us to create a plasmid to produce Cas13a protein in vitro and add SUMO protein by cloning. She explained to us that SUMO enhances protein production in E. Coli bacteria with improved stability and solubility. The soluble property of the produced protein facilitates the purification and isolation procedures and helps to produce large quantities to perform our team's experiments. Following her advice, we designed the new plasmid (BBa_K4170016). Finally, Dr. Papadopoulou is the safety and quality manager of the laboratory and she advised us on the protective measures to follow when conducting the experiments. For more information visit: Safety
• Dr. Kallergi Galatea, Assistant Professor in Biology, University of Patras, and Dr. Kalogianni Despina, Assistant Professor in Chemistry, University of Patras - PIs of Patras Medicine 2022 team | 03.05.2022 •
On 03.05.2022 our team and our partners, Patras Medicine 2022 team, scheduled an online meeting with Mrs. Kallergi and Mrs. Kalogianni and our PI, Dr. Vizirianakis to present our project to them. After the presentation, they congratulated us on our innovative idea, our project design and our working method. Furthermore, they said they are particularly pleased that both teams are working on molecular diagnostic tools for the early diagnosis of lung cancer. They believe that our project can have an impact on the public and with the right steps, it could easily be sold in diagnostic centers for the annual screening of patients for lung cancer in a few years.
• Mr. Chatzitaki and Mr. Monou, PhD Candidate in Pharmaceutical Technology, Department of Pharmacy, AUTh - Advisors of our team •
One of the most important milestones for the final design of our project was the meeting with our advisors with Ms. Chatzitaki and Ms. Monou who are PhD Candidates in Pharmaceutical Technology at the Department of Pharmacy at Aristotle University of Thessaloniki. We presented to them our general idea for our diagnostic tool, and we gladly embraced their comments and their suggestions for improving our project. Aiming for the usage of microfluidic technology for droplet generation purposes, they proposed to us to manufacture it through 3D printing techniques. They helped us with proposing a flow-focusing channel geometry for droplet production and gave us insights about the steps that we needed to follow to accomplish the fabrication of a functional device. In addition, they guided us with information about the Digital Light Projection technique and the appropriate way for device testing with pumping systems.
Diagnostic Centers
From our first steps in designing our concept to the start of experimental procedures, our team felt it necessary to reach out to diagnostic centers that will be the future users of the DIAS diagnostic tool. So we contacted two of the largest networks of diagnostic laboratories in Greece to confirm that the diagnostic test we propose can be implemented and used by the diagnostic centers based on their equipment and personnel. In addition, we discussed the conditions in order to include this diagnostic test in the annual preventive screening of smokers and people aged 40 and over, who are the risk groups.
• PLATON DIAGNOSIS S.A. | 10.01.2022 •
On Monday 10.01.2022 our team visited the headquarters of the chain of diagnostic centers PLATON DIAGNOSIS S.A., Greece. After a tour of the microbiological laboratories where the public examinations are carried out, a meeting was held with the Board of Platon Diagnosis S.A. We first presented the project and described in detail the diagnosis methodology and the steps of the diagnostic process we propose. Dr. Athanasoula Anastasia, MSc, Biopathologist, assured us based on her experience that RNA extraction can easily be performed from the blood sample for several samples at the same time before the use of our tool. In addition, she said that it seemed to her a simple technology and she believes that it can be easily adapted and applied in diagnostic centers.
Also, after a discussion, the president Mrs. Karkali Christina emphasized that in order to include this diagnostic technique in the annual blood tests, it should be cost-effective to be supported by the Authority of Health of each country. So we chose to use a Microfluidic chip to avoid expensive amplification techniques that would be necessary to amplify miRNAs in blood so that they can be detected.
Also, we made sure to manufacture the Microfluidic chips with 3D-printing which is considered a cheap technique. Finally, we cloned the sequence of the Lbu-Cas13a protein so that we can easily and cheaply produce it in large quantities from stock.
Finally, in our meeting, Mr. Chalkiopoulos proposed that once the construction of the diagnostic tool is completed he would make the microbiological laboratory available to us for the first clinical tests. In this way, he emphasized how important he considers it to be to create tools for the early diagnosis of cancer and to add them to the annual screening. So, we promised that we will work hard and that we hope to meet again soon to present them the successful results.
• LABnet Medical S.A., Greece | 27.05.2022 •
On Wednesday 27.05.2022 our team scheduled an online meeting with Dr. Chatzopoulou Fani, Director of Molecular Analysis Laboratory at LABnet Medical S.A. Greece. Dr. Chatzopoulou has many years of experience in the field of molecular diagnostics used in microbiology laboratories. In addition, the LABnet group of medical laboratories is the second largest group of laboratories in Southern Europe. During the meeting, we presented in detail the methodology used by the DIAS diagnostic tool. Ms. Hatzopoulou recognized the innovation of our tool and emphasized that it is quite simple to use and cheap. Thus, she stated, that the DIAS diagnostic tool can easily be used by diagnostic centers that do not have specialized personnel and equipment. He also assured us that all diagnostic centers have a fluorescence microscope that is used in the final stage of this diagnostic procedure. She concluded that these features of our project are suitable for it to be sold in all diagnostics centers in order to offer this cancer test to the public.
In addition, she explained to us how important the early diagnosis of cancer is for successful treatment and shared with us her thought that if molecular diagnostic tools are developed to prevent all types of cancer, mortality will be greatly reduced.
Finally, Dr. Chatzopoulou found that some of the reagents used in our methodology, such as Lbu-Cas13a are stored at -80°C. So she informed us that some laboratories do not have such freezers. So she suggested to us to lyophilize the reagents and in this form provide them to the diagnostic centers for each test. After that, our team researched lyophilization protocols and added this specific procedure to future planning for final disposal to diagnostic centers.
Doctors
During the steps we followed to successfully create the DIAS diagnostic kit, we realized that important stakeholders are the doctors and oncologists who will refer patients to do our test. We were honored to be able to talk to doctors who are doing their best to save patients' life, every day. We listened carefully to their feedback to improve our diagnostic method so that it can be safely offered to the public.
• Department of Pulmonology, General Hospital of Thessaloniki “G. Papanikolaou” | 29.03.2022 •
On Tuesday 29.03.2022 our team visited the General Hospital of Thessaloniki “G. Papanikolaou”. There we had a meeting with Pulmonologist and Associate Professor of Pulmonology, AUTh, Dr. Spyratos Dionysios, and with the Pulmonologist and Emeritus Professor at the Department of Pulmonary Medicine AUTh, Dr. Porpodis Konstantinos. We presented our diagnostic method and explained that we propose to add this diagnostic test to the annual screening for lung cancer. Initially, they congratulated us for our effort and wished us success in creating our tool. Then, they shared with us that in the majority of clinical cases of lung cancer, the diagnosis is carried out at the final stage where the tumor cannot be surgically removed. This is how patients die. They also told us that this type of cancer metastasizes to vital organs, emphasizing how important it is to treat it early before it reaches the final stage. In conclusion, they said that an annual diagnostic test could have a great influence on increasing survival rates since it would be able to detect the cancer tumor in the early stages when the patient is asymptomatic.
In addition, they emphasized that we should be very careful that the diagnostic tool has accuracy and specificity in order to avoid false positive and false negative results. Thus, we explained to them that the CRISPR/Cas13a technique we chose has high precision in the connection with the biomarker and does not present off-target effects. We also did experiments using different miRNA molecules and proved that only the miRNA we selected activates the CRISPR/Cas13a system and fluorescence is produced. Finally, in the future, we aim to apply our diagnostic technique to blood samples of lung cancer patients to certify the accuracy of our method.
• Dr. Vachtsevanos Konstantinos, MD, DDS, PhD, Professor, and Head of Oral Surgical Resident at the General Hospital of Thessaloniki “G. Papanikolaou” | 11.04.2022 •
On Monday 11.04.2022 our team had an online meeting with Dr. Vachtsevanos Konstantinos. In this meeting, we announced our mission to create a diagnostic tool for the early detection of non-small cell lung cancer. Dr. Vachtsevanos was excited by our innovative idea and expressed his enthusiasm for our project design. He also said he hopes more and more young scientists will get involved in tackling the deadly disease. He confirmed that in such cases early diagnosis is essential to follow a successful treatment. He also said that when the cancer diagnosis is delayed, the treatment options are reduced.
During the interesting discussion, he suggested that we contact the Ministry of Health as soon as we finish building our tool to inform the Medical community. Finally, he informed us that oral cancer is too slow to be diagnosed and asked us to create a corresponding tool for its early detection. In fact, he promised us that he would help us in our search for suitable biomarkers.
• Iakovidou Chrysoula - Maria, Md, MSc(c) in General Surgery | 14.09.2022 •
On Wednesday, Doctor Iakovidou Chrysoula-Maria visited the Aristotle University of Thessaloniki and met our team in the lab. We started the discussion by presenting the methodology that our team uses in the diagnostic kit and our future steps. Then, we showed her some results that prove our diagnostic method. She expressed her enthusiasm for the implementation of our idea and confirmed the importance of early diagnosis in cases of cancer. He also found that it is a simple and cheap technique that could easily be used by diagnostic centers while adding that it will have a great impact on the public for the proper prevention of the disease. But she emphasized that an important future step will be to prove the functionality, accuracy and specificity of our tool in the analysis of blood samples. After that, she will be able to trust our diagnostic technique and recommend it to her patients.
• Avgeros Chrysostomos, PhD Candidate in Precision Medicine, School of Medicine AUTh | 18.01.2022 •
From the first steps, our team contacted Mr. Avgeros, PhD Candidate in Precision Medicine, because he works at the same university and deals with molecular diagnostics. So his feedback was very important for the development of our project and for its detailed design. After listening carefully and in detail to the planning of our project, he congratulated us and pointed out the importance of molecular diagnostic tools in reducing cancer deaths.
Then, he advised us to validate our chosen biomarker and confirm by bioinformatic analysis from databases that this miRNA is present in the largest percentage of early-stage lung cancer patients. He also suggested us a corresponding analysis to determine if our biomarker is overexpressed in other diseases as well. Thus, a differential analysis of several samples was performed with the help of the R programming language and the correlation of miRNA with lung cancer was found. In addition, the team added to their future plans to study a combination of biomarkers to ensure greater specificity.
Industries
From the first steps of the development of the DIAS diagnostic tool, our team considered it very important to get in touch with companies and industries in order to determine if the tool it proposes is feasible to manufacture in the market. We were also interested in confirming the value of our diagnostic methodology and whether industries would be willing to invest time and equipment in order to manufacture this diagnostic kit for the early diagnosis of lung cancer. The team believed that securing the support of large companies to produce our tool would bring us closer to our dream of giving the whole world the opportunity to perform this test.
• Research Genetic Cancer Center S.A. - RGCC Group | 15.04.2022 •
RGCC Group is a specialist medical genetics company, established in 2OO4 with headquarters in Switzerland. We are experts in developing and providing personalized cancer genetics tests for doctors and patients, and testing tumors for sensitivity and resistance to chemotherapy treatment and a range of natural substances. We are actively involved in pharmaceutical research and development. Our facilities are equipped with the most technologically advanced equipment and specialized software for data analysis. On Friday 15.04.2022 we visited the lab facilities of RGCC Group in Florina, Greece. First, we joined a tour of the labs and industry. There we saw the equipment they have and it was confirmed that the reagents used by our technology can easily be produced there.
Then, we were taken to the meeting room where we had a very interesting discussion with Dr. Papasotiriou Ioannis, an Oncologist and founder of RGCC Group. He explained to us that one of the biggest problems in treating cancer is that patients in the early stages have no symptoms. This leads to delayed diagnosis and doctors end up at a dead end because they cannot proceed with surgery nor do they have many treatment options and the progression of the disease is rapid. He also emphasized that while chemotherapy can be applied in the final stages, it actually weakens the immune system of the patient, who is susceptible to infections. In both cases the result is death. So he agreed with the idea and direction of our team as he said that he considers it particularly important to add such tests to the annual screening of the population as this would have a huge influence on the successful treatment of cancer. In addition to his advice, he offered to be a key sponsor of our effort as he believes that truly bringing such diagnostic tools to market could have an impact on public health and should be done immediately.
On Tuesday 12.07.2022 our team visited again the lab facilities in Florina to do some test experiments to certify that our technology works in an industrial laboratory. There we did troubleshooting about the cloning method with Mr. Apostolou Panagiotis, Supervisor of their lab. In addition, he suggested that we can organize the reagents in the form of kits and thus supply them to the diagnostic centers so that we can be sure of their quality. Finally, he suggested automating the diagnostic device and including a microfluidic chip and a camera that will detect the fluorescence. So, as he said, diagnostic centers will be able to easily install this device in their laboratories and procure consumable reagents for each examination. After this discussion, the team proceeded to design the diagnostic kit and in the future will study the hardware to create the diagnostic device.
• KARABINIS MEDICAL S.A. | 4.10.2022 •
On Tuesday 4.10.2022 our team scheduled an online meeting with Mr. Stamatiou George, Business Development Director of KARABINIS MEDICAL S.A., and Mrs. Karioti Myrsine, Executive Assistant to President and Managing Director of KARABINIS MEDICAL S.A. After the presentation of project DIAS they expressed their enthusiasm and congratulated our team for our innovative tool. They explained to us that the company they work for is active in the field of diagnostic devices and that they would definitely be interested in future collaboration. In addition, they explained to us how important it is for Public Health to have such special diagnostic techniques that make early diagnosis easy and cheap. They recognized the impact of our project in increasing survival rates. Finally, they congratulated our team for the flawless design of the project, for the cost analysis, and for the business analysis.
• ELPEN Pharmaceutical S.A. | 22.07.2022 •
On Friday 22.07.2022 we contacted Mr. Vakalopoulos George, Corporate Communication Associate at ELPEN Pharmaceutical S.A. After the detailed presentation of the diagnostic techniques we use, Mr. Vakalopoulos emphasized that biotechnology products are the future of Diagnostics. He told us that ELPEN Pharmaceutical S.A. aims to create medical devices that will upgrade people's standard of living. Thus, he commented that our own diagnostic tool will be very important for the prevention and diagnosis of lung cancer and will make it easier for oncologists to choose the treatment. Also, based on the cost analysis of our device and based on his experience, he said that it would definitely be able to be carried out annually and that it could easily be produced by an industry. Also, he congratulated us on our organizational skills and our professionalism. Finally, he asked us for printed material with the description of our project to study it.
After this discussion, he contacted us and told us that our project accepted the evaluation of their company with the highest rating and that they will finance us as sponsors because they believe in our innovative idea. They also expressed interest in future collaboration on the production of the DIAS diagnostic device.
• iQVIA | 18.05.2022 •
On Wednesday 18.05.2022 our team had an interesting meeting with Mrs. Kalogeropoulou Maria, Sr Consultant HTA - Consulting & Services at iQVIA. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry dedicated to creating intelligent connections that deliver unique innovations and actionable insights. Their slogan is "Accelerate innovation for a healthier world." Firstly, we presented our project and the aim of our team. She was excited about our diagnostic tool. In fact, she shared with us that her mother died of lung cancer. He told us that she believes that such a diagnostic if added to annual blood tests will save many people's lives. She wished us good luck in the competition and told us that he hopes that the experimental procedures will be successfully completed so that it will be released on the market immediately and that everyone will be able to take our test at their nearest diagnostic center.
Finally, she emphasized that she will contribute in any way she can to our effort by putting us in touch with companies that can help us with clinical trials in the future, and by pollinating diagnostic centers that collaborate to promote our technology.
Associations - General Public
Our team wanted from its first steps to get in touch with the public since they are the end users of our DIAS diagnostic tool. We met clubs and people of all ages from different venues. They all enthusiastically told us that they would love to see our diagnostic tool on the market immediately, and shared their personal cancer case stories. They also shared their fears about more complicated tests such as biopsy or MRI, confirming that blood tests are simple and can be done every year. Finally, we assured them that the diagnostic test will have a low cost. They thanked us and wished us good luck in the competition.
• Pharmaceutical Society of Thessaloniki | 24.05.2022 •
On the 24th of May, we presented our project DIAS to the president of the Pharmaceutical Society, Mr. Evgenidis Dionysios, Pharmacist, and to the vice-president Ms. Sidiropoulou Anna, Pharmacist. They congratulated us on our idea and they recognized the value of our diagnostic tool and the impact on patients, who suffer from lung cancer. Mr. Evgenidis emphasized that lung cancer presents cellular and genomic heterogeneity, so it's very difficult to treat it. For this reason, it is important to approach the disease a stage earlier and to focus on early diagnosis so that the available treatments can be used more effectively. Also, Ms. Sidiropoulou found that our diagnostic tool, which we propose to add to annual blood tests, has a significant effect on smokers and people with a family history of cancer. Based on their knowledge, they confirmed the value of the DIAS diagnostic tool and indicated that they hope to soon be able to perform this test. In addition, they expressed a desire to be among the first volunteers to give a blood sample for the clinical trials.
• Thessaloniki International Fair | 10-18.09.2022 •
The International Fair of Thessaloniki takes place every year in September in Thessaloniki and is the largest exhibition in Greece and the Balkans. This year, on 10-18.09.2022, the 86th International Exhibition of Thessaloniki took place. Guided by the new reality in the world economy, the changing environment in the fields of health and energy, but also the galloping developments in technology, the 86th TIF came to declare its timeless presence and contribution to the life of the country, faithfully serving its multidimensional character. This year, 212,000 people, including members of the government, visited the TIF. The new government policy of our country for the next year was also presented in this report. There our team had a stand in the Pavilion 14 of the exhibition, the "Academia" Pavilion. Representing the Aristotle University of Thessaloniki, our team came into contact with visitors of different ages where we described how the DIAS diagnostic tool works and how we propose to add it to the annual blood tests of the population for the diagnosis of lung cancer in the early stages. Most showed great enthusiasm and confirmed the value of our diagnostic tool while sharing personal stories of relatives who died of cancer due to late diagnosis and limited treatment options. They encouraged us to continue the research and develop new diagnostic tools for other types of cancer as well and promised us that they will be among the first to test our test in a diagnostic center in the future.
In the exhibition, in addition to describing our project and talking to the public about cancer, our team prepared a short anonymous questionnaire of two questions to find out if our diagnostic tool is applicable and if the population is ready to take such a blood test for cancer.
The questionnaire questions were:
- How important do you consider the early diagnosis of lung cancer for the successful treatment of the disease? Responses were rated on a numerical scale from 1 to 5.
- Would you take blood tests to see if you have lung cancer? Here they answered yes or no.
Finally, before submitting it, the participants gave their approval for the statistical processing of their answers by the iGEM MetaThess team.
The questionnaire was answered by 1,387 adults and the results showed:
The questionnaire was answered by men and women of all ages and the overall results showed that the public considers annual screening for diseases such as lung cancer important and would be willing to have such an examination at diagnostic centers. In addition, they emphasized that blood tests are routine tests and are done quickly and non-invasively, while CT or magnetic resonance imaging, which is used for diagnosis today, usually scares them, they consider it painful and they avoid it.
Our questionnaire, among others, was answered by the Minister and the Deputy Minister of Education, the Rector and the Vice-Rector of Aristotle University of Thessaloniki and by our partners Patras Medicine 2022 team.
• Greek Medical Association | 18.09.2022 •
On Friday 18.09.2022 we contacted the Greek Medical Association. Firstly, we presented our diagnostic tool DIAS and we explained that in this way we can achieve early diagnosis to increase the survival rates. They validated that prevention and early diagnosis could dramatically change cancer mortality rates. For this reason, the Greek Medical Association, this year launched a campaign to inform the public about the importance of lung cancer prevention and to protect the population from environmental pollutants and smoking. Finally, they wished us good luck in the competition and they congratulated us on our project.
• European Commission in Greece | 22.09.2022 •
On Tuesday 22.09.2022 our team visited with our partners Patras Medicine 2022 team the European Commission's office in Thessaloniki, Greece. After the project presentation, they congratulated us on our project because they emphasized that they consider it important to have easy-to-use diagnostic devices on the market and in diagnostic centers that will contribute to the early diagnosis of lung cancer. In addition, they told us that they looked at the lung cancer mortality statistics published by the World Health Organization and were disappointed. So, they were happy that there are research groups of young people trying to find a solution to such serious health problems. We were suggested after the manufacture of our diagnostic device to organize an information campaign mainly for high-risk groups such as smokers or people with asthma. Finally, they urged us to look up the European regulation related to in vitro diagnostic tools such as ours to see the approval process. Indeed, after this discussion, our team arranged a meeting with a representative of the EMA (European Medical Agency) on October 1st for relevant information.
• Cancer Prevention Research Group in Greece (CPRG) | 2.10.2022 •
During our journey from the first steps to the top of DIAS, our diagnostic tool for lung cancer, we collaborated with the Cancer Prevention Research Group in Greece (CPRG). In our first meeting, we presented our project and we took their feedback. More specifically, Mr. Athanasiou Efstratios, President of CPRG Group in Greece, congratulated our team on our innovative idea and he validated the value of early diagnosis with a quote from Hippocrates, the father of modern Medicine, who lived in Ancient Greece. He said, “It's better to prevent than to treat a disease.”
On the 2nd of October, we organized in collaboration with the CPRG Group and the iGEM Patras Medicine 2022 team a webinar about lung cancer. In the webinar, there were some greetings from professors and speeches about the epidemiology of lung cancer and its types started. Then Mr. Velissariou Hlias and Mr. Mpochalis Eleftherios presented the project of the Patras Medicine 2022 group and the diagnostic methods used today. Finally, Mrs. Gouliou Ioanna and Mrs. Kosmidou Maria presented the project of our team and the therapeutic methods used to treat lung cancer. The webinar was attended by approximately 300 people including doctors, researchers and journalists. You can see the detailed webinar program here: PDF 1
At the end of the webinar, the audience's questions were resolved and it was discussed how important prevention and early diagnosis are in diseases such as cancer. It was understood by the public that if the cancerous tumor is detected early and it has not metastasized then surgery can save the patient. We received a lot of positive feedback from the public which confirmed that there is a need for in vitro diagnostic tools that can easily, quickly and cheaply diagnose cancer. We are proud because many believed in our ideas and expressed interest in being among the first to do this diagnostic blood test. Finally, they wished us all the best.
Regulatory Entities
Very important to build an integrated diagnostic tool that can be used by diagnostic centers in the future was to investigate the regulatory framework for in vitro diagnostics tools. We were also interested in learning the process and the documents we should submit in order to have our diagnostic tool approved by the relevant organizations.
• National Organization of Medicines | 3.08.2022 •
National Organization for Medicines (EOF in Greek) is the regulatory organization in Greece for medicinal and pharmaceutical products for human and veterinary use, food supplements, medical aids and cosmetics. EOF in line with the regulations of the European Union evaluates and approves new safe and effective products. Among its mission is the control the production of in vitro diagnostic products before they are widely implemented. Communication with this sector was therefore imperative in order to ensure the safety and effectiveness of our diagnostic tool and to thoroughly investigate the bioethics of our project.
We performed an insightful zoom meeting with Ms. Nikokavoura Aspasia, Chemist and Employee of the Health Material Evaluation Department of the National Organization for Medicines. We found out that our diagnostic is a medical technology product and for such products, there has been new legislation established (Regulation 2017 746) that has facilitated the approval process so that it is carried out more directly, including all stages of the product. All products are classified into three categories according to their specialization and ours is subject to category C. Conducting specific experiments to ensure the effectiveness of the tool is strictly defined for each category. We were also informed that the exact completion of a technical file for our product is mandatory. This file should contain detailed information not only about the process and the production stages, but also preclinical, and clinical data and information about the stability and specificity of the product. After the file is completed with all of the above information, it has to be sent to a notified body and that is the last step of the approval process.
• European Medical Agency - EMA | 1.10.2022 •
On Saturday 1.10.2022 we scheduled with our partners iGEM Patras Medicne 2022 team, an online meeting with a Representative of the European Medical Agency (EMA). Firstly we described the mechanism that our diagnostic tool uses as well as the process that a microbiologist must follow to use the DIAS tool and obtain the diagnostic result. The EMA Representative informed us that in 2021 the law 2017//0746 concerning medical devices for laboratory tests considered IVDs (in-vitro Diagnostics) was amended to be classified in the category of Companion Diagnostics. In order to file and get our tool approved for this category, we would have to associate it with a chemotherapy drug for lung cancer. So we searched the literature and suggested that in cases where our diagnostic test is positive, the patient should be referred for more specialized tests and once the existence of the cancerous tumor is established, cis-platin and paclitaxel should be administered to shrink the tumor. He also told us to read the medical device legislation 2017/0746 carefully and follow the steps outlined there. Finally, he recommended us to contact the Ministry of Health and more specifically the HTA - Health Technology Assessment to inform us about the process we need to follow in order to add the DIAS diagnostic tool to the annual screening.
Entrepreneurship
During the design of the DIAS diagnostic tool, we wanted to explore the needs of the market for such diagnostic devices in order to adapt our tool accordingly. We contacted founders of Start-up companies to help us with Intellectual Property to advance the patent describing our diagnostic methodology to the market. We were also interested in discussing how we should approach investors to fund our endeavor as well as industries that might be interested in producing our product.
• Meeting with Mr. Kourtesis Dimitrios, Co-Founder of Ideas Forward IKE | 2.06.2022 •
On Thursday 2.06.2022 we met Mr. Kourtesis Dimitrios at a University event related to Entrepreneurship and Start-ups. First of all, we described our diagnostic technology of our DIAS diagnostic tool. He congratulated us about our innovation idea that concerns such a serious disease as lung cancer and can save human lives in the future. In addition, he found that our diagnostic tool appeals to a large part of the market as there are many groups that are at increased risk of developing this disease and should be screened every year. So, he emphasized that this is a strong feature of our product to approach the interest of an investor. In addition, he said, a very important advantage for any diagnostic device is that it can diagnose many types of cancer and is easily adaptable. So, after this discussion, we redesigned the cloning strategy and perfected it so that in the future one could simply use a different primer to detect any RNA molecule. We added to our future goals to search for RNA molecules that could be used as biomarkers for the early diagnosis of other types of cancer.
• Meeting with Mr. Xidakis Costas, Ph.D. and Head of Sales at EnzyQuest P.C. | 29.06.2022 •
EnzyQuest is a Heraklion Crete-based biotech start-up focused on developing and commercializing new enzyme products that allow for more efficient manufacturing and analytical processes. The EnzyQuest team carries extensive experience in enzyme discovery and manufacturing. Their enzymes find applications in research, health and food industry. On Wednesday 29.06.2022 Mr. Xidakis Costas, visited our lab and there we presented our DIAS project. He congratulated our team for our innovative technology and he was very happy that young researchers had the courage to face such a serious disease. He told us, from his experience, that the market is very familiar with molecular tools and biotech products and that the timing is right for our diagnostic tool to travel into the Enterprise world. 29
• Transfer Technology Office, AUTh | 2.09.2022 •
On Friday 2.09.2022 we contacted Mrs. Eri Toka, Responsible at the technology transfer office of the Aristotle University of Thessaloniki, to inform us about the patent filing process. In addition, we discussed the legal rights that the University should have as our diagnostic tool was developed in lab facilities of the University. She advised us to file the patent before we publish our methodology to the public in detail, i.e. before the wiki freeze. So we followed her advice and on 11.10.2022 we filed a Provisional Patent to secure the rights of the DIAS project. For more information visit: Entrepreneurship.
• BEYOND EXPO 2022 | 29.09.2022 •
Beyond is the first international stage for Industry in South Eastern Europe, the Mediterranean and the MENA region. The exhibition is designed to address today's needs and become the melting pot of the world's brightest minds, talents, and products. From top speakers and exhibitions to open innovation, live experiences and product launches. For the first time in Greece, Beyond offered a dedicated stage for all those who thrive in the business of consumer technologies, a hybrid “exhibition meets summit” platform. It aimed to transform Thessaloniki into a technology and innovation hub for the broader region and contribute constructively into Greece's digital transformation. There, our team had a stand in the Paviliov 14 in order to present our diagnostic tool to entrepreneurs and representatives of medical and pharmaceutical companies.
There we had the opportunity to get in touch with potential stakeholders for our diagnostic tool and get their feedback. Most congratulated us for our diagnostic methodology we proposed and told us that if we follow the proper procedures accurately, the DIAS diagnostic tool will soon reach the diagnostic centers and the public will be able to use it. We were advised to accurately determine the cost so that it is clear that this is an inexpensive diagnostic tool that can be easily produced and supported by the healthcare system. Finally, we made a Pitch deck presentation in one of the exhibition halls and many entrepreneurs told us that such a diagnostic tool will definitely have a future in the market and will approach investors.
Government
During our journey up to the final stage of iGEM Competition our team had the chance to meet members of the Greek Government in order to present our project DIAS and to receive their advice.
At the beginning of the creation of our team and in our first steps where we had decided that we wanted to deal with the treatment of lung cancer, we had the honor on 26.11.2022 to meet with the President of the Hellenic Republic, Mrs. Katerina Sakellaropoulou. We showed her statistical data describing lung cancer death rates to explain to her why we chose this particular disease. Indeed, she too confirmed the seriousness of the problem and stated that she felt proud that a group of young researchers decided to provide a solution to a global problem.
Then on 10.09.2022, we met at the Thessaloniki International Fair with the Minister of Education, Mrs. Kerameus Niki and the Deputy Minister of Education Mr. Syrigos Aggelos. At the beginning, we presented them with the DIAS project and explained how the diagnostic test will be performed. They were excited by the fact that simple routine blood tests will allow a person to know if they have lung cancer. They explained to us that they consider the early diagnosis of such diseases very important and wished us by developing this tool to succeed in reducing the mortality due to lung cancer. They congratulated us for our idea and they promised that they will support our future steps.
Finally, on 17.09.2022 we met with our PI, Mr. Tsipras Alexis, Member of Parliament. We described in detail our diagnostic methodology and he was excited by our innovative idea. He emphasized that cancer is a disease that afflicts all people in the world and that he notices that as the years' pass, the new cases increase. He also told us that he is very glad that a student group decided to tackle this big problem. He congratulated us on our perfect organization of the detailed laboratory design and told us that he hopes in a few years to be one of the first to do the DIAS test.