In the present day healthcare sector, in-vitro diagnostics plays a vital role in the way a doctor administers remedies to a patient. The data gained from the tests and scans can be used to accurately predict the condition of an individual and allow for the efficient diagnosis and intervention of the consulting medic. While modern-day technology has led to innovations in the scanning systems and the time to deliver results, these are mostly for common health issues rather than infectious diseases.
One company, a joint venture by well-known Italian and Dutch-based diagnostics and life sciences companies, Adaltis S.R.L. and Gamida B.V. that is hoping to make a change in the efficient and affluent combat against infectious diseases is ADOR Diagnostics. The in-vitro diagnostics solution provider is presently running tests on its medical device—NATlab MDx— and is planning to launch the system during 2021. In its current state, the NATlab MDx System can scan genome samples for infectious diseases in a matter of minutes rather than hours or days, and in turn, this dynamic change will allow for quicker medical intervention and care.
In an interview with MedTech Outlook, Dr. Ari Tadmor, CEO at ADOR, divulges information about the in-vitro diagnostics space, the benefits of the NATlab MDx System, and the future of the company.
How does ADOR plan to create an impact in the in-vitro diagnostics arena?
The diagnostics area is divided into three parts—chemical, immunology, and molecular. A chemical test is to check for elements such as iron or any such materials. Whereas, immunology which estimates for about 30-40 percentage of diagnostics today, is everything to do with tests such as LH, FSH, tests during pregnancy and so on. The final part and the most advanced is molecular or genetic testing, and this is where ADOR Diagnostics is looking to create an impact.
At ADOR, the prime focus is on molecular testing and the intensification of the standard practice of Polymerase Chain Reaction (PCR) or real-time PCR. Another technology that is penetrating the diagnostics market is isothermal amplification, a process used to intensify the structure of DNA to pin-point diseases or external pathogens that are affecting a patient. But usually, these tests are labor-intensive because the DNA sample has to be prepared for isothermal or PCR amplification. The NATlab MDx System will not only utilize an advanced form of isothermal amplification—RCA (Rolling Circle Amplification), but we will also be the only firm to do it on a multiplex for numerous parameters.
What makes ADOR stand out from the crowd?
Our most significant differentiation is the sole focus on multiplex molecular testing and the ability to come up with panels very fast. When the time to turnover is less for the diagnostic test, it means that the dissertation of the sample is quicker in comparison to what it was earlier. For instance, if we wanted to develop a panel with ten parameters in the past, a technician would have to run isothermal amplification cycles every two hours. It meant that two or three experiments were possible per day. Today, with our technology, we can have a hundred parameters in about half an hour. Since the development of our MDx system was swift, we were able to cover a variety of mutations towards specific viruses adequately. This delivery time was crucial because it gave us a huge advantage when we initially approached the market with the solution.
While general sequencing of a sample can detect or diagnose thousands of genes or DNA portions of interest, it takes quite a long time to complete, and consequently, the entire procedure is quite expensive and complicated. Our vision is to do the same tests on a cheap disposable cartridge in less than half an hour. It is science fiction, but to have it as an instrument that can be placed in the rural villages of Africa or the most crowded place of the United States, and give extremely reliable diagnostics for thousands of potential pathogens in less than 30 minutes is unfathomable. We think that our innovation is going to revolutionize the way clinical technicians perform present-day diagnostics.
The NATlab MDx System will not only utilize an advanced form of isothermal amplification— RCA (Rolling Circle Amplification), but also be the only firm to do it on a multiplex for numerous parameters
Could you elaborate on the futuristic diagnostics platform, “NATlab” that ADOR is set to launch in the market?
The NATlab system is the first product that we are going to introduce in the market. It is a compact instrument that will analyze one cartridge at a time, and it is the size of a large shoebox. The system will have a master panel or cockpit, and it will allow users to control one reader or more with a maximum limit of up to 15 units.
Each one of these units will report the result of one sample, which will be collected on one disposable cartridge. It is an entirely closed system, which means once we have introduced a sample to the system, nothing can go in or out, or be exposed to external air. Everything is encapsulated within the NATlab system, and by the end of the diagnostic procedure, end-users receive a reading of the results and can prepare to dispose of the waste depending on the test.
Every cartridge is suitable for one test sample, such as urine, fecal matter, or blood, as long as it carries DNA that can be collected and introduced to the system. NATlab is designed to directly report the results to the central systems of a hospital or laboratory and is extremely user-friendly. A user can master the system in under an hour.
What does the future hold for ADOR over the next 12-18 months?
Our diagnostic system is still under development, we have introduced the device at a few medical centers for trials, and the results are extremely promising. ADOR is working with scientists groups from Germany, Israel and the U.S. to develop the system. The reason we scattered our development groups all over the globe is that we carefully chose specialists in every field to contribute to our research, which consists of extremely high precision fluidics, high-level molecular biology and RCA electrochemistry.
In terms of operations and market focus, our concentration is in Europe and America. Besides, we plan to introduce our NATlab system at the ECCMID 2020 event at Paris, France in April. Presently, we are building a production facility in Rome that will produce and functionalize cartridges as well as the NATlab system, and the facility is going to be active and fully operational by the end of the year. We plan to finalize our development, complete clinical studies, and launch the product very shortly.