Safe Project Design
We discussed the safety issues of our technology throughout the whole duration of the project since we were aware of working with modified S. cerevisiae with the vision to use them in a clinical setting. S. cerevisiae belongs to the Risk Group 1, which describes the organism as not causing a disease in healthy humans. The fact that our end consumers are cancer patients who are more often immunocompromised than not could raise a significant concern. However, the design of our technology devotes it to be used by trained laboratory clinicians who receive the patients’ blood, perform the test themselves, and deliver only the results to the individual being screened.
The opinions on our technology have been very positive and encouraging. The lay person is usually very curious and thrilled once he or she grasps the concept behind our technology. A positive opinion can be seen even more clearly from the interview with Dr. Pitule and Dr. Ostasov from the Laboratory of Tumor Biology. Discussions with professionals and experts in the tumor diagnosis field indicate our product to be cheaper and easier to operate than most of the current diagnostic approaches. Also, it presents a solid competition in terms of its sensitivity and specificity compared to the current diagnostic tests. Finally, it brings a new dimension to the field providing the ability to test for several markers at once.
Discard of the used test would not be different from discarding GMO or biological material in a laboratory.
Safe Lab Work
With most of our team having extensive wet laboratory experience, it was quite effortless to follow standard lab safety practices. Furthermore, our laboratory is monitored by the Ministry of the Environment of the Czech Republic and complies with all of its regulations for a GMO laboratory. This was also evidenced by the recent visit of an inspection team from the Ministry, which was carried out without any complications.