Our project is designed to function entirely on a piece of paper; no organism (besides the user) is required to make it work. Our cell-free design is made up mostly of DNA and other components necessary for protein synthesis. Some form of these components exists in every cell of every species, from E. coli to elephants. The in vitro nature of our final product would remove several potential hazards associated with a device utilizing live cells. There is no chassis organism in the final product which can escape into the environment.
The DNA used in our design is unlikely to be taken up and expressed by a naturally occurring microorganism because all DNA segments are linear and the T7 promoter driving expression is not transcribed by healthy bacteria. This greatly reduces the risks of using our recombinant DNA outside the lab. Even if the recombinant DNA used in our project were taken up by a natural microorganism, it codes for two fragments of beta galactosidase, an enzyme which is classified as a non-hazardous substance by GHS and HCS (4). The antibiotic resistance plasmids that are used for cloning should never leave a laboratory setting and would not be a part of the final product. Although these precautions alleviate some common concerns regarding the use of recombinant DNA outside the lab, it is important to remember that the project does still utilize recombinant DNA and therefore requires diligent consideration of possible unforeseen environmental effects.
The primary safety considerations of the project relate to its use as a diagnostic device. When developing such a device, false negatives and false positives are a major source of concern, and the potential damage of misdiagnosis must be carefully weighed against the benefits of diagnosing the disease correctly and quickly. Although accuracy and reliability have a large effect on a device’s safety, it is difficult to predict these parameters at such an early stage of development. Another potential danger would be the requirement of working with a small quantity of bodily fluid to operate the device. Any bodily fluid must be treated as a potential source of disease transfer between the patient and others.