The first step in the development of an allergy is sensitization to the substance. Sensitization occurs when substances the body considers foreign come in contact with our immune system for the first time. Allergies are caused by proteins or substances such as chemicals that are small enough to be absorbed via the skin, respiratory tract or other means. If these are considered foreign by the dendritic cells and also give rise to immunological “danger signals” and co-stimulation, sensitization occurs, which can lead to an allergy such as contact eczema or allergic asthma if the individual is exposed to the substance again. GARD® is designed to assess a substance’s capacity to cause sensitization.
Dendritic cells are a type of white blood cell that specializes in identifying foreign substances. When these cells recognize substances that can be harmful to the body, they activate and regulate the other parts of the immune response to handle the foreign substance. The immune system’s main task is to protect the body from attacks by various types of microorganisms, such as bacteria and viruses, but sometimes it reacts to other substances, which can lead to an allergic reaction. When dendritic cells recognize a substance as foreign, they are activated and change their function and appearance. These changes start with expression regulation of various genes; this can be measured using various techniques, and this is what serves as the foundation for the GARD test’s capability to differentiate between allergenic chemicals and non-allergenic chemicals.
Genomics is defined as the study of an organism’s entire genetic material (the genome) and how it functions. Increased knowledge about our genetic material enables us to measure how genes are regulated and expressed to predict biological functions and obtain an overall view of what is happening in the body during sensitization and similar processes. In total, there are approximately 25,000 genes in our genetic material that each have different tasks and express or turn off as needed. Genomic tests have the capability to examine all of these genes and how they are regulated in a cell, tissue or organ in response to various circumstances. Examining all genes gives us a detailed view of, for instance, what happens in a dendritic cell when it is exposed to an allergenic substance. Understanding and analyzing all the information usually requires modern data processing. GARD is based on a gene structure developed using genomics, statistical analysis and machine learning.
Modern machine learning allows computers to recognize patterns in large quantities of data. The term machine learning refers to computers’ ability to learn from data without having to be programmed for the specific task. The technology is used for purposes such as image analysis to identify tumours and, in SenzaGen’s case, to recognize gene expression in dendritic cells exposed to allergenic substances. By training the Company’s model on the gene signatures developed, SenzaGen has succeeded in generating prediction models that accurately classify a substance as potentially allergenic or non-allergenic.