As incomprehensible as this idea sounds, DNA micro array has definite medical implications bringing about DNA testing that generates statistical statements. To understand it better, it can be compared with the traditionally used methods of clinical diagnosis. The similarity is drawn by the assessment or analysis part where documented symptoms are assessed based on the knowledge and experience of a doctor. This assessment concludes to what is called diagnosis.
This traditional method of diagnosis is based on a manual pattern-recognition by identifying symptoms and their sequence that are indicative of a disease-pattern. The traditional method of diagnosis is no simple process as it involves pattern recognition on many levels. The doctor first listens to the complaints a patient has regarding health, followed by an on-spot physical examination as well as prescribed tests for a detailed inspection of organ functions. Once all the data has been collected, the doctor analyses the patterns that are similar to various diseases and ultimately identifies the specific components or unique pattern leading to a diagnosis. This diagnosis is then used to look into appropriate therapy selection.
Microarray technology can be used as a tool for pattern recognition in medicine in the field of diagnostics. The use of minuscule chips will make disease markers to be quantifiable at the molecular level without the need for a patient to give an account of his or her health, an on-spot physical examination as well as a detailed prescribed tests analysis. The idea is to supplement the diagnostic process with technology that is statistically accurate and can provide a more authentic source of pattern recognition.
Having determined the possibility of micro arrays as a viable diagnostic technology among other implications in medical research, there are a lot of challenges that researchers and scientists need to overcome along with manufacturers and other experts such as mathematicians. The challenges faced include three basic concerns. First, there are no preexisting technical standards for micro arrays in the field of diagnostics. Second, the pattern-recognition mathematics of diagnostic microarrays is a statistician’s forte; doctors are unlikely to make sense of these. Third, except for infectious disease, there are no available surrogate bio markers in the medical community.
In the efforts to make diagnostic micro arrays a reality, the challenges need to be faced by scientists, the medical community, IVD industry and regulatory institutions alike. To further articulate the trials of diagnostic micro arrays, diagnostic nucleic acid micro arrays present a major concern. Going further, on the manufacturing level, the quality management during production process as well as that of the performance poses a major challenge in diagnostic micro arrays.
Most of the challenges discussed are with regards to the testing phase. Even after overcoming the arduous technical challenges, when diagnostic micro arrays are brought into clinical practice, manufacturing concerns will bring in hurdles such as accuracy and cost-effectiveness. But the identification of these challenges is certainly a step in the right direction. After identification, working towards solutions to overcome these challenges will bring us to a point when you will be asked if you opt for a statistical diagnosis.