What Changes Are Expected in Medical Care With the Spread of Diagnostic Biochips?
Currently implemented examples are introduced below:
The world's first method using a biochip to identify the presence of digestive organ cancers by blood testing developed by Kanazawa University (Kanazawa, Japan) is going to be industrialized throughout Europe. A bioventure originated from this university, Kubix (Kanazawa, Japan), a business tie-up with a German company was agreed, and a clinical performance study was started in Germany in July 2011. A screening business will start in December.
In this method, RNA information extracted from the peripheral blood of patients is analyzed using a DNA chip mounted with cancer-related genes. Shuichi Kaneko's group of Kanazawa University and Kubix advance research and development in co-operation. In a German bioventure, ZMO, a contract was signed and a clinical study was performed involving approximately 200 subjects in Germany. They will advance to screening business in each European country after confirming the performance. In laboratory testing in Japan, cancer patients and healthy subjects could be distinguished at 100 and 87% probabilities, respectively, and the cancer location, such as the stomach, large intestine and pancreas, could be identified in more than 80%.
The Hokkoku Shimbun says that several hospitals in Japan including those in the Hokuriku region are investigating its introduction into screening, and they are aiming at sales of US$1.5 million.[15]
A special team (the Ichiishi laboratory) of Tohoku University Biomedical Engineering Research Organization (Sendai, Japan), established as Japan's first medical engineering research base, performed a multicenter clinical study on RNA analysis using a biochip before and after dialysis in dialysis patients, targeting the dialysis treatment field, attracting attention as a one trillion yen-scale blood RNA diagnosis industry, in which the number of dialysis patients has recently markedly increased. Visiting professor Eiichiro Ichiishi succeeded in developing content to assume patient conditions (applied for international and domestic patents). Since valuable markers, such as genes related to 5-year survival, can be identified, the development of biochips close to practical use at clinical sites is expected.[16]
Medical expenses for the elderly have been markedly increasing in Japan. For the elderly to spend an active daily life, prevention is important, and high expectations are placed on biochip development enabling simple and reliable simultaneous diagnoses of many items in a small blood sample collected at home. Then there will be no need for transportation of most fragile patients, anxiety, repeated venipuncture collection and bruising.
When various diagnostic biochips are prepared, measured marker values of many items will be sent to a medical institution through a communication line, and an interview at home will be possible by a physician through a broadband network and high-resolution display. Detection markers may increase with advancement in the use of biochips, and data on health and disease markers of many individuals will accumulate, from which databases may be constructed, and correlations between the markers and diseases will be elucidated. Remote diagnosis of residents of isolated villages and islands with no physician may also be realized.
For personalized medicine, it is important to diagnose the hereditary background and disease condition by prior tests, and the expansion of need for these diagnoses with the spread of personalized medicine is predicted.
However, as described above, although the basic technologies of biochips for research and development and diagnosis have some commonality, specifications to be realized are markedly different, and a technological breakthrough is necessary.
To increase the processing capacity, biochip development is progressing to the preparation of an integrated device in which basic processes necessary for genomic/proteome analysis, such as DNA, RNA and protein extractions from cells, reactions including enzymatic digestion, PCR, loop-mediated isothermal amplification, electrophoresis, hybridization, detection of laser-induced fluorescence and electrochemical detection, are integrated on a few centimeter-squared microchips. As technology further progresses in the future, mobile and wearable disease diagnosis systems will be developed, and connection to a ubiquitous network may facilitate diagnoses at home. Biochips are also expected to exhibit marked power for the selection of drugs and companion diagnostics, leading to safe and effective personalized medicine.
Biochip development applying nano-/micro-technology and the diagnosis of diseases utilizing these were described above. Combining with these, a way to develop new therapeutic methods can be found by applying these technologies. For example, the specific killing of cancer cells utilizing the optical characteristics of quantum dots is considered.[1]
It is expected that the application of these technologies will facilitate not only 'super' early diagnosis of diseases and disease prevention based on the diagnosis, but also early treatment.
Expert Rev Mol Diagn. 2013;13(4):331-337. © 2013 Expert Reviews Ltd.
