Resolving Social Issues through Our Business Nichirei Biosciences
In the past, patients diagnosed with the same type of cancer were all given the same treatment. In recent years, though, advancements in biomarker research have led to the discovery of gene mutations involved in the initiation and progression of cancer, and therapies targeting those genes and proteins created from them (molecular targeted therapies) have been developed. Compared to conventional anti-cancer drugs that also act on normal cells, molecular targeted therapies offer advantages including minimizing side effects. However, since these treatments are unlikely to be effective in patients who do not have the target gene or protein, in vitro diagnostics (companion diagnostics) have been developed to accurately diagnose whether the patient is a suitable candidate for treatment with the molecular targeted therapy before treatment begins.
In cancer treatment, pathological diagnosis is performed on tumor tissue collected from the patient. A thin specimen, sliced from the tumor tissue, is examined by a pathologist to obtain critical information about the cancer. This information is then used to determine a treatment plan. An important testing technique widely used in pathological diagnosis is immunohistochemical staining, which enables the detection and visualization of specific substances, such as proteins, in the specimen. A specialized reagent is required to perform immunohistochemical staining, and Nichirei Biosciences is one of the few companies with the technology to develop and manufacture that reagent. Based on this technology, the company develops, manufactures and supplies companion diagnostics. In 2019, Nichirei Biosciences acquired and made a subsidiary of U.S. company Pathcom Systems Corporation, which develops and manufactures equipment for automating immunohistochemical staining, to further strengthen its capabilities in companion diagnostic development.
Nichirei Biosciences developed a proprietary amino acid polymer reagent called Universal Immuno-enzyme Polymer. The use of this reagent enables the detection of proteins or other biomolecules (antigens) through antibodies that bind to them specifically. Applying this reagent to immunohistochemical staining, a technique used in pathological diagnosis, makes it possible to detect and visualize antigens in the pathological tissue sample. This reagent has been commercialized for immunohistochemical staining, and also applied to a companion diagnostic product.
![[Principle of Companion Diagnostics] Application of Proprietary Technology to Immunohistochemical Staining](/img/en/13_materiality/1318-02.png)
Even in the same type of cancer, there are patients who have different types of gene mutations, but until recently, a one-size-fits-all treatment regimen was implemented, using drugs with mechanisms that suppress the active proliferation of cancer cells.
The emergence of molecular targeted therapies has enabled patients to select a therapy according to each one’s gene mutations, and therapies with relatively mild side effects are now possible. Companion diagnostics have become an essential test for accurately choosing patients who can be expected to benefit from a specific molecular targeted therapy, as well as patients who are unlikely to benefit.
The market for molecular targeted therapies continues to expand, and development of molecular targeted therapies and other treatments targeting specific gene mutations and proteins is expected to increase. Possessing unique technologies applicable to development of companion diagnostics, Nichirei Biosciences will contribute further to the advancement of personalized medicine in cooperation with academia and partners who develop therapies.
