In Vitro Diagnostics
The Miraca Group develops, manufactures and sales diagnostic products globally that are used at medical field for early detection and diagnosis.
Global leader in immunoserological testing
Fujirebio is the first company in the world to successfully commercialize serological reagents for syphilis, and launched Treponema Pallidum Hemagglutination (TPHA) kit in 1966. Since the establishment in 1950, the company has supplied a wide range of products including reagents and assay instruments focusing mainly on infectious diseases and tumors to medical institutions, commercial laboratories and blood centers.
Fujirebio’s products and services have expanded through its domestic and global subsidiaries. Fujirebio Diagnostics (Pennsylvania, USA) has a competitive advantage in development and production of reagents as well as supplying of raw materials (antibodies) particularly for oncology testing. Fujirebio Europe (Belgium) specializes in development and production of reagents in the area of infectious and Alzheimer’s disease segment.
As a global leader in immunoserological testing, Fujirebio’s R&D aims to improve the reliability, accuracy, and speed as well as expand coverage of testing in Japan, the US and Europe.
LUMIPULSE, the Japanese product with an established reputation in Asia and Europe
Fujirebio launched LUMIPULSE 1200 fully automated chemiluminescent enzyme immunoassay (CLEIA) system in 1992, and continues to develop product performance to meet evolving customer needs at testing sites.
The broad line-up of reagents supports clinical diagnosis especially on infectious diseases, cancers and endocrine disorders including the metabolic syndrome. In recent years, the company expanded the product line with proprietary assays, such as HBsAg-Quant, a high sensitive HBsAg assay reagent in Japan and vitamin D reagent in Europe.
In LUMIPULSE series, we provide various processing capability models to meet market requirements. In 2015, a new model LUMIPULSE L2400 was released. This latest high-performance analyzer is capable of being integrated with a clinical chemistry analyzer, and also designed in accordance with legal restrictions of various countries and regions for future global expansion.
LUMIPULSE G1200 started its worldwide distribution in 2011 expanding its coverage in Asia and Europe including China, South Korea, Taiwan, Italy, Spain, France and Germany. There are approximately 1,500 units of LUMIPULSE in operation worldwide today assisting routine testing at medical institutions and commercial laboratories. Originated from Japan, LUMIPULSE has become a global brand of immunoassay system. For the future, we will focus on further sales expansion in Asia and Europe as well as full-scale market entry in the US.
Global development and quality assurance system
Fujirebio has established a global R&D network with its R&D teams in Japan, the US and Europe organically working together to achieve the world’s leading product quality. Its marketing team works on a global level to understand the diverse demands from various markets around the globe. Internal collaboration between the marketing and R&D teams facilitates the sharing of feedback gained from laboratories and clinical sites globally to be reflected to development activities. Fujirebio continuously works to strengthen this internal process.
To secure the highest quality of the products complying with the universal standard as the result of Fujirebio’s development and manufacturing achievement, the company fully utilizes the knowledge and expertise within the global network and constantly makes an effort to make further improvement. The products developed and manufactured in the US and Europe are approved by the US Food and Drug Administration (FDA), whose quality requirements are considered to be the strictest in the world. The company has adapted these requirements as its standards to refine daily activities to maintain the quality of the products, and obtained the international quality assurance certification of ISO 9001 and ISO 13485.
As for the environment management, Fujirebio facilities are certified with ISO 14001, and the company proactively engages in the development.