RIKEN GENESIS Co., Ltd. (headquarters: Taito-ku, Tokyo, hereinafter "RIKEN GENESIS") and Repertoire Genesis, Inc. (hereinafter "our company") announce a recent collaboration agreement to expand the use of TCR/BCR repertoire analysis (Note 1) service with world quality standards.

RIKEN GENESIS is a company that provides numerous genetic analysis services and products utilizing state-of-the-art genetic analysis technology, and possesses a wealth of technology, experience and know-how in personalized medicine. RIKEN GENESIS will collaborate with our company to construct a provision system of TCR/BCR repertoire analysis services, at international quality standards. Genetic analysis testing by RIKEN GENESIS will be conducted to comply with RG-GLP (Note 2), which is implementation standards based on good laboratory practice ordinances for pharmaceuticals. These standards were introduced and have been in use since June 2009. Through this RG-GLP, RIKEN GENESIS has a proven track record of establishing highly reliable systems for pharmaceutical investigations and clinical trials conducted by pharmaceutical companies and clinical research institutions. RIKEN GENESIS acquired CAP (Note 3) certification in May 2010, and was registered as Japan's first CLIA (Note 4) lab in May 2015. This CLIA lab registration proves the exceptional reliability and world quality standards of RIKEN GENESIS' state-of-the-art genetic analysis.

Our company and RIKEN GENESIS will collaborate to further optimize TCR/BCR repertoire analysis and improve its quality, and also will strive to provide optimal medical care to each individual patient by committing to research development and business expansion.

Note 1. The TCR/BCR repertoire analysis is a method where DNA sequences and abundance ratio of T cell receptors (TCR) and B cell receptors (BCR), are comprehensively and quantitatively analyzed.
Note 2. RG-GLP: RIKEN GENESIS - Good Laboratory Practice. Genetic analysis testing at RIKEN GENESIS is carried out in accordance with "Ordinance on implementation standards for nonclinical laboratory studies on safety of drugs (Drug GLP Ordinance)". (Ministry of Health, Labour and Welfare Ordinance No. 21, final revised, Ministry of Health, Labour and Welfare Ordinance No. 87, July 30, 2014).
Note 3. CAP: College of American Pathologists. CAP is the world's largest medical organization comprised of pathologists and laboratory researchers. The association currently evaluates international clinical examination programs of over 23,000 clinical laboratories in 95 countries through CAP surveys, and conducts the Laboratory Accreditation Program (LAP) in which over 7,000 clinical laboratories participate.
Note 4. CLIA: Clinical Laboratory Improvement Amendments. CLIA are United States regulatory standards enforced since 1967. Their purpose is to establish minimum standards for all clinical laboratories to adhere to, with periodic inspections and blind testing carried out as a means of maintaining quality. At present, CLIA have become the de facto standards for clinical laboratories in the United States.