Genetic Analysis for Drug Development

RG Quality Assurance Standard

Genetic analysis and experiments have been carried out at RIKEN GENESIS in compliance with our RG Quality Assurance Standard, which is based on the GLP (Good Laboratory Practice) ordinance for pharmaceuticals.

College of American Pathologists (CAP)

RIKEN GENESIS has accreditation for its genetic analysis service from the College of American Pathologists (CAP) since April 2010.

RIKEN GENESIS is the first CAP accredited facility in Japan as an independent genetic analysis laboratory. CAP accreditation, which is granted through examination and inspection of clinical test laboratories, confers recognition of the technical standards of the systems.

CAP accreditation is a testament to the world-class quality assurance and reliability of technology. Results of genetic analysis carried out by RIKEN GENESIS will be accepted by the US Food and Drug Administration (FDA).

CLIA Certificate

Riken Genesis has Clinical Laboratory Improvement Amendments (CLIA) certificate for the genetic analysis.
CLIA is a United States law that has been made for the quality standards for all clinical laboratory when they test human specimens for diagnosis, prevention or treatment. CLIA certificate is issued by the Centers for Medicaid Services (CMS) which takes a role on the public health care system in the Department of Health and Human Services of the United States. The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) also support the CLIA program.

Illumina CSPro

Received Illumina's CSPro(Certified Service Provider) since August 2008.

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