The research facility of Craif Inc. (Location: Bunkyo-ku, Tokyo, CEO: Ryuichi Onose, hereinafter referred to as “Craif”), Craif Chubu Test Center, has completed full registration as a Clinical Laboratory.
Details of the registration will be as follows.
[Register No.] No. 35, Gene-related and chromosome testing (Somatic genetic testing)
■ Background of this Registration
As defined in Act on Clinical Laboratory Technicians, a registered Clinical Laboratory is a facility that examines specimens collected for diagnosis and medical checkups. For registration as a Clinical Laboratory, the facility needs to be examined by a public health center if its buildings and equipment, management organization, and the methods of ensuring the accuracy of testing conform to the standards specified by Order of the Ministry of Health, Labour and Welfare, and needs to obtain registration by the prefectural governor with jurisdiction over the location of the clinical laboratory. Since examinations can be easily done at a laboratory which is established without any inspection, faulty testing services with poor monitoring systems and insufficient quality control can be released in Japan. In order to ensure quality improvement and control of the testing services industry as a whole, including “miSignal™” series, “Craif Chubu Test Center” was established as a registered Clinical Laboratory.
■ Future Challenges
We have established a resolute testing system in order to deliver a highly accurate and quality assured service for users of “miSignal™,” a urinalysis to detect early stage cancers. Along with the registration as a Clinical Laboratory, we will continue to make efforts to establish an even more substantial testing system.
■ Information about “miSignal™”
miSignal™ is a PCR test that detects urinary microRNA (miRNA), which plays an important role in the onset, progression, and metastasis of cancer. Using our distinctive proprietary technology, “miSignal™” efficiently captures urinary miRNAs and detects early stage cancer with high accuracy. The greatest feature of this service is that it is “painless.” By simply providing urine to a medical institution, patients can easily check the risk of cancer without any burden. The number of cancer types that “miSignal™” covers will be increased as research and development progresses. For further details, please visit our website (http://misignal.jp/).