NEW YORK (GenomeWeb News) – AITbiotech has received ISO 13485:2003 certification for its labs in Singapore that offer genomics services and molecular diagnostic testing.
The firm said that the certification is for design, development, and manufacturing of IVD medical devices for detection of infectious diseases and for manufacturing of oligonucleotides and sequencing services. It said that with the ISO certification it would be able to obtain CE certification for its multiplex, real-time PCR assays including tests for influenza, Dengue fever, and malaria. In addition, it would be able to register the assays in most Asian countries.
AITbiotech claims it is the first genomic services provider in Asia to obtain ISO 13485:2003 certification for its genomic services including oligonucleotide synthesis, and capillary and next-generation sequencing services. Its oligos can also be used by other medical device makers in their diagnostic tests, the firm said.
"Securing the certification is crucial to AITbiotech for its goal to be a significant MDx player in Asia as it is a necessary step for product registration in most Asian countries and it ensure our assays are of the highest quality," AITbiotech CEO Alex Thian said in a statement. "With regard to genomic services, the certification is also important as more and more such services are being used by researchers in the projects to develop diagnostic assays."