Skip to main content
Premium Trial:

Request an Annual Quote

AITbiotech Gets ISO Certification for Genomic, MDx Labs

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."

The Scan

Missed Early Cases

A retrospective analysis of blood samples suggests early SARS-CoV-2 infections may have been missed in the US, the New York Times reports.

Limited Journal Editor Diversity

A survey finds low diversity among scientific and medical journal editors, according to The Scientist.

How Much of a Threat?

Science writes that need for a provision aimed at shoring up genomic data security within a new US bill is being questioned.

PNAS Papers on Historic Helicobacter Spread, Brain Development, C. difficile RNAs

In PNAS this week: Helicobacter genetic diversity gives insight into human migrations, gene expression patterns of brain development, and more.