Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

AITbiotech Secured ISO 13485 certification for its Genomic Services and MDx Labs in Singapore

Published: Wednesday, October 24, 2012
Last Updated: Wednesday, October 24, 2012
Bookmark and Share
The 13485:2003 certification are for Design, Development and Manufacturing of IVD Medical Devices for Detection of Infectious Diseases; and Manufacturing of Oligonucleotides and Sequencing Services.

With the certification AITbiotech will be able to obtain CE certification for its multiplex real-time PCR diagnostic test including its 4-plex flu assay, 5-plex Dengue assay, and 4-plex Malaria assay. It will also be able to register its assays in most Asian countries.

AITbiotech is the first Genomic Services provider in Asia to secured 13485:2003 certification for its genomic services including Oligonucleotides Synthesis, Capillary Sequencing and Next-generation Sequencing Services. With this certification, it will be able to assure customers consistent quality for these services. Its oligonucleotides can be used by medical device manufacturers as well for their manufacturing of diagnostic assays.

Dr Masafumi Inoue from the Experimental Therapeutic Centre Singapore, who is the developer of some of the assays that AITbiotech have licensed felt that it is a milestone for a local company to achieve ISO13485:2003 certification for manufacturing of IVD medical device:

"Our team is very excited to hear about AITbiotech achieving ISO 13485 certification and its CE-marking plans for its assays. The strong relationship we have with AITbiotech in the past years has synergistically produced the high-quality diagnostic assays. I am confident that AITbiotech will reap more success by bringing more competitive made-in-Singapore assays to the world in the coming years."

According to CEO Alex Thian "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. 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. We see a grow in the diagnostic companies in Asia. With the certification AITbiotech will be able to capture this growing opportunity."

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,100+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Transgenomic, Precipio Diagnostics Merger
Merger will creates a robust diagnostic platform focused on improving accuracy of cancer diagnoses.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
Analysing 10,000 Cells Simultaneously
New techniquethat traps 10,000 cells on a single chip has potential for cancer screening for individuals.
$1M NIH Grant to Refine PCR Based Cancer Test
Researchers at Cornell University, Weill Cornell Medicine, the University of California, San Francisco, and the Infectious Diseases Institute in Kampala, Uganda, recieve a four-year, $1 million grant to hone technology for a quick, in-the-field diagnosis of Kaposi's sarcoma — a cancer frequently related to HIV infections.
Genetic Tug of War Before Cells Decide Fate
Researchers report that as developing blood cells are triggered by genetic signals firing on and off, a 'tug of war' occurs.
Linkage Biosciences Awarded NHS Contract
Comapny announces that it has been awarded a four-year contract by NHS Blood and Transplant (NHSBT) in the UK for implementation of the LinkSeq™ Real-Time PCR HLA typing product.
Understanding Tumor Evolution
Study provides insight into tumor evolution; may point to improved diagnosis and treatment.
Frankfurter Fraud: Finding Out What’s In Your Hot Dog
Scientists have developed a technique to test the meat content of Frankfurters.
How Cloud Connectivity Can Combat the Reproducibility Crisis
This infographic explains the reproducibility crisis, and how cloud connectivity can help overcome this problem.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,100+ scientific videos