Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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 3,900+ scientific posters on ePosters
  • More Than 5,300+ 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 TechnologyNetworks.com 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
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
BGI Sequences Gingko Tree, Revealing Large, Highly Repetitive Genome
Researchers at BGI have sequenced the more than 10-gigabase ginkgo genome to find a high number of repetitive sequences as well as a number of gene clusters that appear to be involved in defense mechanisms.
Survey of New York City Soil Uncovers Medicine-Making Microbes
Microbes have long been an invaluable source of new drugs. And to find more, we may have to look no further than the ground beneath our feet.
Accelerating the Detection of Foodborne Bacterial Outbreaks
The speed of diagnosis of foodborne bacterial outbreaks could be improved by a new technique developed by researchers at the Georgia Institute of Technology.
Making Personalized Medicine a Reality
Groundbreaking technique developed at McMaster University is helping to pave the way for advances in personalized medicine.
Scientists Identify Unique Genomic Features in Testicular Cancer
The findings may shed light on factors in other cancers that influence their sensitivity to chemotherapy.
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
Scroll Up
Scroll Down
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
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!