Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

ACD Receives ISO Certification

Published: Tuesday, August 12, 2014
Last Updated: Tuesday, August 12, 2014
Bookmark and Share
ACD’s ISO 13485:2003 certification covers the design, development, production, and commercialization of ACD’s proprietary RNAscope® product lines.

Advanced Cell Diagnostics, Inc. (ACD) has been granted ISO 13485:2003 certification, an international quality standard for medical devices, paving a path for ACD to launch its CE marked diagnostic tests in Europe.

The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. 

Addressing a long-standing technological gap in the analysis of RNA, RNAscope has seen rapid adoption by both academic and industrial researchers since the beginning of its full commercialization in 2011. There is strong interest in moving RNAscope-based biomarker assays from research to the clinic.

"ACD's vision is to make RNAscope the PCR equivalent for in situ nucleic acid detection and drive adoption of this technology in diagnostic tests," states Dr. Yuling Luo, President and CEO of ACD. "This ISO certification is the first step in our quality systems road map, which is designed to ensure that we supply products of the highest quality to our customers and provide a seamless path for our partners to translate scientific advances to patient benefits."

ACD's RNAscope technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying biomarkers with single‐molecule sensitivity. Unlike “grind‐and‐bind” assays such as RT‐PCR requiring RNA extraction from tissues, RNAscope detects and localizes single RNA molecules in individual cells in intact tissues, enabling simultaneous molecular and histopathological analysis.

Unlike immunohistochemistry (IHC) which is often limited by lack of quality antibodies and inapplicable to the large emerging class of non‐coding RNAs, RNAscope assays can be developed and validated in two weeks for virtually any gene in any genome regardless of coding potential. RNAscope assays can be performed manually or fully automated using standard automated slide staining instruments for IHC and ISH, allowing seamless integration of RNAscope into current clinical laboratory workflows.


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 5,000+ 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.

Related Content

Advanced Cell Diagnostics Launches New Website and Online Store
Better serving the scientific community, the new site is equipped with a fresh design and interactivity, and features e-commerce capabilities.
Tuesday, October 13, 2015
ACD Completes $22 Million Series C Equity Financing
Proceeds will accelerate commercialization and launch of new technology platforms.
Friday, June 19, 2015
Advanced Cell Diagnostics Appoints Tom Olenic as Chief Commercial Officer
Advanced Cell Diagnostics, Inc. (ACD) has announced the appointment of Tom Olenic to its executive leadership team as Chief Commercial Officer.
Tuesday, December 02, 2014
MicroMatrices, Advanced Cell Diagnostics Partnership
MicroMatrices becomes preferred partner for preclinical use of ACD’s RNA ISH.
Monday, November 10, 2014
ACD Awarded $1.4 Million NCI Grant
Two-year grant to develop ultrasensitive diagnostic test for B-Cell lymphoma.
Wednesday, October 08, 2014
ACD Establishes Subsidiary to Serve the European Market
Subsidiary will enable easy ordering, fast delivery and enhanced support for EU customers
Monday, September 15, 2014
Scientific News
Over Two-Thirds of Cervical Cancer Deaths Prevented
Cervical screening prevents 70% of cervical cancer deaths and if all eligible women regularly attended screening this would rise to 83%.
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Mechanisms of Parkinson’s Pathology
Defects that lead to cells’ failure to decommission faulty mitochondria cause nerve cells to die, triggering the symptoms of Parkinson’s disease.
Case for Liquid Biopsies Builds in Advanced Lung Cancer
Study addresses unmet need for better, non-invasive tests called out in recent "Moonshot" blue ribbon panel report
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Genetic Diversity of Enzymes Alters Metabolic Individuality
ToMMo scientists have shown that genetic polymorphisms, structural location of mutation and effect for phenotype correlate with each other.
IMM Uses Nanowizard® to Evaluate Cardiovascular Disease Risk
JPK Instruments reports on the use of their NanoWizard® AFM system at the Instituto de Medicina Molecular at the University of Lisbon.
$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.
Zika Reference Strain Sequenced
An international research team has sequenced a strain of Zika for use as a WHO reference strain.
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
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!