OncoDNA announces ISO 13485:2016 certification

Gosselies, October 17, 2019

OncoDNA announces ISO 13485:2016 certification

OncoDNA, the cancer theranostic company announced today that he has achieved the ISO13485:2016 certification. This ISO norm specifies the requirements for quality management systems (QMS) in the medical device industry. Being certified indicates that the company’s quality management system meets the most recent regulatory and quality requirements in the field of medical devices.

This ISO 13485:2016 certification complements the ISO27001:2013 certificate received recently. The latter describes the requirements for the management of information security and helps the company to meet GDPR (General Data Protection Regulation) compliance.

 

Jean-Pol Detiffe, Co-founder and CEO of OncoDNA said: “At OncoDNA, we are very proud of this certification, it is an added value for our company and our customers. It demonstrates the commitment of our teams to meet quality, regulatory and customer expectations. It is also an important step for OncoKDM, our web-based Next Generation Sequencing data interpretation software, to remain a state-of-the-art product” .

 

 

ABOUT ONCOKDM

From variant detection to clear therapeutic decisions, OncoKDM is the most innovative way to interpret cancer data.

 

OncoKDM is a web-based platform that turns your NGS data into actionable clinical information that you can access via an interactive report. This report includes the NGS quality control results, patient clinical data, variant annotation, related treatments and clinical trials options. Moreover, OncoKDM can integrate NGS results with IHC, MSI and TMB data to provide you with an up to date and accurate clinical interpretation.

 

The comprehensive and interactive report includes quality control data, patient clinical data, in-depth NGS variants annotation, treatments and clinical trials option.

 

OncoKDM works from raw NGS (BAM or FASTQ) data but also from your VCF files and do not requires any software installation.

 

Discover on: www.oncokdm.com

 

Download the PDF

 

About OncoDNA

OncoDNA is a private, oncology-focused healthcare technology company that combines advanced, comprehensive testing of all clinically relevant cancer biomarkers (DNA, RNA and protein profiles) from both solid and liquid biopsies, using a proprietary cancer treatment knowledge database called OncoKDO™. The database ‘learns’ continuously from cutting-edge, validated scientific and medical advances. This one-stop-shop analysis and interpretation service gives oncologists actionable results to enable the selection of treatments tailored to an individual patient’s cancer profile. Worldwide, we provide laboratories that have NGS facilities and that would like to reach the same level of expertise with state-of-the-art interpretation software to improve their oncology-oriented routine analyses. The software OncoKDM is a web-based tool that processes raw oncology data from NGS and uses them to give clinical insight into treatment options or clinical trial participation. OncoDNA also works in collaboration with the biopharma industry to develop and deliver the treatments of tomorrow, by assisting with the design, enrolment in and assessment of clinical trials as well as increasing access to approved precision medicines. The company is based in Gosselies, Belgium, and employs 55 staff members in four countries.

For more information please visit www.oncodna.com