Vela Genomics Receives ISO Certification for Quality Management Systems
By Vela Genomics - Accurate Clinical Interpretation and Reporting: Tailoring Care Through Genomics
Singapore (November 10, 2017) – Vela Genomics, a subsidiary of Vela Diagnostics, announced today that it has received ISO 13485:2016 - Quality Management Systems Certification, from the BSI group. Vela Genomics certification has been issued in the scope of design and provision of clinical genomic service including analysis and interpretation of genes and biomarker for clinical diagnosis. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This certification is an official recognition of Vela Genomics' robust quality management systems from design and verification to validation for it's flagship product TheraKey™.
TheraKey™ is a clinical interpretation Reporting Service which provides clinicians with a complete Patient-to-Treatments matching solution in order to accelerate the adoption of Next-Generation Sequencing (NGS) in routine clinical diagnostics. At the heart of the Service is Clinical Interpretation Reporting Software, which is also called TheraKey™. The software is powered by a proprietary Natural Language Processing (NLP) engine and analytics pipeline that extracts, filters and agglomerate key entities such as genes, mutations, diseases, treatments and drug response from relevant public and commercial databases on a regular basis. TheraKey™ generates an easy to read clinical report that has a clear and concise summary of relevant therapies and clinical trials. While providing a traceable and reproducible solution, Vela Genomics is consistently maintaining high standards of data security and ensures adherence to risk mitigation best practices.
One of the biggest challenges clinicians face when using NGS for routine clinical diagnosis is the interpretation of genomics data and subsequent application. Generating an actionable clinical report from genomic data, that could be potentially huge, is typically a time-consuming and inconsistent manual process that entails cross referencing information across multiple data sources. With TheraKey™, clinicians need to submit only the Variant Calling File (VCF) and disease diagnosis of their patients to receive corresponding actionable clinical reports within 1 to 3 working days.
The TheraKey™report not only indicates the disease, gene or variant specific drugs approved by the Food and Drugs Administration (FDA), but also provides other drugs approved by regulatory bodies, as well as investigational drugs that could be effective for the patient, therefore providing clinicians with the broadest treatment options available. Up-to-date clinical trials that have the most relevance to the genomic biomarkers, disease diagnosis, eligibility and location proximity of the patient are included in the report as well.
Customers have an option to choose automated or curated reports. The automated pipeline can generate report using curated knowledgebase (Therabase) without any review by curators. Curated reports are verified by highly qualified Curators adhering to the National Comprehensive Cancer Network (NCCN) Guidelines®, highlighting contraindicated therapies if any, before they are made available to clinicians. This guarantees a timely, consistent and accurate clinical report that clinicians can use to provide tailored treatments to their patients.
Vela Genomics currently provides Clinical Interpretation and Reporting for oncology, with the intention to expand to infectious diseases and other genetic diseases. A database comprising of genomic data from samples donated by patients from collaborators, coupled with associated clinical and drug response data will be developed to provide new insights into the biology of diseases and aid in the identification of novel drug targets. TheraKey™service can be ordered at www.velagenomics.com. For enquires, please email email@example.com.
About Vela Genomics
Vela Genomics is a subsidiary of Vela Diagnostics, a pioneer in offering both PCR and NGS on an integrated platform with Global network connected to direct operations and distributors across North America, Europe and Asia Pacific. Vela Genomics is committed to delivering medical, technical and economical benefits to customers around the world. With our advanced bioinformatics and clinical curation expertise, we aim to empower healthcare by delivering the most accurate and sophisticated clinical interpretation and solutions to help target treatments.