BUFFALO, N.Y., Dec. 1, 2020 /PRNewswire/ — OmniSeq®, an innovator in next generation sequencing (NGS) in oncology, today announced the company has received the International Organization for Standards (ISO) 13485:2016 certification for its Quality Management Systems (QMS). ISO 13485:2016 is an international standard that sets forth the requirements for a QMS specific to the medical device industry.
This certification, provided by SGS North America, demonstrates OmniSeq’s commitment to stringent regulatory and quality management systems developed to consistently meet customer expectations and applicable regulatory requirements across the company’s clinical diagnostic testing operations, biopharmaceutical development solutions and bioinformatic analyses.
The company believes the ISO certification reaffirms its commitment to employ quality driven services in support of clinical diagnostic tumor profiling and increases its impact to advance clinical development of targeted and immune profiling therapeutics.
“This certification represents an important milestone for OmniSeq and reflects our commitment to quality in providing best-in-class clinical testing and pharmaceutical services,” said Margot Schoenborn, Chief Executive Officer of OmniSeq. “We are very proud of this certification as it reflects our rigorous and risk-based approach to design, development and commercialization of our DNA and RNA sequencing services and software systems for the identification of genomic and immune biomarkers, immune status and gene expression in oncology.”
OmniSeq’s NGS-based assays provide comprehensive genomic and immune profiling from RNA and DNA to enable oncologists to select the most appropriate therapies or clinical trials for each patient. Its suite of clinical diagnostic tests is offered exclusively by LabCorp to U.S.-based physicians through its Integrated Oncology specialty laboratory. OmniSeq’s oncology biopharma services deliver comprehensive clinical trial solutions, biomarker profiling and genomic data solutions to enrich and accelerate targeted and immune therapeutic development.
OmniSeq, an innovation of Roswell Park Comprehensive Cancer Center, is a molecular diagnostic laboratory based in Buffalo, N.Y. OmniSeq endeavors to find the right drug or the right trial for every patient by improving access to better cancer treatment options through genomic and immune profiling. OmniSeq offers three NGS-based assays: OmniSeq MSI NGS®, OmniSeq Advance®, and OmniSeq Comprehensive®. For more information about OmniSeq’s clinical products or pharmaceutical services, or to speak with an OmniSeq CARES® specialist, call +1-800-781-1259 or visit www.omniseq.com