Twist Bioscience Receives ISO 13485:2016 and 9001:2015 Certifications of its Quality Management Systems for NGS Target Enrichment Panels
Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA, today announced that its quality management systems for manufacturing its next-generation sequencing (NGS) Target Enrichment Panels received International Organization for Standardization (ISO) 9001:2015 and 13485:2016 certification1, the latter for medical device applications. Twist Bioscience offers NGS Solutions including Twist Custom Panels and Twist Human Core Exome Kits.
“Based on its ability to provide robust and clinically-actionable data, we believe NGS is already changing the landscape of identification and diagnosis of disease,” Emily M. Leproust, Ph.D., CEO and co-founder of Twist. “As part of the overall NGS workflow, our NGS target enrichment panels lower the bias and inefficiencies in downstream sequencing analysis, saving our customers time and money. In addition, our customization capability supports our customers in the development of their assays, scaling rapidly from development to full commercial scale with competitive turnaround time.
“We are extremely pleased to receive ISO 13485:2016 and 9001:2015 certification as it validates that all aspects of our quality management systems, including our production processes, were inspected thoroughly, meeting the highest quality standards for their intended use. In addition to continuing to provide exceptional customer service to our current customer base, we now have the ability to support customers in more regulated markets that require ISO certification from their key reagent suppliers.”
About ISO Certification
The International Organization for Standardization is an independent, non-governmental organization with a membership of 163 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based market relevant international standards that support innovation and provide solutions to global challenges.
About the Twist Bioscience Exome and Custom NGS Preparation Solutions
Applying its proprietary DNA synthesis technology, Twist Bioscience has developed sample preparation products for customers performing NGS experiments and analysis. The Twist Human Core Exome Kit & Twist Custom Panels are modular kits that include the tools needed for library construction, target capture and enrichment to prepare a sample for sequencing. This product suite is designed to provide exceptional performance, maximum capture efficiency and the flexibility to customize kit configuration. Twist Bioscience believes it is the only company to offer double-stranded DNA (dsDNA) probes within a comprehensive target enrichment kit used for exome and targeted sequencing. Using dsDNA as opposed to single-stranded DNA captures all specified sequences uniformly and avoids the problem of deamination (removal of an amino group). Deamination interferes with the accurate detection of gene mutations, and may hinder genetic results and clinical diagnoses, particularly in cancer and ancient samples. For more information please click here.
The Human Core Exome Complete Kit & Twist Custom Panels are indicated for Research Use Only.
About Twist Bioscience Corporation
Twist Bioscience is a leading and rapidly growing synthetic biology company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by “writing” DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Twist Bioscience’s belief regarding its ability to change the landscape of identification and diagnosis of disease and lower the bias and inefficiencies of downstream sequencing analysis. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Twist Bioscience’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties of the ability to attract new customers and retain and grow sales from existing customers; risks and uncertainties of rapidly changing technologies and extensive competition in synthetic biology could make the products Twist Bioscience is developing obsolete or non-competitive; uncertainties of the retention of a significant customer; risks of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Twist Bioscience’s patents or proprietary rights; and the risk that Twist Bioscience’s proprietary rights may be insufficient to protect its technologies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Twist Bioscience’s business in general, see Twist Bioscience’s risk factors set forth in Twist Bioscience’s Annual Report on Form 10-K for the year ended September 30, 2018 filed with the Securities and Exchange Commission on December 20, 2018. Any forward-looking statements contained in this press release speak only as of the date hereof, and Twist Bioscience specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Both ISO 13485:2016 and 9001:2015 certifications are for Twist’s San Francisco offices, located in Mission Bay.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190123005231/en/