Twist Bioscience Synthetic SARS-CoV-2 RNA Controls Added to FDA Website as Reference Materials

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that its synthetic SARS-CoV-2 RNA Controls to provide quality control for the development, verification, and ongoing validation for diagnostic tests are now included on the U.S. Food and Drug Administration (FDA) website as reference materials for SARS-CoV-2.

“We are working around the clock to provide critical tools for researchers and test developers worldwide to fight this global pandemic,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “We are thrilled to engage with the FDA to inform the community about the availability of these reference materials and work to provide products that leverage our core strengths in synthesis of nucleic acids. When each group brings their A game, together, we can make incredible progress in identifying, treating and eventually defeating COVID-19.”

Twist offers two fully-synthetic SARS-CoV-2 RNA distinct reference sequences as positive controls for the development of both next-generation sequencing (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays. In addition, these controls can be used to determine the limit of detection and monitor of day-to-day test variations.

• Twist Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)
• Twist Synthetic SARS-CoV-2 RNA Control 2 (MN908947.3)

The Twist synthetic controls are designed based on two specific SARS-CoV-2 variants and cover the full viral genome and are sequence-verified. For customers interested in alternative variants of SARS-CoV-2, Twist is able to create synthetic RNA controls within two weeks. For more information on the Twist Synthetic SARS-CoV-2 RNA controls, please visit: https://www.twistbioscience.com/coronavirus-research-tools. A webinar describing the positive controls and the general needs of the research community can be found here.

Customers purchasing synthetic controls are subject to Twist’s leading biosecurity screening protocols and applicable laws and regulations.

In addition to working with customers to provide synthetic controls, Twist offers Research-Use Only (RUO) target enrichment next-generation sequencing (NGS) panels for viral detection and characterization of samples from patients testing positive for SARS-CoV-2, which can be used for environmental monitoring and surveillance testing, while also providing insight into full sequence information to track viral evolution and strain origin.

Twist is also synthesizing Clonal Genes and Gene Fragments that enable quick development of subunit vaccines from one or more antigen-presenting viral gene or peptide sequence, bypassing the need for scientists to handle live and potentially dangerous pathogens and eliminating the time needed to clone DNA fragments. And, Twist offers Research-Use Only (RUO) target enrichment NGS panels for viral detection and characterization of samples. The company remains committed to continued innovation and delivery of products to meet the evolving needs of the research community.

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.

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Legal Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including without limitation Twist’s ability to deliver synthetic controls for SARS-CoV-2 to its customers and its ability to provide such synthetic controls within two weeks, 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. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 10, 2020. 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.