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Twist Bioscience Supplies Centers for Disease Control and Prevention with Custom SARS-CoV-2 Synthetic RNA Controls

January 07, 2021 08:00 AM Eastern Standard Time – 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 it will supply the U.S. Centers for Disease Control and Prevention (CDC) with a customized version of Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. The CDC SARS-CoV-2 (Flu SC2) Multiplex Assay tests for influenza A, B and SARS-CoV-2 simultaneously.

Positive controls provide quality control measures for the development, verification, and ongoing validation of both next-generation sequencing (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays. In addition to using the assay at its primary site, CDC intends to distribute this multiplex assay to additional public health laboratories for testing across the United States.

“We have partnered with the CDC over the last several months to optimize these controls to be stable at room temperature for ease of shipping and storage,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “Integrating our SARS-CoV-2 control into the Flu SC2 Multiplex Assay supports the accurate detection of SARS-CoV-2 in specimens from patients exhibiting symptoms that could result from either COVID-19 or the flu. We remain committed to using our robust synthesis platform to work with industry and government agencies to improve health globally and expect to make these optimized controls widely available to customers later this month.”

In March 2020, Twist launched 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 to test for SARS-CoV-2. These controls continue to be included in many different assays worldwide and can be used to determine the limit of detection, monitor day-to-day test variations, and are included on the U.S. Food and Drug Administration (FDA) website as reference materials for SARS-CoV-2. In June, additional SARS-CoV-2 controls were released to cover the evolution of the virus, and in December, Twist announced plans to develop controls for a newly identified strain known as the UK strain or B1.1.7 lineage, variant under investigation VUI-202012/01, which it expects to release in mid-January 2021.

Twist provides custom controls and offers a suite of research tools including next-generation sequencing (NGS) products for SARS-CoV-2 as well as a broad respiratory panel and the most comprehensive viral research panel. For more information on the Twist products to combat COVID-19, please visit: https://www.twistbioscience.com/coronavirus-research-tools. Customers purchasing synthetic controls are subject to Twist’s leading biosecurity screening protocols and applicable laws and regulations.

About Twist Bioscience Corporation

Twist Bioscience is a leading and rapidly growing synthetic biology and genomics 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 the CDC and its customers and the wide availability of the optimized controls in January 2021, 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 Form 10-K filed with the Securities and Exchange Commission on November 27, 2020 and subsequent filings with the SEC. 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.

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