SOUTHERN SAN FRANCISCO, CA and NEW YORK–(BUSINESS WIRE)–Twist Bioscience Corporation (NASDAQ: TWST), a company that enables customers to succeed through its high-quality synthetic DNA offering using its silicon platform, and Biotia, Inc., a company that uses a proprietary analysis software for the diagnosis of infectious diseases, today received extended Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the novel sequencing assay generation (NGS) SARS-CoV-2 for qualitative detection, identification and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations. The test was developed in 2020, and this expanded authorization builds on the initial EUA that was received in March 2021 for the qualitative detection of the SARS-CoV-2 virus.
The hybridization capture-based SARS-CoV-2 NGS assay has the ability to analyze the entire viral RNA sequence and determine the presence or absence of the virus. With the expanded authorization, reporting of identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g., Delta, Omicron) to clinicians is now permitted, which can help them direct clinical management appropriate for the specific virus lineage, when clinically indicated.
The clearance also allows reporting of individual mutations in patient samples, information that is important to track as the virus evolves and new variants emerge. The hybridization capture-based approach used in this assay maximizes the number of genetic variants and mutations that can be identified, where other sequencing methods may miss mutations in certain regions.
New mutations in the SARS-CoV-2 virus continue to accumulate and circulate around the world, creating concerning genetic variants that may alter the transmissibility or efficacy of the vaccine, including the newer Omicron (BA.2.12. 1, BA.4 and BA.5) variants. The virus will continue to evolve and we expect this capture-based assay to serve as an important new tool for viral identification, sequencing and surveillance. With this expanded EUA, we anticipate that this data will enable, for the first time, the appropriate treatment of COVID-19.
“We developed this test in the early days of the pandemic and while useful in detecting the presence or absence of the virus, the real value lies in receiving a full sequencing report with all mutations identified which is now available as part of the expanded EUA,” said Emily M. Leproust, Ph.D., CEO and Co-Founder of Twist Bioscience. “We believe this test will continue to be essential for monitoring the evolution of the SARS-CoV-2 sequence and is another example of our commitment to providing tools to fight the pandemic, even when it becomes endemic.
The assay utilizes Twist Bioscience’s unique ability to rapidly develop virus-specific panels through DNA synthesis and Biotia’s comprehensive data analysis software and reporting capabilities. The SARS-CoV-2 NGS test has been validated on a NextSeq® 550 Sequencing System. Because the test analyzes complete sequence data, the test reduces the likelihood of a false negative result. In contrast, the majority of SARS-CoV-2 tests based on the polymerase chain reaction (PCR) identify only limited genetic markers of the virus.
In a separate report made available to clinicians for professional interpretation, previously for research purposes only but now permitted under the expanded EUA, the full sequence of the virus is identified, and mutations and variant differentiation are reported. . The expanded EUA comes at an important time in the pandemic, as we see evidence of the failure of specific monoclonal antibody therapies against Omicron variants. Variant identification, when used in conjunction with patient history and other diagnostic findings, can now help select appropriate treatments. A article published in Microbiology Spectrum details the results of the NGS SARS-CoV-2 test with the COVID-DX solution to detect the virus and its genetic variants.
“Researchers tracked SARS-CoV-2 variants and mutations, using this analysis software, since the beginning of the pandemic. This expanded FDA clearance marks an important step forward in improving care for COVID-19 patients,” commented Niamh O’Hara, Ph.D., CEO and co-founder of Biotia. “Outside of COVID, this signals a shift in the field of infectious diseases for the future, bringing cutting-edge new genomic technology into the clinic.
About the test and the interface
The SARS-CoV-2 NGS test is a in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 nucleic acid, identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages and specific genomic mutations of the SARS-CoV-2 from the nasopharynx (NP), oropharyngeal (OP), anterior nasal and middle turbinate nasal swabs, nasopharyngeal washes/aspirates, nasal washes/aspirates as well as from bronchoalveolar lavage (BAL) specimens from individuals suspected of having COVID-19 by their healthcare provider. The SARS-CoV-2 NGS test, which includes the Twist Bioscience test SARS-CoV-2 Synthetic RNA Controlsas well as the Biotia COVID-DX software which generates a clinical report, covers the entire virus genome and identifies specific mutations and SARS-CoV-2 PANGO lineages in samples.
The complementary Biotia COVID-DX software provides a clinically oriented report including the presence or absence of the SARS-CoV-2 virus, genomic mutations and PANGO lines. FASTQ (sequencing output) files can be generated in certified clinical laboratories and submitted to Biotia COVID-DX (v1), a cloud-based software, to generate clinical reports. Access to Biotia COVID-DX software is provided through a unique order number emailed to a clinician or researcher that includes credits for each kit purchased.
SARS-CoV-2 NGS test and Biotia COVID-DX software are limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity testing. The SARS-CoV-2 NGS test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the use of the Illumina NextSeq 500/550/550Dx Sequencing System, NGS workflows, and in vitro diagnostic procedures. The SARS-CoV-2 NGS Test and Clinical Reports have not been cleared by the FDA and are only intended for use by specified personnel under the FDA EUA. Twist and Biotia also offer a Research Use Only (RUO) version of the SARS-CoV-2 NGS test, for non-clinical laboratories. For more information, click here.
Biotia is a New York, NY-based health technology company that leverages sequencing-based technology and proprietary AI-powered software to quickly and accurately identify microorganisms and antimicrobial resistance. Their mission is to fight infectious diseases by deploying the world’s first microbe reference library. Biotia, a spin-off from Cornell Tech’s Jacobs Technion-Cornell Institute, has a New York State CLIA laboratory for COVID-19 testing affiliated with SUNY Downstate Health Sciences University.
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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 proprietary technology that pioneers a new method of making synthetic DNA by “writing” DNA onto a silicon chip. Twist leverages its unique technology to manufacture a wide range of synthetic DNA products, including synthetic genes, tools for the preparation of next-generation sequencing (NGS), and antibody libraries for discovery and drug development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologic drug discovery. Twist manufactures products for 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 fact contained herein, including but not limited to the ability of the SARS-CoV-2 NGS test to successfully provide actionable information that can then be used to inform the public health and clinical decisions, reduce the likelihood of a false positive or false negative result, enable a better understanding of the mutations, genetic variability and evolution of SARS-CoV-2 during its transmission and to advance research and control of COVID-19, are forward-looking statements reflecting management’s current beliefs and expectations made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known risks and unknowns, uncertainties and other important factors that may cause results, performance Twist Bioscience’s actual achievements or achievements are materially different from any future results, performance or achievements expressed or implied by the forward-looking statements g. These 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; the risks and uncertainties of rapidly changing technologies and intense competition in synthetic biology could render the products that Twist Bioscience develops obsolete or uncompetitive; uncertainties about the retention of a significant customer; the risk 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 more detailed 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 generally, see Twist Bioscience’s risk factors stated in Twist Bioscience’s quarterly report. Form 10-Q filed with the Securities and Exchange Commission on May 6, 2022 and subsequent filings with the SEC. All 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 statements, whether as a result of new information, future events or otherwise.