-- Data from Research Use Only Assay and
Software Presented at Infectious Disease Week 2020 --
Twist Bioscience Corporation (NASDAQ: TWST), a company enabling
customers to succeed through its offering of high-quality synthetic
DNA using its silicon platform, and Biotia, Inc., a company that
uses proprietary analytical software for infectious disease
diagnostics, today announced the availability of an important new
research tool for the sequencing and surveillance of COVID-19.
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The companies have developed the SARS-CoV-2 Next-Generation
Sequencing (NGS) Assay, an NGS-based assay for research-use only
(RUO). The SARS-CoV-2 NGS RUO Assay is a highly sensitive nucleic
acid hybridization capture-based assay used for the detection,
characterization, and environmental monitoring of the SARS-CoV-2
virus. It utilizes Twist Bioscience’s unique ability to rapidly
develop virus-specific panels by DNA synthesis and Biotia’s
comprehensive data analysis software and reporting
capabilities.
The SARS-CoV-2 NGS Assay was validated on a NextSeq® sequencer
and identifies all SARS-CoV-2 nucleic acid sequences, to allow for
surveillance of how the genetic sequence of the virus is changing.
In contrast, a majority of SARS-CoV-2 tests based on polymerase
chain reaction (PCR) only identify limited genetic markers of the
virus. A recent study compared the
performance of three different commercially available NGS library
preparation kits confirming that hybridization capture results in
more even coverage across all sequences in a sample when compared
to PCR-based NGS assays. In addition, the SARS-CoV-2 NGS Assay
reports the full sequence of the virus, enabling improved
understanding of mutations, genetic variations and the evolution of
the virus as it is transmitted.
“While there are many available high-throughput diagnostic tests
available for COVID-19, our solution provides sequence data that
enables researchers the ability to sequence and surveil the
evolution of mutations in the virus over time and geography,” said
Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience.
“Importantly, while many labs are conducting individual sequencing
runs for each patient sample, this assay and the accompanying
software provide a way to batch about 100 patient samples together,
providing actionable information that can then be used to inform
public health particularly as we see second and third waves of
COVID escalating.”
"We are fortunate to be in a position where we can devote our
time and resources to fight this global pandemic,” commented Niamh
O’Hara, Ph.D., CEO and co-founder of Biotia. “This novel and
insightful COVID-19 solution is an important step to make NGS-based
infectious disease surveillance more widely available and to
advance COVID-19 research and control."
Biotia presented data from the assay at the Infectious Disease
Week (IDWeek) 2020 Annual Meeting that identify 124 genetic
mutations not previously described, including 26 in the
functionally important spike protein of SARS-CoV-2. The end-to-end
solution was validated on 120 clinical samples (60 positive, 60
negative), and confirmed that the SARS-CoV-2 NGS Assay powered by
the COVID-DX Software could be used to detect viral RNA in
laboratory research settings. It also provided insight into genetic
variants to track transmission, identify risk, and predict outcome
and therapeutic response. [Nagy-Szakal et
al., SARS-CoV-2 NGS Assay Powered by Biotia COVID-DX Software,
IDWeek 2020]
“This test spans both diagnostic methods and vaccine research,”
noted Christopher Mason, Ph.D., co-founder of Biotia, “We believe
this end-to-end solution brings needed tools into the fight against
COVID-19, as well as pioneering these capture methods for tracking
other pathogens in the future.”
About the Solution
The SARS-CoV-2 NGS Assay is an RUO end-to-end solution intended
for the quantitative detection of the SARS-CoV-2 virus from
nasopharyngeal (NP), oropharyngeal (OP), anterior nasal and
mid-turbinate nasal swabs as well as from nasopharyngeal
wash/aspirates, nasal aspirates and bronchoalveolar lavage (BAL)
specimens from individuals. The SARS-CoV-2 NGS Assay, which
includes Twist Bioscience’s SARS-CoV-2
synthetic RNA controls, detects all strains of SARS-CoV-2 in
samples with as few as 800 viral copies per milliliter.
The complementary Biotia COVID-DX software provides an RUO
report including the presence or absence of SARS-CoV-2 virus, the
full sequence of the virus, genetic variants and phylogenetic
analysis. FASTQ files (sequencing output) can be generated in
laboratories nationwide and submitted to Biotia COVID-DX (v1.0), a
cloud-based software to generate RUO reports. Access to the Biotia
COVID-DX software is provided through a unique order number emailed
to a researcher that includes credits for each kit purchased.
About Biotia
Biotia is a health tech company located in New York, NY that
leverages sequencing-based technology and proprietary AI-powered
software to rapidly and accurately identify microorganisms and
antimicrobial resistance. Their mission is to fight infectious
disease by deploying the leading reference library of microbes
worldwide. Biotia, a spinout company of Jacobs Technion-Cornell
Institute at Cornell Tech has a New York State CLIA lab 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 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, the ability of the SARS-CoV-2
NGS Assay to successfully advance COVID-19 research and control,
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; scientific
unknowns and new information relating to the SARS-CoV-2 virus; the
duration, extent and impact of the COVID-19 pandemic; supply chain
and other disruptions caused by the COVID-19 pandemic or otherwise;
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 August
12, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201119005413/en/
Twist Bioscience Investor Contact: Argot Partners Maeve
Conneighton 212-600-1902 maeve@argotpartners.com
Twist Bioscience Media Contact: Angela Bitting 925- 202-6211
media@twistbioscience.com
Biotia Media Contact: Steve Capoccia 617-372-1539 spc@spcoms.com
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