- Ability to sequence and surveil evolution
of virus mutations over time and geography -
- Enables batch analysis of up to 96 samples
at once; higher-plex assay development ongoing -
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 received Emergency Use Authorization (EUA) from
the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2
Next-Generation Sequencing (NGS) Assay.
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the full release here:
https://www.businesswire.com/news/home/20210324005311/en/
The SARS-CoV-2 NGS Assay is an in vitro diagnostic test, a
highly sensitive nucleic acid hybridization capture-based assay,
intended for the detection of SARS-CoV-2 RNA.
The SARS-CoV-2 NGS Assay has the ability to analyze the entire
RNA viral sequence, to determine the presence or absence of the
virus. Furthermore, in an optional research-use only (RUO) report
the software analyzes the RNA sequence to detect genetic variants
and lineages of SARS-CoV-2.1 The hybridzation capture-based
approach utilized in this assay maximizes the number of genetic
variants 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 genetic variants of concern
that may alter transmissability or vaccine efficacy, including the
most recent B.1.1.7, B.1.351, and P.1 lineages initially found in
the U.K., South Africa, and Brazil respectively. Especially given
these emerging variants, this capture-based method is an important
new tool for the identification, sequencing, and surveillance of
COVID-19.
According to the World Health Organization’s Genome Sequencing for SARS-CoV-2, published
January 8, 2021, “One advantage of using a capture-based approach
over a PCR amplicon-based approach is that capture-based approaches
can tolerate sequence differences from the probe sequences of
10–20%. This is higher than the mismatch tolerated by PCR, where
such a divergence from the primer sequences would result in a high
risk of amplicon failure. Capture-based approaches can therefore be
used to enrich successfully for relatively divergent SARS-CoV-2
sequences.”
“While there are many available high-throughput diagnostic tests
available for COVID-19, our solution enables clinicians and
researchers the ability to sequence and surveil the evolution of
mutations in the virus over time and geography. This is especially
significant at the moment as more variants are identified that are
more contagious,” 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 samples
together, providing actionable information that can then be used to
inform public health and clinical decisions.”
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 Assay was validated on a NextSeq® 550 Sequencing
System. Because the assay analyzes the full sequence data, the test
reduces the likelihood of a false-negative result. In contrast, a
majority of SARS-CoV-2 tests based on polymerase chain reaction
(PCR) only identify limited genetic markers of the virus.
In the separate and free RUO report, the full sequence of the
virus is profiled, enabling improved understanding of mutations,
genetic variability, and the evolution of the virus as it’s
transmitted. A recent pre-print on
MedRxiv and submitted for peer review details results of the NGS
SARS-CoV-2 Assay with the COVID-DX Solution to detect the virus and
its genetic variants.
"As SARS-CoV-2 continues to evolve, the need for insightful
research tools leveraging NGS and evolutionary principles has
become starkly clear,” commented Niamh O’Hara, Ph.D., CEO and
co-founder of Biotia. “This assay also greatly expands testing
options in the clinical space, bringing new technology to
patients.”
“This test opens the door to a new diagnostic method and can
also guide vaccine research, since it captures viral variants so
well,” noted Christopher Mason, Ph.D., co-founder of Biotia, “We
are elated to get an FDA EUA for our test, which 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 Test and Interface
The SARS-CoV-2 NGS Assay is an in vitro diagnostic test intended
for the qualitative identification of the SARS-CoV-2 virus from
nasopharyngeal (NP), oropharyngeal (OP), anterior nasal and
mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal
wash/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 Assay, which includes Twist
Bioscience’s SARS-CoV-2 synthetic RNA controls, along with the
Biotia COVID-DX software which generates a clinical report and RUO
report, covers the entire virus genome and identifies all strains
of SARS-CoV-2 in samples with as few as 800 viral copies per
milliliter.
The complementary Biotia COVID-DX software provides a
clinically-oriented report including the presence or absence of the
SARS-CoV-2 virus. FASTQ files (sequencing output) can be generated
in certified clinical laboratories and submitted to Biotia COVID-DX
(v1.0), a cloud-based software, to generate clinical reports.
Access to the Biotia COVID-DX software will be provided through a
unique order number emailed to a clinician or researcher that
includes credits for each kit purchased.
The SARS-CoV-2 NGS Assay and Biotia COVID-DX software are
limited to laboratories certified under the Clinical Laboratory
Improvement Amendments (CLIA) to perform high complexity tests. The
SARS-CoV-2 NGS Assay 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 Assay is only for use under the Food and Drug
Administration’s Emergency Use Authorization. This test will become
available for purchase in the coming weeks. For more information,
click here.
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
diseases 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 provide actionable information that can
then be used to inform public health and clinical decisions, reduce
the likelihood of a false positive or a false negative result,
enable improved understanding of mutations, genetic variability,
and the evolution of SARS-CoV-2 as it is transmitted and to 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; 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 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.
1Variant detection and identification performance have not been
evaluated by the FDA and these claims are not authorized under
FDA’s Emergency Use Authorization.
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version on businesswire.com: https://www.businesswire.com/news/home/20210324005311/en/
Twist Bioscience: Angela Bitting 925- 202-6211
abitting@twistbioscience.com
Biotia: Steve Capoccia 617-372-1539 spc@spcoms.com
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