Twist Bioscience Launches Circulating Tumor DNA Reference Controls for Development of Liquid Biopsy Assays
December 07 2021 - 7:00AM
Business Wire
– Represents First Industry Standard
Control for Cancer Testing –
Twist Bioscience Corporation (NASDAQ: TWST), a company enabling
customers to succeed through its offering of synthetic DNA using
its silicon platform, today announced the launch of the Twist cfDNA
Pan-cancer Reference Standards, a high-quality standardized control
for use in the development and continuous monitoring of liquid
biopsy tests to detect cancer from blood samples.
Liquid biopsy tests, which rely on NGS-based circulating tumor
DNA (ctDNA) analysis, are a promising and growing area in clinical
oncology. Liquid biopsy assays can accurately identify a single
tumor variant in the presence of thousands of healthy cells. The
most sought-after applications in the ctDNA field include early
detection of disease, personalization of therapy, monitoring
response to therapy, and monitoring for relapse of disease.
Developing and standardizing these ultra-sensitive yet accurate
ctDNA-based assays is paramount to ensure the resulting analysis
from the test informs clinical decisions reliably.
“As the number of clinical validations of liquid biopsies
increase, a true ctDNA pan-cancer reference standard, beyond the
few variants that are widely available today, will increase liquid
biopsies’ accuracy in detecting specific oncogenes and variants,”
said Florian Battke, director of development at CeGaT GmbH. “There
is an obvious benefit of using a synthetic approach like the Twist
ctDNA standards, as they are very high quality and closely mimic
the properties of real samples without the instability.”
The Twist cfDNA Pan-cancer Reference Standards material consists
of synthetically designed variant sequences that mimic ctDNA
combined with background DNA that is derived from, and closely
mimics, human-derived cell-free DNA (cfDNA).
This reference standard can be used by researchers to assist in
the development of liquid biopsy assays to establish the analytical
limit of detection (LoD) for specific cancer variants and as a
control to track the quality of an NGS assay workflow to ensure the
fidelity of the assay process.
The Twist cfDNA Pan-cancer Reference Standards can be used
within the liquid biopsy workflow, which includes Twist Library
Preparation Kit and the Twist Mechanical Fragmentation Kit, for
maximum efficacy and provides a large and diverse number of
clinically relevant variants, combining best in class methods for
variant synthesis with unrivaled control over the specific target
allele frequencies in a format which closely mimics the size
distribution and fragmentation profile of cfDNA. In contrast,
traditional reference standards are limited in the number and
variation of variants and typically use cell line-derived DNA which
can carry unwanted sequence variations and variable fragment
length.
Emily Leproust, CEO and co-founder of Twist Bioscience said,
“Building on the success of our SARS-CoV-2 positive controls that
are now used in COVID-19 tests worldwide, we believe having precise
standard cancer reference controls that can be used in a validated
workflow will be a gamechanger to confirm clinical insights from
genetic information. While it is possible to create cell-based
controls specific to each test, using a robust, precise control set
that detects variation in test assays will be pivotal in both
development and ongoing monitoring of a wide variety of liquid
biopsy assays.”
Applying the right reference materials is essential to benchmark
the complexity and biological content of DNA found in liquid biopsy
samples for assay development and validation. The Twist ctDNA
reference material contains over 400 variants, including SNVs,
indels, fusions and structural variants, as well as more than 140
clinically relevant variants. All variants are offered with a
unique tiling design, which accurately mimics the pattern of
naturally derived ctDNAs. All of these features make the Twist
ctDNA reference a high-quality standard for the ctDNA variants that
cancer liquid biopsy assays are designed to detect.
To demonstrate the limit of detection (LoD) of an ultra
sensitive NGS-based liquid biopsy assay, using an accurately
quantified ctDNA control is key. Twist’s silicon platform provides
an advantage by specifically writing individual variants of
interests, thus preventing any interference caused by contaminants
derived from cell culture-based methods. Twist’s ctDNA reference
material is also well-characterized and quantified, using
industry-standard and proprietary methods (NGS, ddPCR, and
fluorescence-based quantification).
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.
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 expected impact of the
Twist ctDNA reference standards, 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; the retention of employees of acquired companies
and the ability of Twist Bioscience to successfully integrate
acquired companies and to achieve expected benefits, 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 23,
2021, 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 because
of new information, future events or otherwise.
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Angela Bitting Twist Bioscience (925) 202-6211
abitting@twistbioscience.com
Twist Bioscience (NASDAQ:TWST)
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