Twist Bioscience Launches IVDR-compliant Precision Dx Products for Whole Exome Sequencing
March 05 2024 - 8:00AM
Business Wire
Precision Dx Products are CE-marked and
compliant with EU IVDR 2017/746 regulations
Precision Dx Products include Twist Precision
Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel and
Twist Precision Exome Dx Kit
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 European Union (EU)
in vitro diagnostic regulations (IVDR) compliant Twist Precision Dx
next-generation sequencing (NGS) Products.
In accordance with the IVD regulations put in place by the EU to
ensure the safety and quality of in vitro diagnostic medical
devices, Twist’s Precision Dx Products are CE-marked and compliant
with EU IVDR 2017/746 regulations demonstrating the quality of kit
materials. The Precision Dx products are designed to enable panel
sequencing within a clinical setting.
The suite of our CE-marked Products includes:
- The Twist Precision Prep and Enrichment Dx Kit1 (Reagents for
enzymatic fragmentation, library preparation, and target
enrichment), which is panel-agnostic2
- The Twist Precision Exome Dx Panel1 (Targeted capture probes
for exome enrichment)
- Twist Precision Exome Dx Kit1 (Reagents for enzymatic
fragmentation, library preparation, and target enrichment along
with targeted capture probes for exome enrichment; IVDR compliant
workflow)
The Twist Precision Prep and Enrichment Dx Kit and the Twist
Precision Exome Dx Panel can be used individually within existing
workflows or as a combined solution known as the Twist Precision
Exome Dx Kit. In addition, as an added service to customers, Twist
is collaborating with Platomics to enable laboratories to
efficiently generate documentation on Platomics’ multi-stakeholder
platform for workflows incorporating the Twist Precision Exome Dx
Kit, and to help automate regulatory processes and accelerate
compliance for laboratories and manufacturers.
“The Twist Precision Dx products are our first NGS product line
specifically developed to be included within regulated customer
products. With IVD regulation in place and an expanding customer
base in EMEA, we’ve launched one of the first comprehensive,
fully-validated whole exome library preparation and target
enrichment workflows to enable our customers to seamlessly obtain
IVDR certification for their diagnostic tests,” said Emily M.
Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “By taking
the steps to have our exome workflow IVDR certified ahead of the
transition deadline for existing tests, we continue to support our
current customers in Europe developing clinical tests using Twist
NGS tools while also expanding our market opportunity to include
regulated test workflows. With multiple CE-marked Products, we can
support our European customers in several ways, either by providing
panel-agnostic library prep and target enrichment for their
existing panels, an exome workflow for their existing workflows or
a combined solution for an IVDR-compliant workflow.”
The Precision Dx workflow enables comprehensive coverage with
more than 98% of target bases covered at 30x as well as reliable
performance with uniform enrichment and consistent yield from
high-complexity libraries. The Precision Dx Products are intended
for use with high-quality genomic DNA derived from human cells and
allow for flexibility within workflows.
Twist Precision Prep and Enrichment Dx Kit
The Twist Precision Prep and Enrichment Dx Kit1 is a reagent kit
that includes enzymatic fragmentation, library preparation, and
targeted capture. It utilizes Twist’s expertise in enzymatic DNA
fragmentation and library preparation to enable reliable access to
target DNA for NGS. The kit’s streamlined workflow combines library
preparation steps into a single-tube reaction which, alongside a
high on-target rate and Twist’s highly uniform target enrichment
workflow, translates into an enhanced quality library preparation
and sequencing result. The kit can be used to target specific
regions of the genome with DNA panels supplied by users or with a
Twist DNA panel, such as the Twist Precision Exome Dx Panel, for
NGS applications.
Twist Precision Exome Dx Panel
The Twist Precision Exome Dx Panel1 is a qualified Twist DNA
panel that can be used in conjunction with the Twist Precision Prep
and Enrichment Dx kit to produce exome-enriched libraries
compatible for NGS applications. The panel expands exonic coverage
to include the mitochondrial genome as well as additional
clinically relevant loci, providing efficient and comprehensive
exome sequencing for improved coverage of target sequences.
Twist Precision Exome Dx Kit
Twist Precision Exome Dx Kit1 utilizes the qualified Twist
Precision Exome Dx Panel along with the Twist Precision Prep and
Enrichment Dx Kit to produce exome-enriched libraries compatible
for NGS applications.
1
For in vitro diagnostic use. Not
available in all regions and countries.
2
Panels supplied by users must
meet Twist specifications, available upon request.
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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Twist Bioscience Legal Notice Regarding Forward-Looking
Statements
This press release contains forward-looking statements. All
statements other than statements of historical facts contained
herein 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, including, but not limited to, statements regarding our
ability to help customers seamlessly obtain IVDR certification for
their diagnostic tests and the usefulness of Platomics’
multi-stakeholder platform for automating regulatory processes,
documentation generation and compliance. 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 ability to achieve the expected benefits
of Twist Bioscience’s restructuring activities and reduced
investments in DNA data storage; the ability to attract new
customers and retain and grow sales from existing customers; the
ability of Twist Bioscience to achieve sufficient revenue to
achieve or maintain positive cash flow from operations or
profitability in any given period; risks and uncertainties of
rapidly changing technologies and extensive competition in
synthetic biology that could make the products Twist Bioscience is
developing obsolete or non-competitive; uncertainties of the
retention of significant customers; the ability of Twist Bioscience
to successfully integrate acquired companies and to achieve
expected benefits from acquisitions; supply chain and other
disruptions; 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 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 February
2, 2024 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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version on businesswire.com: https://www.businesswire.com/news/home/20240305710562/en/
For Investors: Angela Bitting SVP, Corporate Affairs
925-202-6211 abitting@twistbioscience.com For Media: Amanda
Houlihan Communications Manager 774-265-5334
ahoulihan@twistbioscience.com
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