Twist Bioscience Launches IVDR-compliant Precision Dx Products for Whole Exome Sequencing
Twist Bioscience Corporation (NASDAQ: TWST) announces CE-marked Precision Dx Products compliant with EU IVDR regulations, including Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel, and Twist Precision Exome Dx Kit. The products aim to facilitate panel sequencing within clinical settings, meeting high quality standards. Twist collaborates with Platomics to streamline documentation generation and regulatory compliance. CEO Emily M. Leproust highlights the significance of IVDR certification for diagnostic tests and the company's commitment to supporting European customers.
The announcement by Twist Bioscience Corporation regarding their new Precision Dx Products adhering to the EU's IVDR regulations represents a strategic move to expand their presence within the European diagnostics market. The CE marking signifies that the products meet EU standards for health, safety and environmental protection, which can be a crucial factor in gaining market acceptance. From a market research perspective, this compliance could potentially open doors for increased adoption of Twist's products by European clinical laboratories and diagnostic test developers, who are mandated to use IVDR-compliant tools and reagents.
Moreover, the collaboration with Platomics to streamline regulatory documentation and compliance processes is a value-added service that could differentiate Twist from competitors, potentially reducing the time and resources customers spend on regulatory affairs. This could enhance customer loyalty and attract new clients looking for efficient compliance solutions. The market opportunity for Twist is likely to grow as the demand for personalized medicine and genetic testing continues to rise and regulatory-compliant products become a necessity.
From a medical research perspective, the Precision Dx Products suite, including the Twist Precision Prep and Enrichment Dx Kit and the Twist Precision Exome Dx Panel, enables high-complexity genomic studies within a clinical setting. The ability to achieve over 98% coverage of target bases at 30x depth is significant, as it ensures comprehensive genetic information for diagnostic purposes. The inclusion of the mitochondrial genome and other clinically relevant loci in the exome panel broadens the scope of potential diagnostic applications, which could lead to more accurate and inclusive genetic testing.
Additionally, the single-tube library preparation workflow and the high on-target rate can streamline laboratory processes, potentially reducing errors and turnaround times for diagnostic tests. This level of efficiency and quality in library preparation and sequencing is crucial for clinical diagnostics, where accuracy and speed are paramount. The IVDR compliance of these products also ensures that they adhere to stringent safety and performance standards, which is essential for patient safety and diagnostic reliability.
Twist Bioscience Corporation's announcement of their IVDR-compliant Precision Dx Products could have notable financial implications for the company. Compliance with the EU's IVDR, which is more stringent than previous directives, requires significant investment in product development and validation. However, this investment can be seen as a strategic positioning to capture a larger share of the European market, which could lead to increased revenue streams in the long term.
The cost efficiencies gained from the streamlined workflows and the collaboration with Platomics may also contribute to a competitive pricing strategy, potentially improving profit margins. Investors and stakeholders should monitor the adoption rate of these products in the European market, as it will be a key indicator of the success of Twist Bioscience's strategic initiative. While there could be initial expenses associated with the launch and marketing of these products, the long-term benefits of establishing a strong foothold in the regulated European market could outweigh these costs.
03/05/2024 - 08:00 AM
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
SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--
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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Source: Twist Bioscience Corporation
What products are included in Twist Bioscience's Precision Dx line compliant with EU IVDR regulations?
The products included in Twist Bioscience's Precision Dx line compliant with EU IVDR regulations are Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel, and Twist Precision Exome Dx Kit.
What is the significance of the CE-marked Twist Precision Dx Products?
The CE-marked Twist Precision Dx Products demonstrate compliance with EU IVDR regulations, ensuring the safety and quality of in vitro diagnostic medical devices.
How does Twist collaborate with Platomics to assist customers?
Twist collaborates 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.
What coverage does the Precision Dx workflow offer?
The Precision Dx workflow enables comprehensive coverage with more than 98% of target bases covered at 30x, ensuring reliable performance with uniform enrichment and consistent yield from high-complexity libraries.
What is included in the Twist Precision Prep and Enrichment Dx Kit?
The Twist Precision Prep and Enrichment Dx Kit includes enzymatic fragmentation, library preparation, and targeted capture, utilizing Twist's expertise in enzymatic DNA fragmentation and library preparation to enable reliable access to target DNA for NGS.
