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Twist Bioscience launches EU-compliant diagnostic products



 

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SOUTH SAN FRANCISCO, Calif. – Twist Bioscience (NASDAQ:TWST) Corporation (NASDAQ: TWST), a synthetic biology company, today announced the launch of its new Twist Precision Dx products, which comply with the European Union’s in vitro diagnostic regulations (IVDR). The suite of products is CE-marked, aligning with the EU IVDR 2017/746 regulations, which are aimed at ensuring the safety and quality of in vitro diagnostic medical devices.

The Twist Precision Dx products include the Twist Precision Prep and Enrichment Dx Kit, the Twist Precision Exome Dx Panel, and the Twist Precision Exome Dx Kit. These products are designed to facilitate panel sequencing within clinical settings, enabling laboratories to incorporate Twist’s next-generation sequencing (NGS) tools into their diagnostic tests.

The Twist Precision Prep and Enrichment Dx Kit is a reagent kit that combines enzymatic fragmentation and library preparation into a single-tube reaction, which is intended to enhance the quality of library preparation and sequencing results. It can be used with DNA panels supplied by users or with Twist’s DNA panels, such as the Twist Precision Exome Dx Panel.

The Twist Precision Exome Dx Panel, when used with the aforementioned kit, provides exome-enriched libraries for NGS applications, including coverage of the mitochondrial genome and other clinically relevant loci. The Twist Precision Exome Dx Kit combines both the panel and the reagent kit into a comprehensive solution for exome sequencing.

Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, stated that the launch of these IVDR-compliant products supports their European customers by providing a fully validated whole exome library preparation and target enrichment workflow. This move is expected to streamline the process for customers seeking IVDR certification for their diagnostic tests.

Additionally, Twist Bioscience has partnered with Platomics to offer documentation generation and regulatory process automation on Platomics’ platform for laboratories using the Twist Precision Exome Dx Kit.

This announcement is based on a press release statement from Twist Bioscience Corporation .

InvestingPro Insights

Twist Bioscience Corporation (NASDAQ: TWST), has made significant strides in the synthetic biology field with its recent launch of IVDR-compliant diagnostic products. Investors interested in the company’s financial health will find the following metrics from InvestingPro noteworthy:

  • The company’s market capitalization stands at $2.21 billion, reflecting its current valuation in the market.
  • Twist Bioscience’s revenue has shown a robust growth of 21.58% over the last twelve months as of Q1 2024, with quarterly growth reaching an impressive 31.81% in Q1 2024.
  • The stock has experienced substantial price appreciation, with a 55.01% return over the last three months and an even more impressive 96.71% return over the past year.

Investors should also consider these InvestingPro Tips for a deeper understanding of the company’s financial nuances:

  • Twist Bioscience holds more cash than debt on its balance sheet, which could provide financial flexibility and reduce risk for investors.
  • The company’s stock price movements are quite volatile, which may appeal to certain investors looking for high-growth potential despite the inherent risks.

For those considering an investment in Twist Bioscience, it’s worth noting that analysts do not anticipate the company will be profitable this year, and it does not pay a dividend to shareholders. However, its liquid assets exceed short-term obligations, which suggests the company has a solid liquidity position.

For additional insights, Twist Bioscience currently has more InvestingPro Tips available, which can be accessed by visiting InvestingPro. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription and explore the full range of expert analytics and tips.

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