Azenta Obtains Regulatory Approval for Clinical Long-Read Whole Genome Sequencing Test

Rhea-AI Summary

Azenta (Nasdaq: AZTA) has become the first commercial provider to receive regulatory approval for a clinical long-read Whole Genome Sequencing (WGS) test in the United States. The test, utilizing PacBio's Revio sequencer for HiFi sequencing, is performed in GENEWIZ's CLIA-certified and CAP-accredited clinical genomics laboratory. This breakthrough enables precise detection of complex genomic alterations associated with rare diseases that are typically undetectable through traditional short-read sequencing methods. The technology provides comprehensive genome analysis by capturing long DNA stretches in single reads, enhancing diagnostic accuracy for rare diseases.

Positive

• First-mover advantage as the only approved commercial provider of clinical long-read WGS testing in the US
• Strategic partnership with PacBio leveraging advanced Revio sequencer technology
• Enhanced diagnostic capabilities for rare diseases through superior genomic analysis

Negative

• None.

BURLINGTON, Mass., Oct. 30, 2024 /PRNewswire/ -- Azenta, Inc. (Nasdaq: AZTA) today announced the launch of a long-read Whole Genome Sequencing (WGS) test for clinical applications. Azenta becomes the first commercial provider to obtain regulatory approval to offer this test in the United States. 

Traditional short-read sequencing methods often struggle with identifying genetic variants in repetitive regions of the genome that underpin many rare diseases, hindering accurate diagnoses and targeted treatments. In contrast, Azenta's test makes use of PacBio's Revio sequencer to obtain long and highly accurate HiFi sequencing reads to cover regions that are inaccessible by short reads. Performed within GENEWIZ from Azenta Life Sciences CLIA certified and CAP accredited state-of-the-art clinical genomics laboratory, the test enables precise detection of a range of complex genomic alterations that are features of many rare diseases and undetectable by traditional approaches. This allows for a view of the genome with unprecedented comprehensiveness.

"Clinical-grade long-read sequencing represents a monumental leap forward in the ability to decipher the genetic basis of rare diseases. By capturing long stretches of DNA in a single read, researchers can uncover subtle genetic nuances that were previously undetectable with conventional methods," said Dr. Ginger Zhou, Senior Vice President & General Manager – GENEWIZ Multiomics and Synthesis Solutions from Azenta Life Sciences. "This capability not only enhances diagnostic accuracy but also opens new avenues for developing targeted therapies and conducting more effective clinical trials."

"Azenta's test highlights the power of PacBio's technology in generating the most accurate and comprehensive genomic data available today," said Christian Henry, President and Chief Executive Officer of PacBio. "Revio's highly accurate HiFi reads are having an increasingly significant impact, allowing researchers to uncover the complex intricacies of rare diseases. We are proud to support their innovative work in expanding what's possible in clinical applications with these deeper, more precise views of the genome."

Learn about our Long-Read Whole Genome Sequencing Test by visiting us at booth #422 at the American Society of Human Genetics (ASHG) Conference on November 5-9 in Denver, CO. For more information, please visit https://www.genewiz.com/en/Public/Services/Clinical-Services

About Azenta Life Sciences

Azenta, Inc. (Nasdaq: AZTA) is a leading provider of life sciences solutions worldwide, enabling impactful breakthroughs and therapies to market faster. Azenta provides a full suite of reliable cold-chain sample management solutions and multiomics services across areas such as drug development, clinical research and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. Our global team delivers and supports these products and services through our industry-leading brands, including GENEWIZ, FluidX, Ziath, 4titude, Limfinity, Freezer Pro, Barkey and B Medical Systems.

Azenta is headquartered in Burlington, MA, with operations in North America, Europe and Asia. For more information, please visit www.azenta.com.

"Safe Harbor Statement" under Section 21E of the Securities Exchange Act of 1934

Some statements in this release are forward-looking statements made under Section 21E of the Securities Exchange Act of 1934. These statements are neither promises nor guarantees but involve risks and uncertainties, both known and unknown, that could cause Azenta's financial and business results to differ materially from our expectations. They are based on the facts known to management at the time they are made. Forward-looking statements include but are not limited to statements about the potential benefits of Azenta's long-read Whole Genome Sequencing (WGS) test for clinical applications. Factors that could cause results to differ from our expectations include the following: our ability to perform the long-read WGS test, the performance of the sequencing equipment used in conducting the long-read WGS test, and the ability of our customers to develop new therapies using the long-read WGS test and other factors and other risks, including those that we have described in our filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K, Current Reports on Form 8-K and our Quarterly Reports on Form 10-Q. As a result, we can provide no assurance that our future results will not be materially different from those projected. Azenta expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statement to reflect any change in our expectations or any change in events, conditions, or circumstances on which any such statement is based. Azenta undertakes no obligation to update the information contained in this press release.

INVESTOR CONTACTS:
Yvonne Perron
Vice President, Financial, Planning & Analysis and Investor Relations
ir@azenta.com

Sherry Dinsmore
sherry.dinsmore@azenta.com

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SOURCE Azenta

FAQ

What regulatory approval did Azenta (AZTA) receive in October 2023?

Azenta received regulatory approval to become the first commercial provider of clinical long-read Whole Genome Sequencing (WGS) testing in the United States.

What technology does Azenta (AZTA) use for its new WGS test?

Azenta uses PacBio's Revio sequencer to obtain long and highly accurate HiFi sequencing reads for their WGS test.

What advantage does Azenta's (AZTA) long-read WGS test offer over traditional methods?

The test enables precise detection of complex genomic alterations in rare diseases that are typically undetectable through traditional short-read sequencing methods.

Where is Azenta's (AZTA) new WGS test performed?

The test is performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited clinical genomics laboratory.