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

14 November 2024 -- Massachusetts, US -- Azenta, Inc 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."

For more information, please visit genewiz.com/en/Public/Services/Clinical-Services

About Azenta Life Sciences
Azenta, Inc 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.