Azenta Obtains Regulatory Approval for Clinical Long-Read Whole Genome Sequencing Test
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.
Azenta (Nasdaq: AZTA) è diventata il primo fornitore commerciale a ricevere l'approvazione normativa per un test clinico di sequenziamento dell'intero genoma (WGS) a lettura lunga negli Stati Uniti. Il test, che utilizza il sequenziatore Revio di PacBio per il sequenziamento HiFi, viene eseguito nel laboratorio di genomica clinica accreditato CLIA e CAP di GENEWIZ. Questa innovazione consente una rilevazione precisa delle alterazioni genomiche complesse associate a malattie rare che di solito risultano indetectabili attraverso i metodi tradizionali di sequenziamento a lettura corta. La tecnologia fornisce un'analisi genomica completa catturando lunghe sequenze di DNA in letture singole, migliorando l'accuratezza diagnostica per le malattie rare.
Azenta (Nasdaq: AZTA) se ha convertido en el primer proveedor comercial en recibir la aprobación regulatoria para una prueba clínica de secuenciación del genoma completo (WGS) de lectura larga en los Estados Unidos. La prueba, que utiliza el secuenciador Revio de PacBio para secuenciación HiFi, se realiza en el laboratorio de genómica clínica acreditado por CLIA y CAP de GENEWIZ. Este avance permite la detección precisa de alteraciones genómicas complejas asociadas con enfermedades raras que generalmente son indetectables a través de métodos tradicionales de secuenciación de lectura corta. La tecnología proporciona un análisis genómico completo al capturar largas extensiones de ADN en lecturas individuales, mejorando la precisión diagnóstica para enfermedades raras.
Azenta (Nasdaq: AZTA)는 미국에서 임상 장기 읽기 전체 유전체 시퀀싱(WGS) 테스트에 대한 규제 승인을 받은 최초의 상업 제공자가 되었습니다. 이 테스트는 PacBio의 Revio 시퀀서를 사용하여 HiFi 시퀀싱을 수행하며, GENEWIZ의 CLIA 인증 및 CAP 인가 임상 유전체학 실험실에서 수행됩니다. 이 획기적인 기술은 전통적인 짧은 읽기 시퀀싱 방법으로는 일반적으로 탐지할 수 없는 희귀 질환과 관련된 복잡한 유전체 변화를 정확하게 탐지할 수 있게 합니다. 이 기술은 단일 읽기로 긴 DNA 구간을 캡처하여 포괄적인 유전체 분석을 제공하고, 희귀 질환에 대한 진단 정확성을 향상시킵니다.
Azenta (Nasdaq: AZTA) est devenu le premier fournisseur commercial à recevoir l'approbation réglementaire pour un test clinique de séquençage du génome entier (WGS) à lecture longue aux États-Unis. Le test, utilisant le séquenceur Revio de PacBio pour le séquençage HiFi, est effectué dans le laboratoire de génomique clinique certifié CLIA et accrédité CAP de GENEWIZ. Cette avancée permet la détection précise d’altérations génomiques complexes associées à des maladies rares, généralement indétectables par les méthodes traditionnelles de séquençage à lecture courte. La technologie fournit une analyse complète du génome en capturant de longues séquences d'ADN dans des lectures uniques, améliorant ainsi la précision diagnostique pour les maladies rares.
Azenta (Nasdaq: AZTA) ist der erste kommerzielle Anbieter, der in den Vereinigten Staaten die behördliche Genehmigung für einen klinischen Langlesegenomsequenzierungstest (WGS) erhalten hat. Der Test, der den Revio-Sequenzer von PacBio für HiFi-Sequenzierung nutzt, wird im CLIA-zertifizierten und CAP-akkreditierten klinischen Genomiklabor von GENEWIZ durchgeführt. Dieser Durchbruch ermöglicht die präzise Erkennung komplexer genomischer Veränderungen, die mit seltenen Krankheiten assoziiert sind und die normalerweise durch traditionelle Kurzlesesequenzierungsmethoden nicht erkannt werden können. Die Technologie bietet eine umfassende Genomanalyse, indem sie lange DNA-Abschnitte in einzelnen Lesungen erfasst und die diagnostische Genauigkeit für seltene Krankheiten verbessert.
- 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
- None.
Insights
This regulatory milestone marks a significant advancement in clinical genomics testing. The approval of long-read WGS testing provides superior detection capabilities for complex genetic variants, particularly in repetitive regions that are important for rare disease diagnosis. The partnership with PacBio's Revio platform enhances Azenta's competitive position as the first commercial provider with regulatory approval in the U.S.
The technology's ability to capture extended DNA sequences in single reads represents a substantial improvement over traditional short-read methods. This breakthrough could accelerate rare disease diagnosis rates and potentially expand Azenta's market share in the
Being first-to-market with regulatory approval for clinical long-read WGS testing gives Azenta a significant competitive advantage in the growing precision medicine sector. This positions the company to capture market share in the expanding rare disease diagnostics segment, where improved accuracy can command premium pricing. The collaboration with PacBio, a leader in long-read sequencing technology, strengthens Azenta's market position and could lead to increased revenue streams from both diagnostic services and potential pharmaceutical research partnerships.
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
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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