Tempus Announces Its First-Ever, Whole-Genome Sequencing Assay, xH
Tempus AI (NASDAQ: TEM) announced the development of xH, its first whole-genome sequencing (WGS) test, focusing on hematological oncology. The test, currently available for research use only, will be clinically available within the next year. xH is designed to support both clinicians and biopharma collaborators by providing comprehensive genetic profiling.
In a pilot study of 135 patients, the WGS assay demonstrated high accuracy with a concordance rate exceeding 98.9% compared to traditional molecular methods. The test showed particular effectiveness in detecting guideline-recommended structural variants and large copy number alterations in myeloid malignancies, including Acute Myeloid Leukemia, Myelodysplastic Syndromes, and Myeloproliferative neoplasms. This comprehensive approach aims to consolidate multiple tests into a single assay, potentially offering a more cost-effective solution for genomic profiling.
Tempus AI (NASDAQ: TEM) ha annunciato lo sviluppo di xH, il suo primo test di sequencing dell'intero genoma (WGS), focalizzato sull'oncologia ematologica. Il test, attualmente disponibile solo per uso di ricerca, sarà clinicamente disponibile entro il prossimo anno. xH è progettato per supportare sia i clinici che i collaboratori biopharma fornendo un profilo genetico completo.
In uno studio pilota di 135 pazienti, l'assay WGS ha dimostrato un'alta precisione con un tasso di concordanza superiore al 98,9% rispetto ai metodi molecolari tradizionali. Il test ha mostrato particolare efficacia nella rilevazione di varianti strutturali raccomandate dalle linee guida e di grandi alterazioni nel numero di copie nelle neoplasie mieloidi, tra cui la leucemia mieloide acuta, le sindromi mielodisplastiche e le neoplasie mieloproliferative. Questo approccio completo mira a consolidare più test in un unico assay, offrendo potenzialmente una soluzione più economica per il profiling genomico.
Tempus AI (NASDAQ: TEM) anunció el desarrollo de xH, su primera prueba de secuenciación del genoma completo (WGS), centrada en la oncología hematológica. La prueba, actualmente disponible solo para fines de investigación, estará disponible clínicamente dentro del próximo año. xH está diseñado para apoyar tanto a los clínicos como a los colaboradores de biopharma al proporcionar un perfil genético integral.
En un estudio piloto de 135 pacientes, el ensayo WGS demostró una alta precisión con una tasa de concordancia superior al 98.9% en comparación con los métodos moleculares tradicionales. La prueba mostró una efectividad particular para detectar variantes estructurales recomendadas por las guías y grandes alteraciones en el número de copias en las malignidades mieloides, incluida la leucemia mieloide aguda, los síndromes mielodisplásicos y las neoplasias mieloproliferativas. Este enfoque integral tiene como objetivo consolidar múltiples pruebas en un único ensayo, ofreciendo potencialmente una solución más rentable para el perfilado genómico.
Tempus AI (NASDAQ: TEM)은 혈액 종양학에 중점을 둔 첫 번째 전체 유전체 분석(WGS) 테스트인 xH의 개발을 발표했습니다. 현재 연구용으로만 제공되는 이 테스트는 내년 안에 임상적으로 사용할 수 있게 될 것입니다. xH는 포괄적인 유전적 프로파일링을 제공하여 임상의와 바이오 제약 협력자 모두를 지원하도록 설계되었습니다.
135명의 환자를 대상으로 한 파일럿 연구에서 WGS 분석은 전통적인 분자 방법에 비해 98.9% 이상의 일치율을 보이며 높은 정확성을 입증했습니다. 이 테스트는 급성 골수성 백혈병, 골수형성이상증후군 및 골수증식성 신생물과 같은 골수 악성과 관련된 가이드라인 추천 구조 변이 및 대규모 복제 수 변화를 탐지하는 데 특히 효과적이었습니다. 이 포괄적인 접근 방식은 여러 테스트를 하나의 분석으로 통합하는 것을 목표로 하여 유전체 프로파일링에 대한 보다 비용 효율적인 솔루션을 제공할 가능성이 있습니다.
Tempus AI (NASDAQ: TEM) a annoncé le développement de xH, son premier test de séquençage du génome complet (WGS), axé sur l'oncologie hématologique. Le test, actuellement disponible uniquement à des fins de recherche, sera cliniquement disponible dans l'année à venir. xH est conçu pour soutenir à la fois les cliniciens et les collaborateurs biopharma en fournissant un profilage génétique complet.
Lors d'une étude pilote sur 135 patients, l'essai WGS a montré une grande précision avec un taux de concordance dépassant 98,9 % par rapport aux méthodes moléculaires traditionnelles. Le test a montré une efficacité particulière dans la détection des variations structurelles recommandées par les lignes directrices et des altérations importantes du nombre de copies dans les malignités myéloïdes, y compris la leucémie myéloïde aiguë, les syndromes myélodysplasiques et les néoplasies myéloprolifératives. Cette approche globale vise à consolider plusieurs tests en un seul essai, offrant potentiellement une solution plus rentable pour le profilage génomique.
Tempus AI (NASDAQ: TEM) hat die Entwicklung von xH, seinem ersten Test zur Vollgenomsequenzierung (WGS), bekannt gegeben, der sich auf die hämatologische Onkologie konzentriert. Der Test, der derzeit nur für Forschungszwecke verfügbar ist, wird innerhalb des nächsten Jahres klinisch verfügbar sein. xH ist darauf ausgelegt, sowohl Kliniker als auch Biopharma-Partner zu unterstützen, indem er ein umfassendes genetisches Profiling bereitstellt.
In einer Pilotstudie mit 135 Patienten zeigte der WGS-Test eine hohe Genauigkeit mit einer Übereinstimmungsrate von über 98,9 % im Vergleich zu traditionellen molekularen Methoden. Der Test zeigte eine besondere Effektivität bei der Erkennung von strukturellen Varianten, die in den Richtlinien empfohlen werden, sowie großen Kopiezahlveränderungen bei myeloischen Malignitäten, einschließlich akuter myeloischer Leukämie, myelodysplastischer Syndrome und myeloproliferativer Neoplasien. Dieser umfassende Ansatz zielt darauf ab, mehrere Tests in einem einzigen Assay zu konsolidieren und möglicherweise eine kostengünstigere Lösung für die genomische Profilierung anzubieten.
- High accuracy demonstrated with 98.9% concordance rate in pilot study
- Cost-effective solution by consolidating multiple tests into single assay
- Expansion into whole-genome sequencing market
- Product currently to research use only
- Clinical availability delayed until next year
Insights
The launch of Tempus' whole-genome sequencing test xH represents a significant technological advancement in precision oncology. The pilot study's 98.9% concordance rate with traditional methods validates its accuracy, while the ability to detect multiple mutation types in a single test offers substantial cost and efficiency benefits.
This development is particularly noteworthy for several reasons: First, consolidating multiple tests into one comprehensive assay could significantly reduce diagnostic costs and turnaround time. Second, the technology's application in hematological malignancies addresses a critical market need, as these cancers often require complex genetic analysis for proper treatment selection. Third, the research-use-only (RUO) status with planned clinical availability within a year suggests a clear commercialization pathway.
Think of xH as a high-definition camera that can capture the entire genetic landscape in one shot, compared to traditional methods that take multiple, focused snapshots. This comprehensive view could revolutionize how we detect and treat blood cancers, potentially leading to more precise treatment matches and better patient outcomes.
From a market perspective, Tempus' entry into whole-genome sequencing positions the company to capture a larger share of the rapidly growing precision medicine market. The timing is strategic, as the global precision medicine market is experiencing substantial growth, driven by increasing adoption of personalized therapies and advancing AI capabilities.
The development has several key business implications: 1) Potential for increased revenue streams through both clinical testing services and biopharma partnerships, 2) Enhanced competitive positioning against other precision medicine companies and 3) Creation of valuable proprietary datasets that could drive future AI-powered innovations and partnerships.
The comprehensive nature of xH could translate into higher per-test revenue compared to traditional targeted sequencing approaches. Moreover, the technology's application in research settings provides an immediate revenue opportunity while awaiting clinical approval, demonstrating a well-thought-out market entry strategy.
The integration of AI with whole-genome sequencing represents a powerful technological convergence. The key technical differentiator lies in Tempus' ability to process and analyze the massive amounts of data generated by whole-genome sequencing using their existing AI infrastructure.
From a technical standpoint, whole-genome sequencing generates approximately 100 times more data than targeted panel sequencing. Tempus' ability to effectively process this data and extract clinically relevant insights demonstrates significant computational capabilities. The high concordance rate (>98.9%) suggests robust bioinformatics pipelines and machine learning algorithms.
For investors, this represents more than just a new diagnostic test - it's a strategic expansion of Tempus' data moat. Each genome sequenced adds to their proprietary database, potentially improving their AI models and creating a virtuous cycle of increasingly valuable insights.
With xH, Tempus builds on its AI-enabled diagnostic platform, extending a comprehensive approach that will facilitate personalized treatment decisions and a more precise understanding of patients' unique genetic profiles. xH, which is currently available for research use only (RUO) and will be clinically available within the next year, is also designed to support Tempus' biopharma collaborators, equipping researchers with the unique insights that can only come from sequencing the whole genome.
“xH is our first product leveraging the full genome in our effort to provide meaningful insights into complex diseases,” said Eric Lefkofsky, Founder and CEO of Tempus. “By scaling whole-genome sequencing, we are positioned to transform patient care in hematological oncology and eventually all solid tumors, shaping the future of precision medicine and accelerating therapeutic advancements in partnership with the pharmaceutical community.”
Tempus has developed a comprehensive whole-genome sequencing assay optimized for myeloid malignancies, demonstrating high sensitivity in detecting clinically-relevant genetic alterations across Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Myeloproliferative neoplasms (MPN), and other hematological malignancies. In a pilot study of 135 patients, the WGS assay identified a broad array of mutation types with a concordance rate over
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential impact of xH and other tests, the indicated use of the xH and other tests for potential clinical use, and the timing of the availability of such testing. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
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Erin Caron
media@tempus.com
773-612-4414
Source: Tempus AI, Inc.
FAQ
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