Tempus Announces the National Launch of FDA-Approved xT CDx Test
Tempus AI (NASDAQ: TEM) has announced the nationwide launch of its FDA-approved xT CDx test, a comprehensive 648-gene next-generation sequencing test for solid tumor profiling. The test includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
The xT CDx employs a normal-matched approach, conducting parallel DNA sequencing of solid tumor and normal patient samples for more accurate identification of cancer-driving somatic variants. All existing tumor + normal match tests previously run on Tempus's signature xT assay will now be processed as xT CDx, maintaining the current ordering workflow.
Clinicians can enhance molecular insights by combining xT CDx with additional tests including xR RNA sequencing, xF/xF+ liquid biopsy, immunohistochemistry tests, and algorithmic tests for homologous recombination deficiency and immune profile scoring.
Tempus AI (NASDAQ: TEM) ha annunciato il lancio a livello nazionale del suo test xT CDx approvato dalla FDA, un test completo di sequenziamento di nuova generazione su 648 geni per il profilo dei tumori solidi. Il test include lo stato di instabilità dei microsatelliti e affermazioni diagnostiche companion per i pazienti affetti da cancro del colon-retto.
Il xT CDx impiega un approccio abbinato a campioni normali, conducendo il sequenziamento parallelo del DNA di campioni tumorali solidi e di pazienti normali per identificare più accuratamente le varianti somatiche che guidano il cancro. Tutti i test tumorali + normali esistenti precedentemente eseguiti sul test xT distintivo di Tempus saranno ora elaborati come xT CDx, mantenendo il flusso di ordinazione attuale.
I clinici possono migliorare le intuizioni molecolari combinando l'xT CDx con test aggiuntivi, inclusi il sequenziamento RNA xR, la biopsia liquida xF/xF+, test di immunoistochimica e test algoritmici per la carenza di ricombinazione omologa e la valutazione del profilo immunitario.
Tempus AI (NASDAQ: TEM) ha anunciado el lanzamiento a nivel nacional de su test xT CDx aprobado por la FDA, una prueba integral de secuenciación de nueva generación de 648 genes para el perfilado de tumores sólidos. La prueba incluye el estado de inestabilidad de microsatélites y reclamos de diagnóstico complementario para pacientes con cáncer colorrectal.
El xT CDx emplea un enfoque de coincidencia con muestras normales, realizando secuenciación paralela de ADN de muestras de tumor sólido y de pacientes normales para una identificación más precisa de las variantes somáticas que impulsan el cáncer. Todas las pruebas de tumor + normal que se realizaron anteriormente en el ensayo distintivo xT de Tempus ahora se procesarán como xT CDx, manteniendo el flujo de pedidos actual.
Los clínicos pueden mejorar los conocimientos moleculares combinando xT CDx con pruebas adicionales que incluyen secuenciación de ARN xR, biopsia líquida xF/xF+, pruebas de inmunohistoquímica y pruebas algorítmicas para deficiencia de recombinación homóloga y evaluación del perfil inmunológico.
템퍼스 AI (NASDAQ: TEM)는 FDA의 승인을 받은 xT CDx 테스트의 전국 출시를 발표했습니다. 이 테스트는 고형 종양 프로파일링을 위한 648개 유전자 차세대 염기서열 분석 테스트입니다. 이 테스트는 미소위성 불안정성 상태 및 대장암 환자를 위한 동반 진단 청구를 포함합니다.
xT CDx는 일반 샘플과의 일치 방식을 사용하여 고형 종양과 정상 환자 샘플의 DNA를 병렬로 염기서열 분석하여 암 원인 변이를 더욱 정확하게 식별합니다. 템퍼스의 시그니처 xT 검사에서 이전에 수행된 모든 기존 종양 + 정상 일치 테스트는 이제 xT CDx로 처리되어 현재의 주문 워크플로를 유지합니다.
클리니션은 xT CDx를 xR RNA 염기서열 분석, xF/xF+ 액체 생검, 면역 조직화학 검사, 동종 재조합 결핍 및 면역 프로파일 점수를 위한 알고리즘 검사와 같은 추가 테스트와 결합하여 분자 통찰력을 향상시킬 수 있습니다.
Tempus AI (NASDAQ: TEM) a annoncé le lancement national de son test xT CDx approuvé par la FDA, un test complet de séquençage de nouvelle génération sur 648 gènes pour le profilage des tumeurs solides. Le test comprend le statut d'instabilité des microsatellites et des revendications de diagnostic compagnon pour les patients atteints de cancer colorectal.
Le xT CDx adopte une approche appariée à des échantillons normaux, en effectuant un séquençage parallèle de l'ADN des échantillons de tumeur solide et des échantillons normaux des patients pour une identification plus précise des variants somatiques responsables du cancer. Tous les tests de correspondance tumeur + normal qui ont été effectués auparavant sur le test signature xT de Tempus seront désormais traités comme xT CDx, maintenant le flux de commande actuel.
Les cliniciens peuvent améliorer les connaissances moléculaires en combinant le xT CDx avec des tests supplémentaires, notamment le séquençage ARN xR, la biopsie liquide xF/xF+, les tests d'immunohistochimie et les tests algorithmiques pour la déficience de recombinaison homologue et l'évaluation du profil immunitaire.
Tempus AI (NASDAQ: TEM) hat die landesweite Einführung seines FDA-zugelassenen xT CDx-Tests angekündigt, einem umfassenden 648-Gen-Test zur Next-Generation-Sequenzierung für die Profilierung solider Tumore. Der Test umfasst den Status der Mikrosatelliteninstabilität und Begleitdiagnoserechte für Patienten mit kolorektalem Krebs.
Der xT CDx verwendet einen normal angepassten Ansatz, bei dem die parallele DNA-Sequenzierung von solidem Tumorgewebe und normalen Patientensamples durchgeführt wird, um die identifizierung von krebsfördernden somatischen Varianten genauer zu gestalten. Alle bestehenden Tumor + normall Test, die zuvor mit dem charakteristischen xT-Test von Tempus durchgeführt wurden, werden nun als xT CDx verarbeitet und halten den aktuellen Bestellworkflow aufrecht.
Ärzte können molekulare Einsichten erweitern, indem sie xT CDx mit zusätzlichen Tests kombinieren, darunter xR RNA-Sequenzierung, xF/xF+ Flüssigbiopsie, immunhistochemische Tests und algorithmische Tests zur Defizienz in der homologen Rekombination und zur Immunprofilbewertung.
- FDA approval obtained for xT CDx test
- Comprehensive 648-gene panel, one of the largest available
- National market access achieved
- Integration with existing workflow requiring no changes
- Capability to combine with additional diagnostic tests for enhanced insights
- None.
Insights
The national launch of Tempus' FDA-approved xT CDx test represents a major advancement in precision oncology diagnostics. This 648-gene panel is remarkably comprehensive, positioning it among the largest FDA-approved NGS panels available. The test's normal-matched approach, analyzing both tumor and normal tissue DNA, substantially improves the accuracy of identifying cancer-driving mutations.
The test's companion diagnostic capabilities for colorectal cancer and inclusion of microsatellite instability status are particularly valuable for treatment selection. The ability to integrate with additional testing modalities like RNA sequencing, liquid biopsy and algorithmic tests for HRD and immune profiling creates a comprehensive molecular profiling platform.
For investors, this represents significant market potential in the
This FDA approval and national launch significantly strengthens Tempus' market position in the precision medicine space. The comprehensive nature of xT CDx, combined with its FDA approval status, creates substantial revenue opportunities through:
- Higher reimbursement rates for FDA-approved tests compared to laboratory developed tests (LDTs)
- Broader market access through established CPT codes
- Potential for increased market share in the growing precision oncology sector
The seamless integration with existing workflows and additional testing options positions Tempus to capture more revenue per patient through complementary services. For a company with a
The clinical implications of xT CDx are substantial. The 648-gene panel provides unprecedented breadth of molecular information, while the normal-matched approach significantly reduces false positives that can complicate treatment decisions. The companion diagnostic indications streamline the process of matching patients with targeted therapies, particularly in colorectal cancer.
The integration of MSI status testing is important for immunotherapy decisions, while the ability to add HRD and immune profiling provides vital information for both standard and experimental treatment approaches. The test's comprehensive nature means clinicians can obtain multiple clinically relevant results from a single tissue sample, improving efficiency and reducing the need for multiple biopsies.
xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients. xT CDx leverages a normal-matched approach, which is a method of parallel DNA sequencing of a solid tumor and normal patient sample that can lead to more accurate identification of cancer-driving somatic variants. All orders for tumor + normal match tests – traditionally run on the company’s signature xT assay – will now be run as xT CDx with no changes to the current ordering workflow.
"We are thrilled to broadly introduce our xT CDx test, which combines the trusted performance our clinicians rely on, now with FDA approval,” said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. “Tempus has an unwavering commitment to providing high quality and robust assays so clinicians have the most comprehensive and actionable insights in a timely manner. This is consistent with the goal of improving the outcomes for all of their patients, and we look forward to providing xT CDx nationally to make that possible."
Clinicians can enhance molecular insights by adding xR RNA sequencing, xF/xF+ liquid biopsy, immunohistochemistry tests such as HER2 and PD-L1, and algorithmic tests such as homologous recombination deficiency (HRD) and immune profile score (IPS), which promote a streamlined, one-stop experience, supporting patient care. For more information about Tempus’ xT CDx, visit tempus.com.
xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus AI, Inc.,
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 potential impact of xT CDx and other tests 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250115201468/en/
Erin Carron
media@tempus.com
Source: Tempus AI, Inc.
FAQ
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