NPJ Precision Oncology Publishes Tempus Study on Validation of its HLA-LOH Investigational Assay
Tempus AI (NASDAQ: TEM) announced the publication of a validation study for its human leukocyte antigen (HLA) loss of heterozygosity (LOH) investigational assay in npj Precision Oncology. The study validates an investigational test that detects HLA-LOH using data from Tempus' FDA-approved xT CDx assay. The test employs a machine learning model to identify solid tumor patients with allele-specific LOH for specific HLA Class I alleles, potentially benefiting from targeted therapies.
The study demonstrated the test's accuracy in detecting HLA-LOH in clinical samples with ≥40% tumor cells. Collaborating with A2 Biotherapeutics, Tempus analyzed data from an observational clinical trial (NCT04981119), showing the feasibility of identifying and accruing HLA-LOH patients for prospective studies. In 2023, the FDA granted Breakthrough Device Designation for the HLA-LOH assay as a companion diagnostic test, although it's currently not available for clinical use.
Tempus AI (NASDAQ: TEM) ha annunciato la pubblicazione di uno studio di convalida per il suo test investigativo sulla perdita di eterozigosi (LOH) dell'antigene leucocitario umano (HLA) nella rivista npj Precision Oncology. Lo studio convalida un test investigativo che rileva la HLA-LOH utilizzando i dati del test xT CDx approvato dalla FDA di Tempus. Il test utilizza un modello di machine learning per identificare pazienti con tumori solidi che presentano LOH specifico per allele per specifici alleli HLA di Classe I, beneficiando potenzialmente di terapie mirate.
Lo studio ha dimostrato l'accuratezza del test nel rilevare la HLA-LOH in campioni clinici con ≥40% di cellule tumorali. Collaborando con A2 Biotherapeutics, Tempus ha analizzato i dati di uno studio clinico osservazionale (NCT04981119), dimostrando la fattibilità di identificare e reclutare pazienti con HLA-LOH per studi prospettici. Nel 2023, la FDA ha concesso la Designazione di Dispositivo Innovativo per il test HLA-LOH come test diagnostico companion, anche se attualmente non è disponibile per l'uso clinico.
Tempus AI (NASDAQ: TEM) anunció la publicación de un estudio de validación para su ensayo de investigación sobre la pérdida de heterocigosidad (LOH) del antígeno leucocitario humano (HLA) en npj Precision Oncology. El estudio valida una prueba experimental que detecta la HLA-LOH utilizando datos del ensayo xT CDx aprobado por la FDA de Tempus. La prueba utiliza un modelo de aprendizaje automático para identificar a pacientes con tumores sólidos que tienen LOH específico para alelos de HLA de Clase I, lo que podría beneficiarles con terapias dirigidas.
El estudio demostró la precisión de la prueba para detectar la HLA-LOH en muestras clínicas con ≥40% de células tumorales. Colaborando con A2 Biotherapeutics, Tempus analizó datos de un ensayo clínico observacional (NCT04981119), mostrando la viabilidad de identificar y reclutar pacientes con HLA-LOH para los estudios prospectivos. En 2023, la FDA otorgó la Designación de Dispositivo Innovador para el ensayo HLA-LOH como prueba diagnóstica complementaria, aunque actualmente no está disponible para uso clínico.
템퍼스 AI (NASDAQ: TEM)는 npj Precision Oncology에 대한 인간 백혈구 항원(HLA) 이형접합성 손실(LOH) 실험적 검사의 검증 연구 발표를 알렸습니다. 이 연구는 Tempus의 FDA 승인 xT CDx 검사에서 수집한 데이터를 사용하여 HLA-LOH를 감지하는 실험적 테스트를 검증합니다. 이 테스트는 기계 학습 모델을 사용하여 특정 HLA 클래스 I 대립 유전자에 대한 대립 특이적 LOH가 있는 고형 종양 환자를 식별하며, 이는 표적 치료의 혜택을 받을 수 있습니다.
이 연구는 종양 세포가 ≥40%인 임상 샘플에서 HLA-LOH를 탐지하는 테스트의 정확성을 입증했습니다. A2 Biotherapeutics와 협력하여 Tempus는 관찰 임상 시험(NCT04981119) 데이터를 분석하여 HLA-LOH 환자를 주도적인 연구를 위해 식별하고 모집하는 가능성을 나타냈습니다. 2023년 FDA는 HLA-LOH 검사를 동반 진단 테스트로 혁신 장치 지정을 부여했지만, 현재는 임상적 사용이 불가능합니다.
Tempus AI (NASDAQ: TEM) a annoncé la publication d'une étude de validation pour son assai expérimental de perte d'hétérozygotie (LOH) de l'antigène leucocytaire humain (HLA) dans npj Precision Oncology. L'étude valide un test expérimental qui détecte la HLA-LOH à partir des données de l'essai xT CDx approuvé par la FDA de Tempus. Le test utilise un modèle d'apprentissage automatique pour identifier les patients atteints de tumeurs solides présentant une LOH spécifique à l'allèle pour des allèles HLA de classe I spécifiques, pouvant bénéficier de thérapies ciblées.
L'étude a démontré l'exactitude du test pour détecter la HLA-LOH dans des échantillons cliniques avec ≥40 % de cellules tumorales. En collaboration avec A2 Biotherapeutics, Tempus a analysé des données provenant d'un essai clinique observationnel (NCT04981119), montrant la faisabilité d'identifier et de recruter des patients HLA-LOH pour des études prospectives. En 2023, la FDA a accordé la désignation de dispositif de percée pour l'assai HLA-LOH en tant que test diagnostique compagnon, bien qu'il ne soit actuellement pas disponible pour une utilisation clinique.
Tempus AI (NASDAQ: TEM) gab die Veröffentlichung einer Validierungsstudie für sein experimentelles Verfahren zur Verlust der Heterozygotie (LOH) des menschlichen Leukozytenantigens (HLA) in npj Precision Oncology bekannt. Die Studie validiert einen experimentellen Test, der HLA-LOH mithilfe von Daten aus dem von der FDA zugelassenen xT CDx-Test von Tempus erkennt. Der Test verwendet ein Machine-Learning-Modell, um Patienten mit soliden Tumoren zu identifizieren, die allele-spezifische LOH für bestimmte HLA-Klasse-I-Alelo haben und möglicherweise von gezielten Therapien profitieren können.
Die Studie zeigte die Genauigkeit des Tests bei der Erkennung von HLA-LOH in klinischen Proben mit ≥40% Tumorzellen. In Zusammenarbeit mit A2 Biotherapeutics analysierte Tempus Daten aus einer beobachtenden klinischen Studie (NCT04981119), die die Machbarkeit der Identifizierung und Rekrutierung von HLA-LOH-Patienten für prospektive Studien zeigt. Im Jahr 2023 verlieh die FDA dem HLA-LOH-Test die Breakthrough Device Designation als begleitenden diagnostischen Test, obwohl dieser derzeit nicht für den klinischen Gebrauch verfügbar ist.
- Publication of validation study in npj Precision Oncology
- Successful analytical validation of HLA-LOH investigational assay
- Potential to identify patients for targeted therapies
- FDA Breakthrough Device Designation granted in 2023
- HLA-LOH assay is not yet available for clinical use
Insights
The publication of Tempus' HLA-LOH investigational assay validation study in npj Precision Oncology is a significant milestone for precision oncology. This assay, which detects Human Leukocyte Antigen Loss of Heterozygosity (HLA-LOH), could be a game-changer in identifying patients who may benefit from targeted therapies, particularly in solid tumors.
The study's results are promising, demonstrating the assay's ability to accurately detect HLA-LOH in clinical samples with
However, it's important to note that the assay is still investigational and not yet available for clinical use. Further studies and regulatory approvals will be necessary before it can be widely implemented in patient care.
The development of Tempus' HLA-LOH assay represents a significant advancement in precision oncology. By leveraging machine learning to analyze data from the FDA-approved xT CDx assay, this test could potentially streamline the diagnostic process and improve treatment selection for cancer patients.
The ability to detect allele-specific LOH for HLA Class I alleles is particularly exciting. This could help identify patients who are more likely to respond to specific targeted therapies, especially in the realm of cell therapies for solid tumors. The potential to use this assay alongside other established biomarkers could further refine our approach to personalized cancer treatment.
However, as an oncologist, I caution that while promising, this technology is still in its early stages. We need to see more extensive clinical trials and real-world data to fully understand its impact on patient outcomes and its place in the clinical workflow.
The publication of this study and the FDA's Breakthrough Device Designation for Tempus' HLA-LOH assay are positive indicators for the company's future market position. This technology could potentially give Tempus a competitive edge in the rapidly growing precision oncology market.
If successfully commercialized, this assay could become a valuable companion diagnostic for pharmaceutical companies developing targeted cancer therapies, particularly in the emerging field of cell therapies for solid tumors. This could lead to new partnership opportunities and revenue streams for Tempus.
However, investors should be aware that the path from investigational device to clinical implementation can be long and uncertain. The success of this assay will depend on further validation studies, regulatory approvals and adoption by oncologists and pharmaceutical companies. While promising, it's important to view this development as part of Tempus' long-term growth strategy rather than an immediate revenue driver.
The study evaluated the test’s ability to accurately detect HLA-LOH in clinical samples with >=
“Tempus’ HLA-LOH test is particularly significant for use in clinical trials that apply cell therapy to solid tumors, and it also has wider implications for precision medicine, including its use alongside other established biomarkers,” said Kate Sasser, PhD, Chief Scientific Officer at Tempus. “As validated in this study, the HLA-LOH test may help identify patients most likely to benefit from new and exciting therapies.”
In 2023, the
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.
About xT CDx
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.,
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 quality of this study; the contributions of this study to the larger scientific community, and the use of Tempus’ products and services to advance clinical care for patients. 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 June 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 Carron
media@tempus.com
Source: Tempus AI, Inc.
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