Tempus AI Receives FDA Approval for Tumor-Only Testing
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Source: NASDAQ.COM
- FDA Approval: Tempus AI announced that its xT CDx next-generation sequencing platform has received FDA approval for a tumor-only indication, making it the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling, highlighting the company's leadership in precision medicine.
- Portfolio Migration: This approval allows Tempus to migrate its entire DNA solid tumor portfolio to FDA-approved assays, which are expected to be priced below the current ADLT pricing, thereby enhancing its competitive position in the market.
- Financial Outlook: CFO Jim Rogers indicated that the approval is anticipated to yield an estimated average selling price benefit of $200 starting in 2027, further strengthening the company's profitability and market appeal.
- Stock Price Reaction: In pre-market trading on Nasdaq, Tempus shares rose by 7.39% to $55.08, reflecting the market's positive response to the new approval and confidence in the company's future growth potential.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy TEM?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on TEM
Wall Street analysts forecast TEM stock price to rise
9 Analyst Rating
4 Buy
5 Hold
0 Sell
Moderate Buy
Current: 51.290
Low
76.00
Averages
84.38
High
105.00
Current: 51.290
Low
76.00
Averages
84.38
High
105.00
About TEM
Tempus AI, Inc. is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. It offers AI-enabled precision medicine solutions to physicians to deliver personalized patient care and, in parallel, facilitates discovery, development and delivery of optimal therapeutics. It provides three product lines: Genomics, Data and artificial intelligence applications (AI). The Genomics product line leverages its laboratories to provide next generation sequencing (NGS) diagnostics, polymerase chain reaction, profiling, molecular genotyping and other anatomic and molecular pathology testing. The data generated in its lab or ingested into its platform is structured and de-identified, prior to commercialization. Its AI Applications is focused on developing and providing diagnostics that are algorithmic in nature, implementing new software as a medical device, and building and deploying clinical decision support tools.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Tempus Launches PRECISION Challenge to Accelerate Oncology Breakthroughs
- Innovative Challenge Program: Tempus has launched the PRECISION Challenge, aimed at accelerating breakthroughs in oncology by providing funding, data, and expertise to multidisciplinary teams worldwide, which is expected to significantly enhance cancer treatment outcomes.
- Resource Support: The program offers participants up to $75,000 in funding and computational resources to support various stages from proof of concept to clinical performance validation, ensuring that funding is closely tied to research progress.
- Data Access: Participants will gain access to Tempus' de-identified data library, one of the world's largest repositories of clinical, molecular, and imaging data, combined with Tempus' foundational models and computational infrastructure to facilitate biological discovery.
- Future Outlook: Tempus plans to open applications in the coming months, encouraging researchers to seize this unprecedented opportunity to address critical issues in oncology and advance precision medicine.
See More
Tempus AI Unveils New AI-Driven Precision Medicine Data
- Stock Surge: Tempus AI (TEM) saw its stock jump over 3% to approximately $53.15 after unveiling new AI-driven precision medicine data at the 2026 ASCO Annual Meeting, indicating strong market enthusiasm for its technological advancements.
- Model Scale: The company's latest multimodal foundation model was trained on 2.5 million longitudinal patient records, including 250 million clinical note pages, 450,000 medical images, and 500,000 genomic and transcriptomic sequences, which is expected to accelerate drug development and improve clinical trial design.
- Clinical Predictive Power: In a study involving EGFR-mutant non-small cell lung cancer patients, the model demonstrated a C-index of 0.802, indicating strong predictive accuracy and significant survival stratification across patient groups, highlighting its potential for early identification of high-risk cancer patients.
- Market Performance: Over the past five days, Tempus AI's stock has climbed approximately 10.68%, significantly outperforming the S&P 500's return of 0.66%, reflecting investor optimism regarding the demand for data-driven precision medicine.
See More
Tempus AI Launches Rapid Clinical Insights Application
- Breakthrough in Precision Medicine: Tempus AI's newly launched Tempus Preview application provides key mutation predictions within approximately 24 hours of tissue receipt, significantly reducing the time between diagnostic test orders and final results, enabling faster treatment decisions during the critical early stages following a cancer diagnosis.
- Focus on High-Impact Biomarkers: The application targets early insights into high-impact biomarkers such as microsatellite instability (MSI-H) and EGFR mutations, enhancing predictions for responses to immune checkpoint inhibitors and targeted therapies, thereby improving patient prognosis.
- AI-Driven Precision Analysis: Powered by the Paige Predict model, Tempus Preview analyzes standard H&E images to deliver genomic insights, having been validated for clinical use after training on millions of slides, which further strengthens Tempus's competitive edge in the precision medicine sector.
- Strategic Data Integration: By combining its unique diagnostic lab with an advanced data platform, Tempus creates powerful AI models that deliver early, clinically relevant information directly into clinical workflows, assisting physicians in making more informed decisions in patient treatment.
See More
Tempus AI Unveils Latest Results on Multimodal Foundation Models
- Data-Driven Precision Medicine: Tempus AI leverages over 500 petabytes of molecular data and 1.5 million sequenced records to build multimodal foundation models, significantly enhancing the efficiency of clinical trial design and patient risk prediction, thereby accelerating the application of precision medicine.
- Model Performance Validation: When analyzing EGFR-mutant NSCLC patients, the model achieved a C-index of 0.802, indicating high accuracy in survival predictions, with a hazard ratio of 4.536 between high- and low-risk subgroups, demonstrating significant survival stratification capabilities.
- Clinical Trial Potential: Tempus' multimodal patient trajectory model outperformed traditional Cox-PH modeling in cohorts mirroring clinical trials, indicating substantial utility in drug development by assessing features that may impact clinical trial performance before trials commence.
- Strategic Vision: Founder Eric Lefkofsky emphasized that the combination of foundation models and agentic workflows will expedite hypothesis testing and compress the timeline from discovery to clinical application, driving the development of new diagnostics and novel medicines, further solidifying the company's leadership in precision medicine.
See More
Tempus AI Receives FDA Approval for Tumor-Only Testing
- FDA Approval: Tempus AI announced that its xT CDx next-generation sequencing platform has received FDA approval for a tumor-only indication, making it the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling, highlighting the company's leadership in precision medicine.
- Portfolio Migration: This approval allows Tempus to migrate its entire DNA solid tumor portfolio to FDA-approved assays, which are expected to be priced below the current ADLT pricing, thereby enhancing its competitive position in the market.
- Financial Outlook: CFO Jim Rogers indicated that the approval is anticipated to yield an estimated average selling price benefit of $200 starting in 2027, further strengthening the company's profitability and market appeal.
- Stock Price Reaction: In pre-market trading on Nasdaq, Tempus shares rose by 7.39% to $55.08, reflecting the market's positive response to the new approval and confidence in the company's future growth potential.
See More
Tempus AI Receives FDA Approval for Tumor-Only Testing
- FDA Approval Milestone: Tempus AI's xT CDx platform has received FDA approval for a tumor-only indication, making it the first laboratory to hold both tumor-only and tumor-normal comprehensive genomic profiling, marking a significant advancement in the precision medicine field.
- Market Potential Unlocked: This approval allows xT CDx to be performed without a matched normal sample, with an expected average selling price (ASP) benefit of $200 per test starting in 2027, significantly enhancing revenue potential for the company.
- Increased Technical Flexibility: As a companion diagnostic tool, xT CDx can identify colorectal cancer patients who may benefit from targeted therapies like Erbitux® and Vectibix®, providing a broader range of clinical applications to meet diverse patient needs.
- Strategic Integration Advantage: This approval facilitates the migration of Tempus's entire solid tumor DNA portfolio to FDA-approved assays under a unified pricing strategy, further strengthening the company's competitive edge and market share in the precision medicine sector.
See More
Tempus Launches PRECISION Challenge to Accelerate Oncology Breakthroughs
- Innovative Challenge Program: Tempus has launched the PRECISION Challenge, aimed at accelerating breakthroughs in oncology by providing funding, data, and expertise to multidisciplinary teams worldwide, which is expected to significantly enhance cancer treatment outcomes.
- Resource Support: The program offers participants up to $75,000 in funding and computational resources to support various stages from proof of concept to clinical performance validation, ensuring that funding is closely tied to research progress.
- Data Access: Participants will gain access to Tempus' de-identified data library, one of the world's largest repositories of clinical, molecular, and imaging data, combined with Tempus' foundational models and computational infrastructure to facilitate biological discovery.
- Future Outlook: Tempus plans to open applications in the coming months, encouraging researchers to seize this unprecedented opportunity to address critical issues in oncology and advance precision medicine.
See More
Tempus AI Unveils New AI-Driven Precision Medicine Data
- Stock Surge: Tempus AI (TEM) saw its stock jump over 3% to approximately $53.15 after unveiling new AI-driven precision medicine data at the 2026 ASCO Annual Meeting, indicating strong market enthusiasm for its technological advancements.
- Model Scale: The company's latest multimodal foundation model was trained on 2.5 million longitudinal patient records, including 250 million clinical note pages, 450,000 medical images, and 500,000 genomic and transcriptomic sequences, which is expected to accelerate drug development and improve clinical trial design.
- Clinical Predictive Power: In a study involving EGFR-mutant non-small cell lung cancer patients, the model demonstrated a C-index of 0.802, indicating strong predictive accuracy and significant survival stratification across patient groups, highlighting its potential for early identification of high-risk cancer patients.
- Market Performance: Over the past five days, Tempus AI's stock has climbed approximately 10.68%, significantly outperforming the S&P 500's return of 0.66%, reflecting investor optimism regarding the demand for data-driven precision medicine.
See More
Tempus AI Launches Rapid Clinical Insights Application
- Breakthrough in Precision Medicine: Tempus AI's newly launched Tempus Preview application provides key mutation predictions within approximately 24 hours of tissue receipt, significantly reducing the time between diagnostic test orders and final results, enabling faster treatment decisions during the critical early stages following a cancer diagnosis.
- Focus on High-Impact Biomarkers: The application targets early insights into high-impact biomarkers such as microsatellite instability (MSI-H) and EGFR mutations, enhancing predictions for responses to immune checkpoint inhibitors and targeted therapies, thereby improving patient prognosis.
- AI-Driven Precision Analysis: Powered by the Paige Predict model, Tempus Preview analyzes standard H&E images to deliver genomic insights, having been validated for clinical use after training on millions of slides, which further strengthens Tempus's competitive edge in the precision medicine sector.
- Strategic Data Integration: By combining its unique diagnostic lab with an advanced data platform, Tempus creates powerful AI models that deliver early, clinically relevant information directly into clinical workflows, assisting physicians in making more informed decisions in patient treatment.
See More
Tempus AI Unveils Latest Results on Multimodal Foundation Models
- Data-Driven Precision Medicine: Tempus AI leverages over 500 petabytes of molecular data and 1.5 million sequenced records to build multimodal foundation models, significantly enhancing the efficiency of clinical trial design and patient risk prediction, thereby accelerating the application of precision medicine.
- Model Performance Validation: When analyzing EGFR-mutant NSCLC patients, the model achieved a C-index of 0.802, indicating high accuracy in survival predictions, with a hazard ratio of 4.536 between high- and low-risk subgroups, demonstrating significant survival stratification capabilities.
- Clinical Trial Potential: Tempus' multimodal patient trajectory model outperformed traditional Cox-PH modeling in cohorts mirroring clinical trials, indicating substantial utility in drug development by assessing features that may impact clinical trial performance before trials commence.
- Strategic Vision: Founder Eric Lefkofsky emphasized that the combination of foundation models and agentic workflows will expedite hypothesis testing and compress the timeline from discovery to clinical application, driving the development of new diagnostics and novel medicines, further solidifying the company's leadership in precision medicine.
See More
Tempus AI Receives FDA Approval for Tumor-Only Testing
- FDA Approval: Tempus AI announced that its xT CDx next-generation sequencing platform has received FDA approval for a tumor-only indication, making it the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling, highlighting the company's leadership in precision medicine.
- Portfolio Migration: This approval allows Tempus to migrate its entire DNA solid tumor portfolio to FDA-approved assays, which are expected to be priced below the current ADLT pricing, thereby enhancing its competitive position in the market.
- Financial Outlook: CFO Jim Rogers indicated that the approval is anticipated to yield an estimated average selling price benefit of $200 starting in 2027, further strengthening the company's profitability and market appeal.
- Stock Price Reaction: In pre-market trading on Nasdaq, Tempus shares rose by 7.39% to $55.08, reflecting the market's positive response to the new approval and confidence in the company's future growth potential.
See More
Tempus AI Receives FDA Approval for Tumor-Only Testing
- FDA Approval Milestone: Tempus AI's xT CDx platform has received FDA approval for a tumor-only indication, making it the first laboratory to hold both tumor-only and tumor-normal comprehensive genomic profiling, marking a significant advancement in the precision medicine field.
- Market Potential Unlocked: This approval allows xT CDx to be performed without a matched normal sample, with an expected average selling price (ASP) benefit of $200 per test starting in 2027, significantly enhancing revenue potential for the company.
- Increased Technical Flexibility: As a companion diagnostic tool, xT CDx can identify colorectal cancer patients who may benefit from targeted therapies like Erbitux® and Vectibix®, providing a broader range of clinical applications to meet diverse patient needs.
- Strategic Integration Advantage: This approval facilitates the migration of Tempus's entire solid tumor DNA portfolio to FDA-approved assays under a unified pricing strategy, further strengthening the company's competitive edge and market share in the precision medicine sector.
See More
