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Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD
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Key Takeaways
Tempus AI gained FDA clearance for its RNA sequencing-based xR IVD device.
TEM's xR IVD detects gene rearrangements in tumor tissues from solid malignancies.
The device bolsters Tempus AI's role in oncology research and drug development.
RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and development, RNA analysis helps identify molecular pathways and networks directly involved in disease progression.
Tempus AI (TEM - Free Report) is leveraging this technology to advance therapeutic development through its Tempus xR IVD device, unlocking the full potential of RNA-based insights. Yesterday, the company received 510(k) clearance from the Food and Drug Administration (“FDA”) for its xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.
The Tempus xR IVD assay is a qualitative, next-generation sequencing–based in vitro diagnostic device that uses targeted, high-throughput, hybridization-based capture technology to detect rearrangements in two genes. It analyzes RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.
The xR IVD device is one of several innovative solutions used by Tempus to drive advancements in oncology therapeutic research and development. Its FDA authorization reinforces Tempus’ position as a comprehensive, one-stop provider of precision medicine solutions.
Peer Update
An expanding NGS oncology portfolio is helping Illumina (ILMN - Free Report) drive the revolution in cancer genomics. The company’s market-leading TruSight Oncology assay, TSO 500, continues to see increased utilization and broader adoption. This year, Illumina is set to roll out TSO 500 v2, a new version that includes hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay from one sample, to facilitate therapy selection research. Following FDA approval last year, Illumina's in vitro diagnostic (IVD) TSO Comprehensive test has gained broad payer reimbursement, expanding access to comprehensive genomic profiling and enabling matching of patients with targeted therapies.
QIAGEN (QGEN - Free Report) sees significant opportunities for NGS to deliver on the vision of precision medicine. QIAGEN Digital Insights (“QDI”) business is extending its leadership by unlocking complex genomics data with greater speed and accuracy for clinical and research customers. The integration of AI into the QDI portfolio is another positive development. Recently, the company launched new QIAseq panels for use on next-generation sequencers, designed to enhance the analysis of over 700 genes for comprehensive genomic profiling in research and clinical applications. Additionally, the QIAseq xHYB CGP portfolio is being expanded to offer a highly curated solution for multimodal cancer genomic profiling.
TEM Stock Outperforms Industry & Benchmark
In the past year, Tempus AI shares have rallied 55.1%, outperforming the industry’s 22.7% growth and the S&P 500 composite’s 18.7% improvement.
Image Source: Zacks Investment Research
Expensive Valuation
TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 10.16X compared with the industry average of 5.59X.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
In the past 30 days, Tempus AI's loss per share estimate for 2025 has moved south 1 cent.
Image: Bigstock
Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD
Key Takeaways
RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and development, RNA analysis helps identify molecular pathways and networks directly involved in disease progression.
Tempus AI (TEM - Free Report) is leveraging this technology to advance therapeutic development through its Tempus xR IVD device, unlocking the full potential of RNA-based insights. Yesterday, the company received 510(k) clearance from the Food and Drug Administration (“FDA”) for its xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.
The Tempus xR IVD assay is a qualitative, next-generation sequencing–based in vitro diagnostic device that uses targeted, high-throughput, hybridization-based capture technology to detect rearrangements in two genes. It analyzes RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.
The xR IVD device is one of several innovative solutions used by Tempus to drive advancements in oncology therapeutic research and development. Its FDA authorization reinforces Tempus’ position as a comprehensive, one-stop provider of precision medicine solutions.
Peer Update
An expanding NGS oncology portfolio is helping Illumina (ILMN - Free Report) drive the revolution in cancer genomics. The company’s market-leading TruSight Oncology assay, TSO 500, continues to see increased utilization and broader adoption. This year, Illumina is set to roll out TSO 500 v2, a new version that includes hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay from one sample, to facilitate therapy selection research. Following FDA approval last year, Illumina's in vitro diagnostic (IVD) TSO Comprehensive test has gained broad payer reimbursement, expanding access to comprehensive genomic profiling and enabling matching of patients with targeted therapies.
QIAGEN (QGEN - Free Report) sees significant opportunities for NGS to deliver on the vision of precision medicine. QIAGEN Digital Insights (“QDI”) business is extending its leadership by unlocking complex genomics data with greater speed and accuracy for clinical and research customers. The integration of AI into the QDI portfolio is another positive development. Recently, the company launched new QIAseq panels for use on next-generation sequencers, designed to enhance the analysis of over 700 genes for comprehensive genomic profiling in research and clinical applications. Additionally, the QIAseq xHYB CGP portfolio is being expanded to offer a highly curated solution for multimodal cancer genomic profiling.
TEM Stock Outperforms Industry & Benchmark
In the past year, Tempus AI shares have rallied 55.1%, outperforming the industry’s 22.7% growth and the S&P 500 composite’s 18.7% improvement.
Image Source: Zacks Investment Research
Expensive Valuation
TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 10.16X compared with the industry average of 5.59X.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
In the past 30 days, Tempus AI's loss per share estimate for 2025 has moved south 1 cent.
Image Source: Zacks Investment Research
TEM stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.