Tempus AI, Inc. - TEM STOCK NEWS

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) has unveiled new generative AI capabilities for its Tempus One platform, enhancing its ability to analyze unstructured healthcare data. The platform now features four key innovations: Patient Query for improved clinical trial matching, Patient Timeline for comprehensive patient journey visualization, Prior Authorization to streamline administrative processes, and Data Exploration for advanced research capabilities.

These new features leverage Tempus' proprietary Large Language Model (LLM) Agent Infrastructure to process millions of unstructured documents, including progress notes, pathology reports, and imaging scans. The system can now create structured timelines of clinical events, facilitate patient enrollment in clinical trials, assist with prior authorization documentation, and enable researchers to analyze de-identified datasets more efficiently.

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) released preliminary, unaudited results for Q4 and full year 2024. The company reported approximate full-year revenue of $693 million, showing ~30% year-over-year growth, and Q4 revenue of $200 million, representing ~35% year-over-year growth.

The company's genomics revenue is expected to grow ~30% in Q4, while data and services revenue is projected to grow ~45%. Tempus expects to achieve ~99% of its 2024 revenue guidance and ~100% of adjusted EBITDA guidance, despite noting some softness in CRO revenues. Both Q4 and full-year results showed continued improvement in adjusted EBITDA compared to previous periods.

These preliminary results are subject to change pending completion of year-end close and review procedures. Final detailed financial results will be reported during the company's first earnings call of 2025.

Tempus (NASDAQ: TEM) announced a multi-year collaboration with Genialis to develop RNA-based biomarker algorithms for cancer treatment. Genialis will utilize Tempus' multimodal dataset to validate and enhance their AI foundation model, which uses data from approximately 1 million RNA-sequencing samples.

Through this partnership, Genialis gains access to Tempus' analytics platform, Lens, providing development tools and de-identified patient records. In return, Tempus receives rights to evaluate and potentially license Genialis-developed algorithms for commercialization within their xR platform.

The collaboration has already contributed to the launch of Genialis™krasID, the first commercial algorithm predicting patient response to KRAS-targeted therapies across cancer types. This algorithm, validated using Tempus' real-world data, effectively stratifies patients into response likelihood groups.

Tempus AI (NASDAQ: TEM) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 13-16, 2025, in San Francisco. The company's involvement includes two key events:

1. A presentation and Q&A session with investors led by Founder and CEO Eric Lefkofsky on Monday, January 13

2. A panel discussion on Policy Outlook for Artificial Intelligence in Healthcare & Diagnostics featuring Chief Scientific Officer Kate Sasser on Wednesday, January 15

The company will provide a live webcast option for accessing the January 13 presentation. Tempus AI specializes in leveraging artificial intelligence to enhance precision medicine and improve patient care outcomes.

Tempus has secured in-network provider status with several major healthcare insurers, including Blue Cross Blue Shield (BCBS) of Illinois, Blue Shield of California, and Avalon Healthcare Solutions. Through the Avalon agreement, Tempus becomes a participating provider with BCBS entities in North Carolina, South Carolina, Vermont, as well as Capital BlueCross and CareSource in four markets. This expansion enhances Tempus' presence with commercial health plans in the East.

The agreements enable patients with these insurance plans to access Tempus' comprehensive molecular profiling portfolio as a participating provider, potentially leading to lower out-of-pocket costs for testing services. These molecular profiling tests help physicians make more informed, personalized treatment decisions throughout patients' care journeys.

Tempus AI (NASDAQ: TEM) announces a significant Medicare coverage decision for its ECG-AF device. The Centers for Medicare and Medicaid Services (CMS) will provide reimbursement for cardiac dysfunction assessments using the Tempus ECG-AF algorithm, with a Medicare rate of $128.90 effective January 1, 2025.

The FDA-cleared device analyzes 12-lead ECG recordings to detect signs of atrial fibrillation (AF) risk within 12 months for patients 65 and older. This development follows Tempus' earlier FDA 510(k) clearance, marking the first AF indication in cardiovascular machine learning-based notification software. With nearly one million Americans having undetected AF and over 100 million ECGs performed annually in the U.S., this AI-powered solution aims to enhance early disease detection.

Personalis (Nasdaq: PSNL) and Tempus AI (Nasdaq: TEM) have expanded their commercial relationship to benefit the biopharma industry. Originally agreed upon in November 2023, the collaboration aims to bring ultra-sensitive MRD testing to market. The partnership was launched at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, with Tempus serving as the exclusive commercial diagnostic partner for Personalis' NeXT Personal® Dx. This product is designed for broad patient adoption in breast and lung cancers and immunotherapy monitoring across all solid tumors.

Following a positive market reaction, Tempus will now offer Personalis' NeXT Personal MRD product to pharmaceutical and biotech customers. These customers can bundle MRD testing with other Tempus offerings within a given study. Chris Hall, CEO of Personalis, believes that this expansion will accelerate market penetration and capitalize on new opportunities.