Tempus AI, Inc. - TEM STOCK NEWS

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.

Healthcare executives are increasingly adopting generative AI, with 90% reporting positive ROI from their investments. The Global AI in Healthcare Market is projected to reach $164.16 billion by 2030, growing at a 49.1% CAGR. In a significant development, Avant Technologies has partnered with Roche and Salud 360 to launch a pilot program in Costa Rica targeting diabetic retinopathy using AI technology. The program utilizes non-mydriatic fundus cameras and AI to analyze retinal images for early detection of the condition. Initially implemented in Costa Rica, where diabetes affects 10.4% of adults, the program aims to expand to the US, Canada, and Europe if successful.

Tempus AI (NASDAQ: TEM), a leader in AI-driven precision medicine and healthcare technology, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The event will take place in New York on December 3, 2024. Tempus Founder and CEO Eric Lefkofsky is scheduled to engage in a fireside discussion at 3:00 p.m. ET during the conference.

Tempus announced a collaboration with Flatiron Health to integrate its genomic testing capabilities into Flatiron's OncoEMR® platform through Molecular Profiling Integration (MPI). This integration will provide 4,200 providers across 800 community-based cancer care locations with direct access to Tempus' suite of testing options within their workflow. The system enables electronic ordering, tracking, and result delivery through a unified ordering system, reducing administrative burden. The integration includes access to various Tempus tests including xT, xR, xF/xF+, xG/xG+ Ambry, and xM/xM, along with AI-enabled algorithmic add-on tests.

Tempus has published a study in JAMA Network Open demonstrating the advantages of combining RNA and DNA sequencing in advanced non-small cell lung cancer (NSCLC) treatment. The retrospective study of over 5,500 NSCLC patients revealed that concurrent RNA- and DNA-based next-generation sequencing detected more actionable structural variants than DNA sequencing alone. 8.8% of patients showed at least one actionable variant, with the combined approach increasing variant detection by 15.3% and more than doubling the identification of rare structural variants compared to DNA sequencing alone.

Tempus AI (NASDAQ: TEM) announced nine abstracts accepted for presentation at the Society for Immunotherapy of Cancer's 39th Annual Meeting in November 2024. Key highlights include two poster presentations: one validating a novel multi-omic algorithm for predicting immune checkpoint inhibitor (ICI) treatment outcomes using the Immune Profile Score (IPS), and another analyzing the cost-effectiveness of molecular biomarkers combined with CT imaging for treatment response monitoring. The second study, involving 4,147 cancer patients, demonstrated significant cost savings when using molecular biomarkers alongside CT imaging, particularly in small cell lung cancer treated with ICI-chemotherapy.

Tempus announced the clinical launch of its Immune Profile Score (IPS) algorithmic test, a multimodal biomarker for adult patients with stage IV and metastatic pan-solid tumors who are candidates for immune checkpoint inhibitor therapy. The validation study, involving 1,600 patients with 19 different solid tumor types, showed that IPS-High patients were more likely to have better overall survival while receiving ICI-based therapy compared to IPS-Low patients (HR 0.45). The test calculates a score from 0-100 and provides IPS-Low or IPS-High classification, operating independently of tumor mutational burden, PD-L1 immunohistochemistry, and microsatellite instability status.

Tempus reported Q3 2024 financial results and announced the acquisition of Ambry Genetics for $600M ($375M cash, $225M shares). Revenue grew 33% YoY to $180.9M, with data services revenue up 64.4% and genomics unit growth of 23.9%. The company posted a net loss of $(75.8M), including $22.2M in stock compensation. Ambry Genetics is expected to generate >$300M revenue and >$40M EBITDA in 2024. The acquisition expands Tempus' testing capabilities in hereditary cancer screening and new disease categories. Full-year 2024 guidance maintains at ~$700M revenue.