Tempus AI stock soars 14% after FDA approval of xT CDx test

Tempus AI, a leader in healthcare technology, has unveiled its FDA-approved in vitro diagnostic device, xT CDx, marking a pivotal step forward in precision oncology. The company’s announcement sent its stock soaring by 14%, reaching $36.42. With this breakthrough, Tempus is redefining how clinicians approach cancer diagnostics and treatment, offering new hope to patients nationwide.

xT CDx is a next-generation sequencing (NGS) test designed for solid tumor profiling. It stands out with its expansive 648-gene panel, which includes microsatellite instability (MSI) status and companion diagnostic claims for colorectal cancer patients. By making xT CDx accessible to all ordering clinicians in the United States, Tempus underscores its commitment to improving clinical outcomes through advanced technology.

What Is xT CDx, and Why Does It Matter?

Tempus AI’s xT CDx is a revolutionary diagnostic tool tailored for patients with solid malignant neoplasms. Unlike conventional tests, xT CDx employs a “normal-matched approach,” a method that sequences DNA from both tumor tissue and a normal patient sample, such as blood or saliva. This parallel sequencing enhances the accuracy of identifying somatic variants, which are critical in determining the genetic drivers of cancer.

The xT CDx test enables clinicians to uncover detailed genomic insights, which support personalised treatment plans. For colorectal cancer patients, it offers the ability to identify candidates for targeted therapies listed in the FDA’s Companion Diagnostic Indications table. By integrating these capabilities into a single platform, Tempus ensures that clinicians have access to comprehensive, actionable data without altering the existing workflow.

Broader Applications of xT CDx

Tempus AI has built xT CDx to provide unparalleled flexibility and depth in genomic analysis. While its primary focus is solid tumor profiling, the test also integrates seamlessly with additional diagnostic tools offered by Tempus. Clinicians can enhance their molecular analysis with supplementary services such as:

RNA sequencing through the xR platform.

Liquid biopsy options, including xF and xF+.

Immunohistochemistry tests for markers like HER2 and PD-L1.

Algorithmic insights, including homologous recombination deficiency (HRD) and immune profile score (IPS).

This combination delivers a streamlined diagnostic process, ensuring clinicians can gather a wealth of molecular information in a single, efficient workflow.

Expert Insights on the Launch

Dr. Ezra Cohen, Chief Medical Officer of Oncology at Tempus, noted the significance of FDA approval for xT CDx. He stated that this milestone reflects the company’s dedication to providing high-quality, reliable tools for clinicians. By enhancing molecular insights, Tempus aims to empower healthcare providers with data that drives better outcomes for their patients.

Dr. Cohen further explained that the xT CDx’s normal-matched approach improves the identification of cancer-driving mutations, ensuring more accurate and effective treatment plans. He emphasised that this aligns with Tempus’ broader mission of advancing precision medicine through the intelligent application of artificial intelligence and genomics.

Tempus AI: Pioneering Precision Medicine

Tempus AI’s xT CDx launch is part of the company’s larger vision to transform the healthcare landscape. By combining one of the world’s most extensive libraries of multimodal data with cutting-edge AI tools, Tempus provides clinicians with a powerful platform to deliver personalised patient care.

The company’s approach is rooted in the principle that every patient should benefit from the insights of those who came before. As new data is continuously added to its platform, Tempus ensures that its diagnostic tools evolve to remain at the forefront of medical innovation.

What Sets Tempus AI Apart?

Unlike traditional diagnostic companies, Tempus AI integrates data-driven insights into every aspect of its operations. The company’s proprietary operating system leverages machine learning to provide clinicians with real-time, actionable information. This includes identifying emerging treatment trends, assessing patient eligibility for clinical trials, and tailoring therapies to individual genomic profiles.

The xT CDx test exemplifies this ethos by combining state-of-the-art NGS technology with Tempus’ AI capabilities. As a result, clinicians can not only diagnose cancer with greater accuracy but also optimise treatment strategies for improved patient outcomes.

A Step Forward in Oncology Diagnostics

The introduction of xT CDx signifies more than just a product launch—it marks a shift in how cancer care is delivered. By providing clinicians with tools that offer both depth and precision, Tempus AI is helping to close the gap between diagnosis and treatment.

Patients with solid tumors, particularly those with colorectal cancer, now have access to a diagnostic solution that ensures they receive the most effective, personalised care. Moreover, the integration of additional diagnostic capabilities within the xT CDx platform creates a seamless experience for clinicians, reducing complexity and enhancing efficiency.

Looking Ahead

With the national rollout of xT CDx, Tempus AI is well-positioned to lead the next wave of innovation in precision medicine. As the company continues to expand its portfolio of AI-driven healthcare solutions, it remains committed to its mission of improving patient outcomes through technology and data.

The FDA approval of xT CDx not only validates Tempus’ approach but also sets a new benchmark for the industry. By bridging the gap between data and care, Tempus AI is paving the way for a future where every cancer patient can benefit from personalised, data-driven treatment strategies.