Tempus Announces the Upcoming Clinical Availability of Its First Whole-Genome Sequencing Assay, xH

Key Terms

whole-genome sequencing medical

Whole-genome sequencing is the process of reading an organism’s entire DNA instruction manual to capture all genetic information rather than just selected parts. For investors, it matters because having the full genetic picture can reveal new diagnostics, drug targets, or personalized treatments that drive product value, regulatory approvals, and long-term revenue potential, while improvements in speed and cost can expand market reach like making a complex map easier and cheaper to produce.

next-generation sequencing medical

Next-generation sequencing is a set of laboratory techniques that read large amounts of DNA or RNA quickly and cheaply by processing millions of short genetic fragments in parallel, rather than one at a time. For investors, it matters because faster, lower-cost genetic data powers drug discovery, diagnostic tests and personalized medicine, creating scalable revenue opportunities and competitive advantages for companies that own the technology or services.

acute myeloid leukemia medical

A fast‑moving blood cancer that starts in the bone marrow and crowd out healthy blood cell production, leaving the body short of normal red cells, white cells and platelets. It matters to investors because the disease creates urgent medical need, drives demand for new diagnostics and treatments, and so clinical trial results, regulatory decisions and drug pricing can rapidly change the commercial prospects and valuation of companies working on therapies.

myelodysplastic syndromes medical

Myelodysplastic syndromes are a group of disorders in which the bone marrow — the body’s blood cell factory — makes blood cells that are abnormal or too few, leading to anemia, infections, or bleeding and sometimes progressing to leukemia. Investors monitor them because demand for effective drugs, clinical trial results, and regulatory approvals can materially affect the revenues and valuations of healthcare companies and influence projected treatment costs and market opportunities.

myeloproliferative neoplasms medical

Myeloproliferative neoplasms are a group of blood cancers caused by the bone marrow producing too many of one or more types of blood cells, which can crowd out normal cells and impair blood flow. Investors pay attention because these conditions create clear medical needs and predictable markets for diagnostics, therapies and follow-up care—similar to a failing factory that creates demand for repair services and replacement parts—affecting drug development, regulatory milestones and potential sales.

positive percent agreement medical

Positive percent agreement (PPA) is the percentage of times a new diagnostic test shows a positive result when a comparator test or reference method also shows a positive result, used when there is no single accepted “gold standard.” For investors, PPA signals how reliably a test identifies positive cases compared with alternatives—like checking how often a new thermometer agrees it’s hot—affecting regulatory acceptance, clinical adoption, and commercial value.

positive predictive value medical

Positive predictive value is a measure of how likely it is that a positive result actually indicates a true positive. For investors, it helps assess how reliable a signal or indicator is in predicting real opportunities or risks, similar to how knowing that a weather forecast predicts rain accurately helps you decide whether to carry an umbrella. A higher positive predictive value means greater confidence that a positive signal truly reflects a meaningful event.

structural variants medical

Structural variants are large-scale changes in an organism’s DNA—such as missing, extra, flipped, or rearranged chunks of genetic material—that are like tearing out, duplicating, or reshuffling chapters in a book. Investors should care because these changes can drive or explain diseases, alter how well diagnostics and therapies work, and shift the commercial and regulatory outlook for drugs, tests, and gene-based treatments.

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CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced the upcoming clinical availability of xH, a next-generation sequencing (NGS) test that uses a whole-genome sequencing (WGS) approach for the detection of actionable oncologic targets in peripheral blood and bone marrow samples from patients with hematologic malignancies.

Tempus first announced the xH assay for research use only in January 2025. The test was developed for use in acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and overlap syndromes (MDS/MPN). It is optimized for myeloid neoplasms and is designed to support disease understanding, biomarker discovery, and therapeutic research.

The performance of the Tempus xH assay was established in an analytical validation study using 235 unique specimens, including whole blood, bone marrow, and cell lines. Assay performance was evaluated by comparison with established orthogonal methods to assess analytical accuracy and precision across multiple variant classes. The analytical validation demonstrated high accuracy across all major alteration types and achieved a positive percent agreement (PPA) of 97.29% for SNVs and Indels against the Tempus xT (DNA; 648 gene) assay, 92.86% PPA for SVs against the Tempus xR (RNA; whole transcriptome sequencing [WTS]) assay and confirmation Sanger sequencing, and 93.43% PPA for CNAs against an Oligo-SNP chromosomal microarray.

In addition to high accuracy, the xH assay demonstrated excellent precision, ensuring reliable and reproducible results. The assay achieved a positive predictive value (PPV) of 98.97% for SNVs (Single Nucleotide Variants) and indels, and 100% for SVs (Structural Variants). These results indicate a low false-positive rate and support high confidence in the assay’s reported genomic findings.

Data presented at the 2026 ASCO Annual meeting demonstrate the assay's clinical utility in resolving historical diagnostic blind spots. In a blinded study of an MDS cohort, xH achieved >99% sensitivity and uncovered 40% more clinically relevant genomic findings, surfacing critical actionable genomic variations that were completely missed by traditional standard of care techniques.

“When we introduced xH, our goal was to create a standardized WGS platform that could transform care in hematologic oncology,” said Tom Schonherr, CEO of Diagnostics, at Tempus. “We’ve realized that vision by replacing multiple time-consuming diagnostic tests with a single, high-throughput whole-genome workflow that helps clinicians make faster, smarter decisions. At the same time, xH provides biopharma partners with a comprehensive multiomic foundation to improve clinical trial design, accelerate biomarker discovery, and support the development of next-generation targeted therapies.”

xH is expected to be commercially available for clinically ordering later this year.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding potential impact of xH, the anticipated timing or development of future clinical availability for xH. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus’ products and services; Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260601323021/en/

Tempus
Hanah Heintzelman
hanah.heintzelman@tempus.com

Source: Tempus AI, Inc.