Tempus xR RNA Sequencing Assay Receives EU IVDR Class C Certification

Tempus AI (TEM ) said in an October 26, 2026 announcement that its xR RNA-sequencing assay has received certification under the European Union’s In Vitro Diagnostic Regulation as a Class C in vitro diagnostic device. The Chicago-based company said the certification covers its quality management system for “next-generation sequencing devices for cancer genomic profiling to support clinical management.”

xR detects gene rearrangements and specific splice variants in solid tumor tissue to support clinical management. Tempus said the IVDR certification supports continued access to xR in the EU beyond 2028, the transition deadline for eligible legacy Class C devices, and provides biopharma partners with an IVDR-certified testing platform to support clinical studies.

The IVDR Transition Framework

The 2028 deadline referenced in the announcement traces to Regulation 2024/1860, adopted by the European Parliament and the Council on June 13, 2024, and published in the Official Journal of the European Union on July 9, 2024. The regulation amended Regulation 2017/746, the IVDR, to extend transitional periods for certain in vitro diagnostic medical devices.

Under the amended Article 110, devices for which the conformity assessment procedure under Directive 98/79/EC did not require the involvement of a notified body, and for which a declaration of conformity was drawn up before May 26, 2022, may be placed on the market or put into service until December 31, 2027 for class D devices, December 31, 2028 for class C devices, and December 31, 2029 for class B devices and class A devices placed on the market in sterile condition.

The extension carries conditions. Covered devices must continue to comply with Directive 98/79/EC, must undergo no significant changes in design and intended purpose, and must not present an unacceptable risk to the health or safety of patients, users, or other persons. Manufacturers must have had a quality management system in place in accordance with Article 10(8) by May 26, 2025. For class C devices, a formal application to a notified body had to be lodged by May 26, 2026, with a written agreement signed by September 26, 2026.

The regulation’s recitals state that the overall capacity of notified bodies remained insufficient to ensure certification of the large number of in vitro diagnostic devices requiring conformity assessment, and warned of a risk of shortages, especially of highest-risk class D devices, by the prior transition deadline of May 26, 2025.

Assay Design and Cited Clinical Evidence

Tempus’ product documentation describes xR IVD as an FDA-authorized, qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted, high-throughput hybridization-based capture technology to detect BRAF and RET gene rearrangements from RNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens of patients with previously diagnosed solid malignant neoplasms.

The assay runs on the Illumina NovaSeq 6000 platform at a depth of 6 million unique deduplicated reads. It accepts FFPE blocks or unstained slides from previously diagnosed cancer patients with solid malignant neoplasms and requires 20% tumor purity; if purity is below that threshold, microdissection may be completed.

In Tempus’ Chicago laboratory, the assay demonstrated positive percent agreement and negative percent agreement against an externally validated, orthogonal next-generation sequencing method of 92.3% and 100.0%, respectively, for BRAF rearrangements, and 100.0% and 100.0% for RET rearrangements, according to the company. Per the documentation, xR IVD results are intended for use by qualified health care professionals in accordance with professional guidelines in oncology and are not intended to be prescriptive or conclusive for the labeled use of any specific therapeutic product.

The announcement links a published study that Tempus said demonstrated that combining its RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone. The study, presented at ASCO 2022 and posted May 26, 2022, retrospectively analyzed a de-identified dataset of approximately 80,000 samples from 77,400 patients profiled with the Tempus xT assay, which combines DNA sequencing with fusion detection in 21 genes and whole-exome capture RNA sequencing. The researchers used OncoKB to identify level 1 and 2 fusion alterations and those indication-matched to targeted therapies.

The authors identified 2,118 level 1 and 2 fusion events across 1,945 patients and 20 cancer types, most frequently in non-small cell lung cancer (25%) and biliary cancer (9%) samples. Of the 2,118 events, 29.1% (616) were detected only through RNA sequencing, while 4.8% (101) were identifiable only through DNA sequencing. In low-grade glioma, 69.4% of fusions were detected only by RNA sequencing; in sarcomas, the figure was 58.2%.

Of 1,106 fusions classified as targetable by OncoKB indication-matched therapies, 19% (214) were identifiable through RNA sequencing alone, 5% (54) through DNA sequencing alone, and 76% (838) through both. Fusions identified through RNA sequencing alone led to a 24% increase in the number of patients eligible to receive matched therapies (214 of 892), the authors reported, including imatinib for patients with CML/BLCL (69.8%), crizotinib for non-small cell lung cancer (40.3%), and entrectinib for NTRK and ROS1 fusions (32.5%). The authors concluded that the addition of RNA sequencing to DNA sequencing significantly increased the detection of fusion events and the ability to match patients to targeted therapies, supporting consideration of combined RNA-DNA sequencing for standard-of-care fusion calling.

“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally,” said Lauren Silvis, SVP of External Affairs at Tempus. “This achievement establishes a strong regulatory foundation in Europe as we work to expand access to our advanced RNA sequencing tools for healthcare providers, biopharma partners and cancer patients across the region.”

Tempus describes itself as a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, with what it calls one of the world’s largest libraries of multimodal data and an operating system to make that data accessible and useful. The company said it provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates the discovery, development, and delivery of therapeutics.