Tempus AI receives European IVDR certification for xR cancer profiling

European access beyond 2028 gained regulatory support as Tempus AI, Inc. NASDAQTEM announced Class C certification for its xR solid-tumour RNA profiling assay on Monday. The next business update is scheduled for Nov. 2, although the announcement gives no dated European expansion plan.

The company's Oct. 26 release says xR received certification under the European Union's In Vitro Diagnostic Regulation, or IVDR. The assay detects gene rearrangements and specific splice variants in tumour tissue to support clinical management. Certification also covers its quality management system for next-generation sequencing devices used in cancer genomic profiling.

Tempus is a large Chicago-based healthcare technology company providing molecular diagnostics and data tools to physicians and drug developers.

Shares last closed at US$67.62 in New York on Oct. 23 at 4:00 p.m. EDT NASDAQTEM. That quote predates Monday's announcement, so it provides no measure of the market's reaction to certification.

Tempus says certification supports continued EU access beyond the transition deadline for eligible legacy Class C devices in 2028. It also provides biopharma partners with an IVDR-certified testing platform for clinical studies, but the release identifies no new country launch, reimbursement agreement or European sales target.

"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 senior vice-president of external affairs Lauren Silvis said.

RNA Finds Fusions That DNA Testing Misses

The scientific rationale is that adding RNA analysis can identify actionable gene fusions missed by DNA testing alone. In a May 26, 2022 analysis, Tempus retrospectively assessed about 80,000 samples using paired RNA and DNA sequencing.

Of 2,118 actionable fusion events, 29.1 per cent were detected only through RNA sequencing. The analysis used xT testing and included only patients with successful results from both methods, so its findings should not be read as a standalone performance estimate for the newly certified xR assay.

Non-small cell lung and biliary cancers were among the tumour types studied. The analysis measured fusion detection rather than whether testing improved survival, a separate question from the efficacy of treatments selected for molecularly defined cancers.

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Illumina, Inc. NASDAQILMN offers another approach to tumour profiling. Its March 15, 2022 European launch announcement described TruSight Oncology Comprehensive as a diagnostic kit evaluating DNA and RNA across 517 cancer-relevant genes. Tempus' announcement contains no direct comparison with that kit.

The broader iShares Biotechnology ETF NASDAQIBB closed at US$207.74 on Oct. 23 at 4:00 p.m. EDT, providing a sector reference that also predates the news.

Certification Supports Continued EU Access

The European compliance timetable stems from Regulation (EU) 2017/746 and its amended transition provisions. The European Commission says extended periods apply only to eligible legacy devices subject to conditions, including no significant change in design or intended purpose.

Tempus' July 30 financial report put June-quarter diagnostics revenue at US$289.3 million, up 20 per cent from a year earlier. Cash and marketable securities totalled US$820.7 million at June 30; those company-wide figures do not establish the commercial contribution of European xR testing.

Tempus will report third-quarter results before U.S. markets open on Nov. 2 and provide a business update that morning. That report will show whether diagnostics growth continued.