xR IVD

The Tempus xR IVD is a next-generation sequencing-based in vitro diagnostic device that detects gene rearrangements (specifically in RET and BRAF genes) in RNA extracted from formalin-fixed paraffin-embedded tumor tissue specimens. It is intended for use by qualified healthcare professionals to provide tumor profiling information for patients with previously diagnosed solid malignant neoplasms, in accordance with professional oncology guidelines, and results are not intended to be prescriptive for specific therapeutic use.

xR IVD uses RNA (versus DNA in the predicate MSK-IMPACT), the Illumina NovaSeq 6000 sequencer (versus HiSeq 2500), and detects translocations in two genes only (RET and BRAF) rather than a broad multi-gene panel with SNVs and indels. Both use hybrid-capture next-generation sequencing, report results in two clinical significance levels, employ controls and quality thresholds, and target FFPE tumor specimens from previously diagnosed cancer patients for prescription use only.

ISO 13485:2016 (QMS), ISO 14971:2019 (risk management), ISO 15223-1:2021 and ISO 20417:2021 (labeling), IEC 62366-1:2015 (usability), IEC 62304:2006+A1:2015 (software lifecycle), CLSI EP17-A2 (limit of detection), AAMI TIR 45:2012 (agile software development), FDA guidance on cybersecurity (2023-09 and 2016-12).

Both devices are qualitative NGS-based tumor profiling tests using hybrid-capture methodology on FFPE tissue to detect genomic alterations in cancer patients, with results reported in two clinical significance categories and intended use by qualified professionals per guidelines. Although xR IVD differs in specimen type (RNA vs. DNA), instrument (NovaSeq vs. HiSeq), alteration types (translocations only vs. broad panel), and scale, these differences do not raise distinct safety or effectiveness issues because both employ equivalent quality control metrics, cut-offs appropriate to their respective nucleic acid type, and comparable precision, sensitivity, and specificity performance demonstrated across multiple tumor types.