Tempus, a leader in artificial intelligence and precision medicine, today announced that it has CE marked a collection of its broad-panel genomic sequencing assays and predictive algorithm laboratory-developed tests. Alongside xT, its primary broad-panel, next-generation sequencing assay, already available on the market, additional Tempus CE marked tests are now available for clinical use in Europe, offering a comprehensive portfolio of oncology assays for use by clinicians.
“We look forward to expanding access to our comprehensive molecular profiling offerings in the market. Our intelligent diagnostics are unique in that they provide clinical context to each diagnostic report, enabling physicians to deliver truly personalized care to their patients,” said Eric Lefkofsky, Founder and CEO of Tempus. “Our focus has always been to make our intelligent diagnostics available to as many patients as possible and expansion in Europe is an important next step toward that goal.”
European clinicians and their patients can now benefit from Tempus’ offerings that support patients being matched to precision therapies supported by all levels of therapeutic evidence tiers. Matched therapies are further advanced through RNA sequencing and immunotherapy biomarker results. The use of tumor-normal (germline) sequencing data leads to substantial improvements in the accuracy of somatic mutation identification. Finally, dual tissue and plasma testing that can improve detection of actionable variants is now accessible to European clinicians and their patients. Each assay is an in vitro diagnostic device that was CE marked under the In Vitro Diagnostic Devices Directive (98/79/EC).
- Tempus|xF: The 105-gene liquid biopsy assay for the detection of single nucleotide variants (SNVs), indels, copy number variations (CNVs), translocations in certain genes, and microsatellite instability (MSI) status using cell-free DNA (cfDNA).
- Tempus|xE: The whole exome assay is used to detect SNVs, indels, and CNVs, as well as MSI status and Tumor Mutational Burden (TMB).
- Tempus|RNA: Tempus’ RNA assay that sequences the whole transcriptome with validated fusion detection used to identify oncologically-relevant fusions and altered splicing events.
- Tempus|HRD: Tempus offers two different HRD assays, HRD-DNA and HRD-RNA. The HRD-DNA test determines homologous recombination deficiency (HRD) status in breast and ovarian cancers based on genome-wide loss of heterozygosity (GWLOH) or evidence of biallelic BRCA1 or BRCA2 loss. HRD-RNA test aims to predict the HRD status of patients by probabilistically determining a HRD score based on whole-transcriptome RNA expression signatures.
- Tempus|TO: TO is intended to identify the probable cancer subtype for cancers of unknown or uncertain primary tissue of origin and uses tumor gene expression profiles. The TO test compares a patient’s tumor molecular data to a large internal database of annotated tumor data to identify a likely diagnosis that may impact standard of care therapy decisions, clinical trial enrollment, and reimbursement for therapies.
- Tempus|DPYD: Using DNA isolated from normal blood or saliva specimens, DPYD assay detects specific alterations in the DPYD gene to aid clinicians in identifying previously diagnosed patients with solid tumor cancer at increased risk of toxicity when considering 5-fluorouracil and capecitabine chemotherapy treatment.
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 clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make near real-time, data-driven decisions 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 www.tempus.com.