Q2 Highlights

New Partnerships

We’ve announced a multi-year partnership with the United States Department of Veterans Affairs (VA) National Precision Oncology Program (NPOP) designed to give the VA’s 171 Medical Centers access to our portfolio of next-generation sequencing offerings to support physicians in delivering personalized treatment approaches for their patients with cancer.

Read more in Fierce Biotech

We’ve also announced a new collaboration sponsored by Eli Lilly and Company designed to provide broader access to genomic testing to patients with advanced/metastatic non-small cell lung cancer (NSCLC). This collaboration is intended to help physicians understand the benefits of broad-panel genomic sequencing through clinical practice guidelines. This collaboration aims to provide eligible NSCLC patients access to our genomic tests, to help reduce disparities in biomarker testing and assist physicians in making data-driven treatment decisions.

Read more in Fierce Biotech

Pharma Sequencing and Companion Diagnostics

We have continued to expand our partnerships with life sciences partners in the companion diagnostic space. This includes supporting several early stage clinical trials as an investigational-use only (IUO) test with our targeted DNA panel and full transcriptome RNA sequencing assay. We are actively working with partners on the ingestion and validation of novel gene expression signatures, and continue to support more immunotherapy developers through our immuno-oncology platform including analysis of HLA-loss of heterozygosity.

In addition, we continue to see high growth in our sequencing platform. This quarter’s growth was driven in part by the launch of Tempus’ xF+ liquid biopsy panel, a significant expansion to 523 genes from 105 genes of our previous panel. Our partners are excited to utilize the largest clinically available liquid biopsy test, as this allows them to pursue a more diverse biomarker strategy which now also includes blood tumor mutational burden (bTMB) analysis.

Data

We continue to expand the capabilities of the Tempus Lens self-service data analytics platform. Lens helps Life Sciences companies analyze real-world data for drug development in minutes rather than months–and eliminates the need to build your own IT infrastructure–by delivering access to Tempus multimodal data through an ever-growing number of pre-built data visualizations, analyses, and dozens of templated notebooks.

This past quarter, we launched several new enhancements to Lens, including:

• New pre-built notebooks: Lens’ templated notebooks make it easy to write and execute code to perform a broad range of analyses on records licensed from Tempus. New notebooks in Lens allow you to:
  • Select indications by RNA expression
  • Compare prevalence of genetic mutations by cancer type
  • View prevalence of HLA genotypes
  • Analyze PD-L1 status
  • Identify relevant fibrotic gene signatures
  • and more
• Global search capability: a new feature that allows Lens users to speed up their cohort design by searching across Lens’ data filters to find the inclusion/exclusion criteria you are looking for.
• Ask Tempus: a new feature providing Lens users with the ability to easily reach out to get support and collaborate with Tempus to build and analyze cohorts, license data for their desired cohort, and more.

See Lens in action

Clinical Trials and Studies

We’re making great progress on our Tempus-sponsored interventional clinical trial, PAVO. We have identified over 500 patients who are molecularly eligible for PAVO and have dosed 3 patients in the first 3 months of the study being active. We have 3 active TIME sites and are expecting to open 2 more in the next month.

Our TIME Trial® program continues to grow and has brought 130+ clinical trials to patients in the community. To date, 12,000+ patients have been identified for potential enrollment in clinical trials participating in our patient matching programs. At ASCO, Sibel Blau from Northwest Medical Specialties (a TIME Trial site), gave an oral poster presentation outlining the impact of the TIME Trial program on the ELAINE II (NCT04432454) clinical trial sponsored by Sermonix Pharmaceuticals. TIME Trial was used by Sermonix to achieve First Patient 4 months prior to the first enrolled patients at Academic Medical Centers. Moreover, the TIME network enrolled the first 7 patients onto the study. Sites from TIME Trial ultimately enrolled 45% of the trial’s participants and, as a result, enabled Sermonix to complete its trial enrollment in 8 months (vs the anticipated 12–18 months).

Learn more about this presentation

Biological Modeling

We continue to expand our Biological Modeling platform with new models and capabilities. Tempus’ library of human ex vivo tumor-derived organoids are NGS-qualified and have been pre-screened against a panel of chemotherapies and small molecule therapeutics. Our 3D models support drug screening efforts that drive therapy discovery and development for our life sciences partners and the field in general. We recently published a detailed protocol in Cell Press Star Protocols as a follow up to our initial manuscript in Cell Reports in Larsen et al.

Read about our pan-cancer platform: A Pan-Cancer Organoid Platform for Precision Medicine

In addition to the Tempus PanTumor 60™ and PanTumor IO™ panels, we have added dozens of new organoid models to our fully characterized models library by NGS, four-digit HLA genotyping, and by therapeutic profiling with a panel of standard of care and investigational agents. Our partners continue to see the value in our fully custom organoid models as well, which enables client-selected organoids to be screened with or without allogeneic MHC-matched PBMCs against a wide array of compound classes.

Beyond in vitro organoid models, Tempus Biological Modeling is scaling a world-class data set of tumor single cell and spatially resolved transcriptome data sets. A recent collaboration with investigators at Rush University and Indiana University highlights novel insights in colon cancer derived from single cell transcriptomic data generated at Tempus. We are continually expanding these data sets across indications with both single cell and spatial transcriptomics.

Cardiology

We’re committed to expanding our smart diagnostics to all disease areas and we have a strong focus on cardiology.

In partnership with Geisinger, we have developed an AI model that uses data from a 12-lead ECG to predict patients at risk of undiagnosed structural heart disease. Published in Circulation, the rECHOmmend model can predict seven structural heart diseases that are diagnosable by echocardiography.

This study expands the AI-based cardiology research the Tempus and Geisinger teams have pursued in recent years, starting with a Nature Medicine paper which demonstrated that AI can predict mortality directly from ECG data even in the large subset of ECGs interpreted by physicians as normal. In 2021, a jointly created AI model that can predict risk of new atrial fibrillation (AF) and AF-related stroke was published in Circulation and was later granted Breakthrough Device Designation by the U.S. Food & Drug Administration.

International Expansion

We’re expanding our international presence. In May, we completed CE-IVD certification for our comprehensive portfolio: xT (solid tissue), xF (liquid biopsy), and xE (whole exome). For xT, our CE-IVD includes our full capabilities: DNA, RNA and associated algos HRD, TO, DPYD.

We’ve launched our clinical testing capabilities in Spain, UK, India, Philippines, Malaysia, Thailand, Turkey, Colombia, Egypt, Lebanon, Chile, Portugal and Mexico. We continue to work to expand our commercial presence with the goal of having active sales and marketing efforts in 25 countries by Q3 2022. International samples are sent to and processed in our Chicago lab.

Publications / Presentations

We’ve had several impactful publications and presentations in Q2.

ASCO main presentations and posters

Operational Metrics for the ELAINE II study Combining a Traditional Approach with a Just-in-Time Model
This study demonstrates the success that Tempus’ TIME Trial Program had with Sermonix’s Elaine II trial for patients with ESR1-mutant, estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer. It found that TIME trial sites enrolled their first patient nearly four months faster than traditional sites, and TIME contributed 44.8% of the patients that were enrolled in the study. Ultimately, the Elaine II trial enrolled all patients in eight months, while the anticipated enrollment duration was twelve to eighteen months. Author: Sibel Blau; Northwestern Medical

Clinical RNA-sequencing improves the detection of actionable fusions over DNA-sequencing alone
In the largest fusion analysis of its kind, Tempus reviewed a real-world dataset of 84,938 patient records for improvement in clinically actionable fusion detection due to the inclusion of RNA sequencing. The study found that RNA sequencing identified 29% more patients with clinically actionable fusions that were matched to biomarker linked therapies and that would have been missed by DNA sequencing alone. Author: Ezra Cohen—UCSD

Dual tissue and plasma testing improves detection of actionable variants in patients with solid cancers
This study found that ~4 out of 10 patients had unique actionable variants linked to targeted therapies from doing both solid tumor and liquid biopsy testing that would have been missed by single modality testing alone. In the study, 42% of an overall cohort of 3,153 patients had clinically actionable variants detected through tissue-based comprehensive genomic profiling and/or liquid biopsy. Of these patients with clinically actionable variants, all linked to targeted therapies, 37% were uniquely identified through tissue testing only or by liquid biopsy only. Author: Wade Iams—Vanderbilt Med