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Build early evidence of therapy efficacy, enroll patients most likely to benefit from treatment, and leverage data-driven trial designs to accelerate your drug development1-5.

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Real-world multimodal data

Purpose-built for early-stage cancers and earlier treatment settings

Discover novel biomarkers

Identify molecular subtypes in cancer histologies of interest, particularly powered for early-stage and/or immunotherapy-treated cancers

Characterize genetic alterations

Analyze the prevalence and prognostic or predictive impact of potential drug targets across early- and late-stage cancers

Inform clinical development

Define optimal study populations, support trial design, and assess execution feasibility

Comprehensive multimodal view of tumor biology

Longitudinal ctDNA
Longitudinal ctDNA
For prognostication & response
Tumor DNA
Tumor DNA
WES at 100x coverage
Tumor RNA
Tumor RNA
WTS at 50-150M read depth
Germline DNA
Germline DNA
30x exome
Pathology
Pathology
Digitized H&E slides with 40x magnification
Methylome
Methylome
Whole genome bisulfite sequencing 30M GpG regions
Matched clinical data
Matched clinical data
Continuous abstraction of treatment, response, and outcomes data, with linkage to other sources (e.g., claims)
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Broad representation across tumor types & stages

Top tumor types represented:

Colorectal

Colorectal

Breast

Breast

Lung

Lung

Bladder

Bladder

Gastroesophageal

Gastroesophageal

Melanoma

Melanoma

50+

tumor histologies1

70%+

patients with early-stage cancers1

~40%

US oncologists ordering from Natera1

4+

average molecular tests per patient1

Assess project feasibility in your tumor type of interest
>100k
de-identified records for early-stage cancers1

Contemporary RWD for early stage cancers

Early stage cancer care is changing rapidly, driven by approval of new drugs and molecular diagnostic testing

Leverage contemporary RWD in early stage cancers to:

  • Assess clinical unmet need
  • Identify indication expansion opportunities
  • Predict control arm outcomes
  • Refine patient selection approach & trial design
  • Evaluate trial execution feasibility

Leverage unique longitudinal insights into molecular disease

Incorporation of molecular disease data into your RWD analysis is critical for:

  • Identifying unique subpopulations of patients who are most likely to benefit from a new therapy
  • Augmenting clinical data for a more comprehensive view of treatment response

What is molecular disease?

Circulating tumor DNA (ctDNA) is shed from cancer cells into the bloodstream. These tumor DNA fragments can be identified by the Signatera™ assay, offering an early, quantitative, non-invasive approach to assess treatment response and disease progression.

Across multiple studies, detection of molecular disease by Signatera™ was one of the most significant prognostic risk factors for recurrence2-6

View publications & posters

Figure 1: schematic of tumor cells and ctDNA10

>95%
of patients with molecular disease after definitive treatment are destined to progress or relapse without additional treatment2-10

Unlock new drug development opportunities with molecular disease RWD

With Natera’s technology, this unique population of molecular progressors can be identified as early as weeks after definitive treatment and months ahead of radiographic progression.2-10

Leverage Natera’s RWD to identify these opportunities and prioritize indications

Figure 2: Kaplan-Meier estimates of real-world patients with esophagogastric cancers representing RFS as stratified by anytime ctDNA-positivity6

More comprehensive view of treatment response

Combining molecular response with clinical response can significantly improve data quality and completeness, filling critical data gaps.

Benefits of integrating molecular response data in RWD analyses:

  • Quantitative: Utilize a standardized, objective response measure for readily scalable RWD analysis and mitigate confounding factors such as pseudoprogression
  • Longitudinal: Frequent assessments of molecular response can provide more dynamic, real-time insights into treatment response and disease progression
  • Corroborative: Increase confidence in your results by augmenting clinical data with molecular response indicators

Comprehensive suite of product and services

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Featured publications & presentations

Publications

  1. Huffman BM, Aushev VN, Budde GL, et al. Analysis of circulating tumor DNA to predict risk of recurrence in patients with esophageal and gastric cancers. JCO-Precision Oncology. 2022; 6:e2200420.
  2. Eroglu Z, Krinshpun S, Kalashnikova E, et al. Circulating tumor DNA based molecular residual disease detection for treatment monitoring in advanced melanoma patients. Cancer. 2023;129(11):1723-1734.

Posters & presentations

  1. Cohen S, Kasi P, Aushev VN, et al. Real-world monitoring of circulating tumor DNA reliably predicts cancer recurrence in patients with resected stages I-III colorectal cancer. ESMO, Paris, France, Sept 9-13, 2022. Mini Oral presentation (319MO)
  2. Cohen SA, Kasi PM, Aushev VN, et al. Kinetics of postoperative circulating cfDNA and impact on MRD detection rates in patients with resected stage I-III CRC. Oral presentation presented at ASCO Gastrointestinal Cancers Symposium, San Francisco, CA. Jan 19-21, 2023.
  3. Lander EM, Rivero-Hinojosa S, Aushev VN, et al. Tumor mutational signatures in early-onset versus average-onset colorectal cancer. Oral presentation presented at ESMO GI, Barcelona, Spain, June 28 – July 1, 2023.

How can Signatera™ support your clinical trials?

Contact us to learn more

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References

1Natera Q1 2024 earnings call and internal data from real-world database calculations as of July 2024.

2Kotani D, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nature Medicine. 2023.

3Yukami H, Nakamura Y, Mishima S, et al. Circulating tumor DNA (ctDNA) dynamics in colorectal cancer (CRC) patients with molecular residual disease: Updated analysis from GALAXY study in the CIRCULATE-JAPAN. Oral presentation presented at ASCO Gastrointestinal Cancers Symposium, San Francisco, CA. Jan 18-20, 2024.

4Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nature Cancer. 2020.

5Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell. 2023;41(6):1091-1102.

6Huffman BM, Aushev VN, Budde GL, et al. Analysis of circulating tumor DNA to predict risk of recurrence in patients with esophageal and gastric cancers. JCO-Precision Oncology. 2022; 6:e2200420.

7Powles T, Assaf ZA, Davarpanah N, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021.

8Coombes C, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019.

9Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA in neoadjuvant treated breast cancer reflects response and survival. Annals of Oncology. 2021.

10Abbosh C, Birkbak N, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017.

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