Why partner with Signatera^™ for your clinical trial?

Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment¹
Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations
>60 Natera IP assets covering ctDNA MRD and monitoring

Our partners choose Signatera because well-designed and successful clinical trials could facilitate earlier “go/no go” decision-making. A trial with Signatera can ultimately enhance the R&D pipeline productivity and impact label expansion of approved oncology drugs to new treatment settings.

What are the applications of Signatera in a Clinical Trial?

Use case	signatera advantage
Surrogate Endpoint	ctDNA status during and after treatment helps you to predict clinical outcomes as early as 6 weeks into treatment
Patient Enrichment	Select patients likely to respond to therapy due to residual disease presence (i.e., ctDNA positive)
Platform	Identify ‘winning / losing’ regimens faster by enriching and quickly identifying active regimens
Treat on Molecular Relapse	Potential to define new patient population by treating at early identification of relapse vs conventional methods
Immuno-oncology	Potential to improve patient outcomes by avoiding over-treatment, treating to undetectable ctDNA (early stage), and timely switching of therapies
Secondary pools	Track neoantigens, resistance mutations, sub-clonal mutations and driver mutations.

Learn more about Pan-tumor Innovative Clinical Trial Design with Signatera

Growing List of Publicly Announced Studies

PARTNER	INDICATION	PHASE	PRESS RELEASE
Genentech IMvigor011 trial	Bladder cancer	Phase 3	READ MORE
Arhaus University	Bladder cancer	RUO	READ MORE
Imperial College London	Breast cancer	RUO	READ MORE
Institut Jules Bordet	Breast cancer	RUO	READ MORE
Yale and Criterium/Academic Breast Cancer Consortium (ABRCC) network – DARE	Breast cancer	Phase 2	READ MORE
Massachusetts General Hospital – LEADER	Breast cancer	Phase 2	READ MORE
AMAL Therapeutics – KISIMA-01 trial	CRC	Phase 1b	READ MORE
Arhaus University	CRC	RUO	READ MORE
Natera – BESPOKE trial	CRC	Registry trial	READ MORE
NCC Japan – CIRCULATE-IDEA trial	CRC	Registry trial	READ MORE
Fox Chase Cancer Center	Kidney cancer	RUO	READ MORE
Bristol-Myers – TRACERx trial	Lung cancer	Phase 2	READ MORE
Neon Therapeutics – NEO-PV-01 trial	Lung cancer	Preclinical	READ MORE
Elicio Therapeutics – ELI-002 trial	Pancreatic ductal adenocarcinoma (PDAC)	Phase 1/2	READ MORE

Join our BESPOKE Studies

Natera sponsors prospective, multicenter BESPOKE Studies, which examine the clinical utility of the Signatera™ ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors. Want to collaborate with Natera in our current Colorectal Cancer BESPOKE Study?

Is Signatera CLIA or Signatera RUO right for your clinical trial?

Parameter	CLIA	RUO
Purpose	For registrational clinical trials For patient-level clinical decisions	For retrospectively batched sample studies Signal-finding studies, pilots
Turnaround time	2-3 weeks for first sample 5-7 days for subsequent	Longer turnaround times due to customization
Assay variants and design	Personalized and tumor-informed 2 to 16-plex PCR	Flexible in number of variants to track Design customized assays for your targets of interest Run secondary pools from the residual cfDNA library (eg, track neoantigens, actionable mutations, and tumor evolution) Design multiplex PCR from targeted tumor panels, without WES
Number of assays per patient	One 16-plex PCR per patient	Can create up to 4 assays with multiple/synchronous tumors Can create >16-plex assay depending on tumor genome/exome profile
Depth of read	WES >180X average coverage (>70% at 100X) for tumor tissue and >50X average coverage (>70% at 30X) for matched normal sample (blood)	Same as CLIA
Tissue / plasma	Plasma: 2 tubes of whole blood collected in Streck tubes (8-10mL per tube) for ctDNA; 6 mL whole blood collected in EDTA tube for matched normal WES analysis Tissue: 12-20 unstained (charged and unbaked) 5 micron FFPE slides with >5mm2 tumor plus 1 H&E slide (≥20% tumor content)	Plasma: Down to 2 mL from different blood tube types Tissue: >5-6 unstained 5 micron FFPE slides (>15mm2), Pre-extracted tumor or normal DNA, different matched normal sources (PBMC, buffy coat, normal tissue), or pre-sequenced WES/WGS data

Reach out about partnering

References

¹Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.

²Reinert T, Henriksen TV, Rasmussen MH, et al. Serial Circulating Tumor DNA Analysis for Detection of Residual Disease, Assessment of Adjuvant Therapy Efficacy and for Early Recurrence Detection in Colorectal Cancer. Poster presented at: European Society for Medical Oncology Annual Congress; October 21, 2018; Munich, Germany. Abstract 456PD.

³Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: European Society for Medical Oncology Annual Congress; October 20, 2018; Munich, Germany. Abstract 86P.

⁴Coombes RC, Armstrong A, Ahmed S. Early detection of residual breast cancer through a robust, scalable and personalized analysis of circulating tumor DNA (ctDNA) antedates overt metastatic recurrence. Poster presented at: San Antonio Breast Cancer Symposium; December 7, 2018. San Antonio, TX. Abstract 1266.

⁵Magbanua MJM, Brown-Swigart L, Hirst GL. Personalized serial circulating tumor DNA (ctDNA) analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 trial. Poster presented at: San Antonio Breast Cancer Symposium; December 5, 2018. San Antonio, TX. Abstract 1259.

Why partner with Signatera™ for your clinical trial?