cfDNA IN URINE

Urine-based cfDNA – More robust variant detection in bladder cancer

Urine is the ideal body fluid for non-invasive molecular profiling of bladder cancer, in which more variants can be identified in urine than in blood. Predicine’s cfDNA liquid biopsy tests can be applied in the clinical setting for treatment selection, treatment monitoring and minimal residual disease (MRD) assessment. 

Pain-free molecular profiling in bladder cancer

Urine-based cfDNA variant detection

Predicine has developed a urine-based liquid biopsy to broaden cancer patients’ access to genomic profiling. Urine-based cfDNA can be more robust in variant detection than blood-based cfDNA in genitourinary cancers.

Ultra-sensitive variant detection

  • Low input profiling with as little as 2mL of urine.
  • Detects copy number loss in addition to copy number gain, SNVs, Indels, and fusions.

Actionable insights

  • Custom-built cfDNA monitoring assay to support optimal cancer treatment planning in oncology.
  • Identifies tumor mutations at the source, enabling highly accurate monitoring of disease over time.

In clinical studies, Predicine's cfDNA assays show high performance across multiple tumor types

Comparable performance between Predicine and Guardant Health's cfDNA platforms

cfDNA: Predicine vs Guardant

An independent study reports a comparable performance between Predicine and Guardant Health’s cfDNA platforms, demonstrating additional prognostic value of Predicine’s cfDNA assay related to treatment benefit and overall survival.

Study from Northwestern Univeristy.

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cfDNA and cfRNA molecular profiling in CRC

Clinical feasibility of simultaneous multiparametric profiling using Predicine’s combined cfDNA and cfRNA liquid biopsy approach for molecular characterization in advanced colorectal cancer.

Collaboration with Merck and EMD Serono.

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cfDNA-based copy number loss detection

Validation of Predicine cfDNA assay that detects copy number loss (CNL) in addition to copy number gain (CNG),  SNV, Indel, and rearrangement in blood and urine. 

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Urine-based TMB in bladder cancer

Tumor tissue correlates better with urine than with blood. Correlation of TMB in matched urine and tissue samples is higher than matched plasma and tissue samples.

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Robust variant detection in urine

A biomarker study demonstrating cross-specimen variant detection in NMIBC and MIBC.

 

Clinical application of urine cfDNA test

Currently, Predicine’s urine-based cfDNA test is used in Phase I-III trials in US, EU, and APAC (including China). 

Urine-based cfDNA assays

Biology-oriented liquid biopsy solutions to support clinical trials

PredicineATLAS™

RUO

• 600 genes
• TMB and MSI status
• Variant profiling

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PredicineCARE™

CLIA and RUO

• 152 genes
• 80+ FDA approved therapies
• Includes copy number loss/gain

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PredicineMRD™

RUO

• Indication specific
• Ultra-sensitive variant detection
• Superior to amplicon-based assay

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How it works

10 days turnaround

How much urine is required for the test?

40mL of urine is required for Predicine’s cfDNA assays.

What other specimen types are compatible with Predicine NGS test?

Plasma (2-4ml)
Whole blood (4-10ml)
FFPE (10 slides; 25 mm² surface size; 20% tumor content)

Where is Predicine's laboratory located?

Predicine’s laboratory is located at Hayward (San Francisco Bay Area) in California.

Is Predicine's laboratory CLIA-certified and CAP-accredited?

Predicine’s laboratory is both CLIA-certified and CAP-accredited. See Predicine’s list of certifications at https://predicine.com/about/#laboratory

What is the turnaround time?

10 days.

Which phases of clinical trials do you support?

Currently, Predicine is working with leading pharma to support global clinical trials from Phase I to III. Patient samples are shipped to Predicine’s laboratory from trial sites in US, EU, and APAC (including China).

Do you test clinical trial samples from US, EU, and China?

Yes. Patient samples collected at trial sites in US, EU, and APAC are shipped to Predicine’s laboratory in Hayward, CA. Patient samples collected at trial sites in China are shipped to Predicine’s laboratory in Shanghai, China.

Questions? Contact us.

If you have any questions or want additional information, please reach out to us.  We will get back to you within 24 hours.