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What Makes CIRCULOGENE
Best-In-Class?

  • Combines NGS and PCR
  • Increases RNA yields with LISA technology
  • Provides the ONLY liquid PD-L1
  • Offers Enhanced MSI
  • Delivers personalized, actionable reports

ENHANCED cfDNA AND cfRNA YIELDS

CIRCULOGENE begins some tests with a patented Linear In Situ Amplification (LISA) enrichment process resulting in enhanced cfRNA yields. By eliminating the need for a purification step, CIRCULOGENE overcomes the limitations associated with sample volume requirements.  LISA preserves and extracts fragile cfRNA, enabling fusions and plasma PD-L1 to be effectively detected.

COMBINED NGS AND PCR METHODOLOGIES

CIRCULOGENE utilizes both NGS and PCR to provide a comprehensive and extensive marker portfolio resulting in accurate results. Rather than limiting the analytical process by only performing NGS, the addition of PCR enables other actionable markers found in RNA mutations and fusions. By combining NGS and PCR instrumentation, CIRCULOGENE provides the breadth of DNA menu and the depth for RNA detection.

PLASMA PD-L1

The use of LISA and PCR enables CIRCULOGENE to provide the only liquid biopsy method to include plasma PD-L1. CIRCULOGENE’s PD-L1 has also been demonstrated to provide valuable information in non-small cell lung cancer (NSCLC) immunotherapy patients.

MSI

The MSI Protocol is designed to provide physicians with a superior, functional, molecular measurement of the level of DNA mismatch repair deficiency demonstrated within their patient’s tumor. MSI-H (high) could be an indication of immunotherapy response in colorectal cancer.

ACTIONABLE REPORTS

Our personalized reports highlight the most significant actionable findings. CIRCULOGENE then provides referenced information on current FDA-approved treatment options that have proven effective for the tumor cfDNA and cfRNA mutations identified.

SENSITIVITY & SPECIFICITY

Custom NGS Panel SNV & INDELS

Input AF Sensitivity Specificity
10ng 1% 95%
10ng 2.50% 100%
10ng 5% 100%
10ng 98%

For CNV (10ng)

Threshold Sensitivity Specificity
1.4x 100% 97.20%
1.9x 92.60% 100%

RT - PCR Assays

Assays Sensitivity Specificity
PD-L1 Expressions >90% >99%
ALK mRNA Fusion >95% >99%
ROS1 mRNA Fusion >95% >99%
NTRK 1/2/3 mRNA Fusion >95% >99%
MSI Fragmented Analysis >99% >99% >=10% MAF
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