Sample Collection

Large sample volume, low-yield and labor-intensiveness are the major barriers to the routine use of cell-free DNA-based testing in current clinical settings. Specifically, cell-free DNA recovery efficiency using the current standard silica membrane/bead method is extremely low due to unavoidable loss in steps such as binding, washing and elution. This in turn results in a minimal sample requirement of 5-10mL of blood.

While almost all liquid biopsy providers are working and perfecting their novel technologies to selectively enrich or amplify tumor-specific, cell-free DNA from a dominantly normal population, their starting materials are still those “incomplete” DNA molecules that survived after extraction/isolation. As a result, no matter how sensitive their technology is (downstream), they cannot detect cell-free DNA already lost during sample preparation (upstream). Further, there is uncertainty if 10 mL of blood is enough.

In contrast, Circulogene Theranostics focuses on the first step in the cell-free DNA process, making sure we capture all of the cell-free DNA molecules existing in the original sample. Our breakthrough, proprietary method enables recovery of both necrotic and apoptotic cell-death-associated, cell-free DNA, with a high-yield, high-degree genomic representation and high sequencing quality.

Sample Quality and Quantity

Circulogene’s proprietary method provides a simple, streamlined, and robust workflow optimized for cell-free DNA enrichment/recovery from a droplet of plasma or serum as an alternative to low-quantity, poor quality DNA from challenging tissue biopsy samples. This sample preparation breakthrough enables multiple analyses on a droplet sample by a broad range of genomic platforms, including next-generation sequencing (NGS), microarrays and qPCR/ddPCR. Working with challenging and precious samples is no longer a barrier to personalized cancer therapy. Our technology allows us to work with a sample volume as small as 50 microliters, saving the remainder of your biobank for other clinical testing.

We compared the sensitivity of our proprietary cell-free DNA enrichment method to the standard DNA extraction kit used industry-wide today. Results demonstrated 100x more cell-free tumor DNA in the original sample using a single drop of blood.

Sensitivity and Accuracy

Circulogene’s cell-free DNA enrichment process is a complete solution for generation of high-yield, high-quality, well-represented tumor DNA from droplet amounts of plasma or serum. It is the first non-invasive method that allows accurate NGS genomic analyses directly from droplet volumes of blood. Our protocol can be applied to a broad range of clinical genetic tests with the advantages of minimal sample volume, maximal yield, and streamlined workflow with reduced cost and turnaround time.

Automation

Cicrulogene’s automated solutions have been developed to streamline the complete next-generation sequencing workflow from sample-in to report-out. The simplicity and robustness of our automatic process enables interfaces and cross-talks between a variety of platforms and laboratory information management systems. Using this simplified workflow, an automated workstation can easily process 96 or more samples at one time.