The test uses intact circulating tumor cells instead of cell-free DNA fragments to analyze more than 500 genes and identify tumor markers.
Cancer Cell Diagnostics announced the commercial launch of CellSight DNA, a genomic profiling test that uses intact circulating tumor cells isolated from a standard blood draw.
While most blood-based cancer tests analyze cell-free circulating tumor DNA—the degraded fragments tumors shed into the bloodstream—the CellSight platform uses a proprietary enrichment method to extract DNA directly from whole cells. According to the company, this allows clinicians to access genomic information from complete tumor biology rather than fragmented remnants.
“We profile more than 500 genes and report tumor mutational burden and microsatellite instability status from a single blood draw,” says Tifiny McDonald, CEO of Cancer Cell Diagnostics, in a release. “Because our technology works from intact circulating tumor cells rather than cell-free circulating tumor fragments, the CellSight platform is designed to provide oncologists with a more comprehensive profile of the tumor.”
Panel Capabilities and Validation
The next-generation sequencing panel detects multiple classes of genomic alterations, including single nucleotide variants, insertions and deletions, copy number variations, microsatellite instability status, and tumor mutational burden.
Molecular testing is performed in the company’s Clinical Laboratory Improvement Amendments-certified laboratory in Jupiter, Florida. In analytical validation conducted under standard operating procedures, the assay demonstrated a limit of detection of 5% for single nucleotide variants. Analytical sensitivity was greater than 99%, and the positive predictive value was greater than 97%.
Future Applications
Because the isolation technique preserves whole cells, the company says the same enriched material can support future applications across RNA, protein, functional analysis, and multiomics.
CellSight DNA is a laboratory-developed test. It has not been cleared or approved by the Food and Drug Administration.
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