The CellSight DNA assay isolates intact circulating tumor cells rather than cell-free DNA to perform genomic profiling from a single blood draw.
Cancer Cell Diagnostics announced the commercial launch of its CellSight DNA test, which uses intact circulating tumor cells to analyze cancer. This approach differs from most blood-based liquid biopsy tests that analyze cell-free circulating tumor DNA, which are short fragments shed into the bloodstream.
The platform uses a proprietary enrichment method to isolate whole cells from a standard blood draw. This allows clinicians to access 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. Furthermore, because CellSight recovers whole cells, we have a clear path to utilize the same sample well beyond DNA sequencing.”
The next-generation sequencing panel detects several classes of genomic alterations, including single nucleotide variants, insertions and deletions, and copy number variations. It also reports on microsatellite instability status and tumor mutational burden. Molecular testing is conducted at the company’s Clinical Laboratory Improvement Amendments-certified laboratory in Jupiter, Florida.
In analytical validation, CellSight DNA showed a limit of detection of 5% for single nucleotide variants. The test demonstrated analytical sensitivity greater than 99% and a positive predictive value greater than 97%.
Because the isolation technique preserves whole cells, the company intends to expand the platform to support future applications across RNA, protein, and multiomics. This capability is intended to allow the company to expand its testing menu as the science matures.
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