The 500+ gene panel leverages intact circulating tumor cells, aiming to provide a clinically superior alternative to standard, fragment-based blood tests.

Cancer Cell Diagnostics today announced the commercial launch of its CellSight™ DNA comprehensive genomic profiling test. This test is built on a fundamentally distinct source material from conventional liquid biopsy.

Most blood-based cancer tests analyze cell-free circulating tumor DNA, the short, degraded fragments that tumors shed into the bloodstream. CCDx utilizes a different approach. The CellSight™ platform uses a proprietary, patent-pending enrichment method to isolate intact circulating tumor cells (CTCs) from a standard blood draw, extracting DNA directly from those cells. This allows clinicians to access genomic information drawn from complete tumor biology rather than fragmented remnants.

"We profile more than 500 genes and report tumor mutational burden (TMB) and microsatellite instability (MSI) status from a single blood draw," said Tifiny McDonald, Chief Executive Officer of CCDx. "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."

CellSight™ DNA is the inaugural assay released on this platform. The next-generation sequencing panel detects comprehensive classes of genomic alterations, including single nucleotide variants, insertions and deletions, copy number variations, microsatellite instability (MSI) status and tumor mutational burden (TMB). Molecular testing is performed in the company's CLIA-certified laboratory in Jupiter, Florida.

In analytical validation performed under standard operating procedures, CellSight™ DNA 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%. Representative insertions and deletions were qualitatively detected across the tested set. CCDx engineered the CellSight™ platform for long-term extensibility. Because the isolation technique preserves whole cells, the same enriched material can support future applications across RNA, protein, functional analysis, and multiomics. This unique capability positions the company to aggressively expand its menu as the science matures.

About Cancer Cell Diagnostics (CCDx)

Cancer Cell Diagnostics is a precision oncology company based in Jupiter, Florida. Its CellSight™ platform isolates intact circulating tumor cells from peripheral blood, enabling comprehensive genomic profiling and downstream molecular and multiomic analyses. Operating a CLIA-certified laboratory, the company is focused on offering clinicians a more complete molecular understanding of each patient's cancer. Learn more at cancercelldx.com.

CellSight™ DNA is a laboratory-developed test. It has not been cleared or approved by the U.S. Food and Drug Administration.

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