Caris Life Sciences study validates blood-based cancer detection assay

Caris Life Sciences (NASDAQ: CAI) announced Tuesday that a study published in Scientific Reports validates the clinical utility of its Caris Assure blood-based assay for cancer detection and monitoring.

The study demonstrates the assay's performance across multiple cancer applications. For multi-cancer early detection, the platform achieved sensitivities of 83.1% to 95.7% across cancer stages I-IV at 99.6% specificity. The assay also showed predictive power for cancer recurrence, with hazard ratios of 33.4 for minimal residual disease detection and 4.39 for therapeutic monitoring.

The Caris Assure platform combines whole exome sequencing and whole transcriptome sequencing with artificial intelligence to analyze over 23,000 genes in blood plasma. The system was trained on more than 376,000 tissue profiles and over 7,000 matched blood and tissue samples.

"We designed Caris Assure to be more than a liquid biopsy test," said David Spetzler, president of Caris Life Sciences. "This is the first time so much molecular information has been available from a single blood test, allowing for increased accuracy and additional insights to inform physicians in helping to make cancer care decisions."

The assay does not require a prior tissue biopsy, instead using AI to identify tumor-derived signals based on patterns learned from tumor data. Currently, Caris Assure is commercially available for therapy selection in advanced cancers.

The company stated it is pursuing reimbursement and regulatory pathways to expand the platform's applications to early detection, minimal residual disease detection, and therapeutic monitoring.

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