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Large U.S. Study Validates BiliSeq Test That Nearly Doubles Bile Duct Cancer Detection

The DNA/RNA sequencing assay delivers clearer diagnoses that shape therapy and transplant choices.

Overview

  • The peer-reviewed study, published Friday in Gastroenterology, found BiliSeq detected about 82% of bile duct cancers versus 44% with pathology alone, and nearly 90% when the two were combined.
  • Researchers designed BiliSeq for patients with bile duct narrowing or blockages who need a diagnosis, not for general-population screening.
  • The six-year, prospective trial evaluated nearly 3,000 specimens from more than 2,000 patients across 28 U.S. medical centers.
  • In high-risk groups, detection improved most for primary sclerosing cholangitis, rising from about 26% with pathology to roughly 85% with BiliSeq.
  • The test identified treatment-relevant genetic changes in about 20% of positive cases, leading doctors to adjust care in roughly one-third of those, and UPMC is using results to help determine eligibility for a living-donor liver transplant program.