학술논문
Clinical experience with next-generation sequencing-based liquid biopsy testing for cancer detection in dogs: a review of 1,500 consecutive clinical cases.
Document Type
Article
Author
O'Keli, Allison L.; Lytle, Katherine M.; Cohen, Todd A.; Wong, Lilian K.; Sandford, Emily; Rafalko, Jill M.; Brandstetter, Gina; DiMarzio, Lauren R.; Phelps-Dunn, Ashley; Rosentel, Michelle C.; Warren, Chelsea D.; McCleary-Wheeler, Angela L.; Fiaux, Patrick C.; Marass, Francesco; Marshall, Maggie A.; Ruiz-Perez, Carlos A.; Kruglyak, Kristina M.; Tynan, John A.; Hicks, Susan C.; Grosu, Daniel S.
Source
Subject
*DETECTOR dogs
*EARLY detection of cancer
*DOGS
*BIOPSY
*NUCLEOTIDE sequencing
*LIQUIDS
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Language
ISSN
0003-1488
Abstract
OBJECTIVE To review ordering patterns, positivity rates, and outcome data for a subset of consecutive samples submitted for a commercially available, blood-based multicancer early-detection liquid biopsy test for dogs using next-generation sequencing at 1 laboratory. SAMPLE 1,500 consecutively submitted blood samples from client-owned dogs with and without clinical suspicion and/or history of cancer for prospective liquid biopsy testing between December 28, 2021, and June 28, 2022. PROCEDURES We performed a retrospective observational study, reviewing data from 1,500 consecutive clinical samples submitted for liquid biopsy testing. Outcome data were obtained via medical record review, direct communication with the referring clinic, and/or a patient outcome survey through October 16, 2022. RESULTS Sixty-four percent (910/1,419) of reportable samples were submitted for cancer screening, 26% (366/1,419) for aid in diagnosis, and 10% (143/1,419) for other indications. The positivity rate was 25.4% (93/366) in aid-in-diagnosis patients and 4.5% (41/910) in screening patients. Outcome data were available for 33% (465/1,401) of patients, and outcomes were classifiable for 428 patients. The relative observed sensitivity was 61.5% (67/109) and specificity was 97.5% (311/319). The positive predictive value was 75.0% (21/28) for screening patients and 97.7% (43/44) for aid-indiagnosis patients, and the time to diagnostic resolution following a positive result was < 2 weeks in most cases. CLINICAL RELEVANCE Liquid biopsy using next-generation sequencing represents a novel tool for noninvasive detection of cancer in dogs. Real-world clinical performance meets or exceeds expectations established in the test's clinical validation study. [ABSTRACT FROM AUTHOR]