Analytical validation of the LungLB test: a 4-color fluorescence in-situ hybridization assay for the evaluation of indeterminate pulmonary nodules.

Autor: Lutman ML; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Gramajo-Leventon D; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Tahvilian S; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Baden L; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Gilbert CL; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Trejo M; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Vail E; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA.; Department of Pathology, Cedars Sinai Medical Center, Los Angeles, CA, USA., Donovan MJ; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA.; Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Katchman BA; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA., Pagano PC; LungLife AI, Inc., 2545 W. Hillcrest Drive, Suite 140, Thousand Oaks, CA, 91320, USA. ppagano@lunglifeai.com.
Jazyk: angličtina
Zdroj: BMC pulmonary medicine [BMC Pulm Med] 2024 Sep 27; Vol. 24 (1), pp. 475. Date of Electronic Publication: 2024 Sep 27.
DOI: 10.1186/s12890-024-03280-7
Abstrakt: Background: Evaluation of indeterminate pulmonary nodules (IPNs) often creates a diagnostic conundrum which may delay the early detection of lung cancer. Rare circulating genetically abnormal cells (CGAC) have previously demonstrated utility as a biomarker for discriminating benign from malignant small IPNs in the LungLB assay. CGAC are identified using a unique 4-color fluorescence in-situ hybridization (FISH) assay and are thought to reflect early cell-based events in lung cancer pathogenesis and the anti-tumor immune response. LungLB is a prognostic tool that combines the CGAC biomarker and clinical features to aid in IPN evaluation by improving the stratification of patient risk of malignancy.
Methods: Herein we describe the analytical performance of the LungLB blood test. Analytical validation was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines with adaptations for rare cell-based assays. Multiple operators, reagent lots, and assay runs were tested to examine accuracy, precision, reproducibility, and interfering factors.
Results: The FISH probes used in the LungLB assay demonstrate 100% sensitivity and specificity for their intended chromosomal loci (3q29, 3p22.1, 10q22.3 and 10cen). LungLB demonstrates analytical sensitivity of 10 CGAC per 10,000 lymphocytes analyzed, 100% analytical specificity, and high linearity (R 2  = 0.9971). Within run measurements across 100 samples demonstrated 96% reproducibility. Interfering factors normally found in blood (lipemia, biotin) and exposure to adverse temperatures (-20ºC or 37ºC) did not interfere with results. Sample stability was validated to 96 hours.
Conclusion: The analytical performance of LungLB in this validation study successfully demonstrates it is robust and suitable for everyday clinical use.
(© 2024. The Author(s).)
Databáze: MEDLINE
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