Integrated Biomarkers for the Management of Indeterminate Pulmonary Nodules

Kammer, Michael N.; Lakhani, Dhairya A.; Balar, Aneri B.; Antic, Sanja; Kussrow, Amanda; Webster, R.L.; Mahapatra, S.; Barad, Udaykamal; Shah, Chirayu; Atwater, Thomas; Diergaarde, Brenda; Qian, Jun; Kaizer, Alexander; New, Melissa; Hirsch, Erin; Feser, William J.; Strong, J S; Rioth, Matthew J.; Miller, York E.; Balagurunathan, Yoganand; Rowe, Dianna J.; Helmey, Sherif; Chen, Sheau-Chiann; Bauza, Joseph; Deppen, Stephen A.; Sandler, Kim L.; Maldonado, Fabien; Spira, Avrum; Billatos, Ehab; Schabath, Matthew B.; Gillies, Robert J.; Wilson, David O.; Walker, Ronald C.; Landman, Bennett A.; Chen, Heidi; Grogan, Eric L.; Barón, Anna E.; Bornhop, Darryl J.; Massion, Pierre P.

doi:10.1164/rccm.202012-4438oc

Cited by 45 publications

(32 citation statements)

References 59 publications

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“…Our evaluation of the analytical performance of the CYFRA 21-1 assay in 25% serum is presented in the context of evaluating IPN patient samples. 33 We employed a commercial antibody (Ab) to the target biomarker, CYRFA 21.1 (MyBioSource, San Diego). Characterization and selection of this Ab involved a simple screening experiment with several Ab’s, as described in detail elsewhere.…”

Section: Resultsmentioning

confidence: 99%

“…The data shown here was generated in the context of an ongoing multisite prospectively collected, retrospective blinded evaluation (PROBE) design trail 49 to determine the clinical utility of adding hs-CFRA 21.1 by FSA-CIR as a biomarker to the clinical problem of discrimination of cases from controls in lung cancer patients with indeterminate pulmonary nodules (IPNs). 33 Here, our focus was on the analytical performance of the assay methodology to demonstrate that a manual, first-generation prototype instrument provides excellent performance over multiple days of biomarker analysis research. We are acutely aware that to have an ongoing impact in the clinical setting, refinement of our instrument and assay will be necessary.…”

Section: Discussionmentioning

confidence: 99%

“… 10 This observation led to a larger study that showed there is promise for improving management of patients with IPNs using a CYFRA 21.1 assay, with improved LOQs. 33 …”

Section: Introductionmentioning

confidence: 99%

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Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination

et al. 2022

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CYFRA 21.1, a cytokeratin fragment of epithelial origin, has long been a valuable blood-based biomarker. As with most biomarkers, the clinical diagnostic value of CYFRA 21.1 is dependent on the quantitative performance of the assay. Looking toward translation, it is shown here that a free-solution assay (FSA) coupled with a compensated interferometric reader (CIR) can be used to provide excellent analytical performance in quantifying CYFRA 21.1 in patient serum samples. This report focuses on the analytical performance of the high-sensitivity (hs)-CYFRA 21.1 assay in the context of quantifying the biomarker in two indeterminate pulmonary nodule (IPN) patient cohorts totaling 179 patients. Each of the ten assay calibrations consisted of 6 concentrations, each run as 7 replicates (e.g., 10 × 6 × 7 data points) and were performed on two different instruments by two different operators. Coefficients of variation (CVs) for the hs-CYFRA 21.1 analytical figures of merit, limit of quantification (LOQ) of ca. 60 pg/mL, B max , initial slope, probe–target binding affinity, and reproducibility of quantifying an unknown were found to range from 2.5 to 8.3%. Our results demonstrate the excellent performance of our FSA-CIR hs-CYFRA 21-1 assay and a proof of concept for potentially redefining the performance characteristics of this existing important candidate biomarker.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination

et al. 2022

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“…Continuing the theme of digital transformation, artificial intelligence methodologies are also predicted to help address areas of concern for screening, that of overdiagnosis and incidental findings, through optimal management of pulmonary nodules (radiomics and biomarkers 12 ) and by guiding clear and consistent management pathways for incidentally detected comorbidities 13 . The field of deep learning and neural networks is expanding exponentially and is now focussed well beyond simply ‘detecting’ nodules.…”

Section: Figurementioning

confidence: 99%

Lung cancer screening—Marching along …

2022

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“…In this issue of the Journal ( 3 ), Kammer and colleagues (pp. 1306–1316 ) evaluated a combined set of biomarkers incorporating clinical data (Mayo; incorporating variables easily available in the medical record and radiology report) ( 4 ), a blood-based biomarker (a high-sensitivity measurement of the cytokeratin fragment 21-1 [hs-CYFRA 21-1]) ( 5 ), and radiomic features extracted from computed tomographic images of the nodule ( 6 ).…”

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Integrated Biomarkers for Pulmonary Nodules: Proving What Is Possible

Arenberg

2021

Am J Respir Crit Care Med

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Integrated Biomarkers for the Management of Indeterminate Pulmonary Nodules

Cited by 45 publications

References 59 publications

Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination

Assay Performance of a Label-Free, Solution-Phase CYFRA 21-1 Determination

Lung cancer screening—Marching along …

Integrated Biomarkers for Pulmonary Nodules: Proving What Is Possible

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