{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T06:07:38Z","timestamp":1779430058080,"version":"3.53.1"},"reference-count":16,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2016,8,1]],"date-time":"2016-08-01T00:00:00Z","timestamp":1470009600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["ASSAY and Drug Development Technologies"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:p>\n                    <jats:italic toggle=\"yes\">We previously reported clinical performance of a novel noninvasive and quantitative PCR (qPCR)-based molecular diagnostic assay (the pigmented lesion assay; PLA) that differentiates primary cutaneous melanoma from benign pigmented skin lesions through two target gene signatures, LINC00518 (LINC) and preferentially expressed antigen in melanoma (PRAME). This study focuses on analytical characterization of this PLA, including qPCR specificity and sensitivity, optimization of RNA input in qPCR to achieve a desired diagnostic sensitivity and specificity, and analytical performance (repeatability and reproducibility) of this two-gene PLA. All target qPCRs demonstrated a good specificity (100%) and sensitivity (with a limit of detection of 1\u20132 copies), which allows reliable detection of gene expression changes of LINC and PRAME between melanomas and nonmelanomas. Through normalizing RNA input in qPCR, we converted the traditional gene expression analyses to a binomial detection of gene transcripts (<\/jats:italic>\n                    i.e.\n                    <jats:italic toggle=\"yes\">, detected or not detected). By combining the binomial qPCR results of the two genes, an improved diagnostic sensitivity (raised from 52%\u2013 65% to 71% at 1\u2009pg of total RNA input, and to 91% at 3\u2009pg of total RNA input) was achieved. This two-gene PLA demonstrates a high repeatability and reproducibility (coefficient of variation &lt;3%) and all required analytical performance characteristics for the commercial processing of clinical samples.<\/jats:italic>\n                  <\/jats:p>","DOI":"10.1089\/adt.2016.724","type":"journal-article","created":{"date-parts":[[2016,8,9]],"date-time":"2016-08-09T14:58:03Z","timestamp":1470754683000},"page":"355-363","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Analytical Characteristics of a Noninvasive Gene Expression Assay for Pigmented Skin Lesions"],"prefix":"10.1177","volume":"14","author":[{"given":"Zuxu","family":"Yao","sequence":"first","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Talisha","family":"Allen","sequence":"additional","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret","family":"Oakley","sequence":"additional","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Samons","sequence":"additional","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darryl","family":"Garrison","sequence":"additional","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Burkhard","family":"Jansen","sequence":"additional","affiliation":[{"name":"DermTech, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2016,8,1]]},"reference":[{"key":"e_1_3_3_2_2","first-page":"301","article-title":"The evolution of melanoma diagnosis: 25 years beyond the ABCDs","volume":"60","author":"Rigel DS","year":"2010","unstructured":"Rigel DS, , Russak J, , Friedman R: The evolution of melanoma diagnosis: 25 years beyond the ABCDs. 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Late-Breaking Abstract, AAD, 74th Annual Meeting, Washington, DC, March 4\u20138, 2016."},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2004.08.034"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.5858\/2009-0623-RAR1.1"},{"key":"e_1_3_3_13_2","unstructured":"Frisch NK: Molecular Diagnostics of Melanoma in Clinical Practice. Newspath. www.cap.org\/apps\/docs\/newspath\/1305\/melanoma_clinical_practice.pdf (accessed June2016)."},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2011.10239.x"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2014.04.042"},{"key":"e_1_3_3_16_2","unstructured":"Lazaruk K Wang Y Zhong J et al.: The design process of quantitative TaqMan gene expression analysis tools. White Paper. 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