{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:56:16Z","timestamp":1753869376155,"version":"3.41.2"},"reference-count":42,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,3,8]],"date-time":"2025-03-08T00:00:00Z","timestamp":1741392000000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006769","name":"Russian Science Foundation","doi-asserted-by":"publisher","award":["22\u201075\u201010154"],"award-info":[{"award-number":["22\u201075\u201010154"]}],"id":[{"id":"10.13039\/501100006769","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Next\u2010generation sequencing (NGS) is increasingly integrated into cancer patient management, necessitating cost\u2010effective, reliable tests for companion diagnostics. We present the validation of the Solo\u2010test Driver panel, a custom NGS amplicon\u2010based tool for DNA analysis of 34 oncogenes, addressing key clinical needs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The panel's performance was validated for detecting SNVs, CNVs, and MSI. Analytical validation used 182 samples, while clinical validation involved 130 samples, both encompassing diverse tumor types and specimen formats.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The Solo\u2010test Driver panel has the potential to identify an additional 18.3%, 16.5%, and 8.7% of RAS+ colorectal, PIK3CA+ breast, and EGFR+ lung cancer patients, respectively, when compared to FDA\u2010approved PCR tests. Analytical validation demonstrated high intra\u2010lab robustness (coefficient of variation of coverage uniformity 6.4%) and high inter\u2010lab robustness (PCC of per\u2010amplicon coverage 0.82, 0.84, 0.9 for three different labs). Estimated in silico sensitivity was 100% for detecting clinically actionable SNVs at 250x, corresponding to only 60,000 read pairs per sample. In\u00a0vitro mixing experiments determined LoD starting from 3.3% VAF. Estimated in silico LoD ranged from 0.5% to 5% at 1000\u00d7 (1% to 5% at 650x). Clinical validation demonstrated PPA\/NPA of 100%\/80%, 95%\/100%, and 100%\/100% for detecting MSI, SNVs, and CNVs, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Solo\u2010test Driver panel offers a reliable, cost\u2010effective solution for detecting somatic alterations and genomic signatures, making it suitable for routine companion diagnostics in solid tumors.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.70008","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T21:42:21Z","timestamp":1741729341000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and Clinical Validation of Solo\u2010Test Driver: A Targeted Amplicon\u2010Based <scp>NGS<\/scp> Test\u2010System for <scp>FFPE<\/scp> and <scp>cfDNA<\/scp> Analysis in Clinical Oncology Setting"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9961-0129","authenticated-orcid":false,"given":"Maxim","family":"Ivanov","sequence":"first","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"},{"name":"Sechenov First Moscow State Medical University  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Lebedeva","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"},{"name":"Sechenov First Moscow State Medical University  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7701-8765","authenticated-orcid":false,"given":"Ekaterina","family":"Belova","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"},{"name":"Sechenov First Moscow State Medical University  Moscow Russia"},{"name":"Lomonosov Moscow State University  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatiana","family":"Grigoreva","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"},{"name":"Sechenov First Moscow State Medical University  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Egor","family":"Veselovsky","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Kavun","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anastasiia","family":"Taraskina","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olesya","family":"Kuznetsova","sequence":"additional","affiliation":[{"name":"OncoAtlas LLC  Moscow Russia"},{"name":"Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology  Moscow Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vladislav","family":"Nikulin","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Institution N.N. 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