{"entity":{"id":"idea-acc-reflex-genomic-profiling-at-diagnosis","kind":"idea","name":"Pathologists order genomic profiling automatically at diagnosis of advanced cancer","aka":[],"tldr":"A substantial share of patients with advanced non-small-cell lung cancer start first-line treatment before their biomarker results arrive, or without full testing, and so miss targeted therapy. Letting the pathologist order the full genomic panel the moment a cancer of a defined type and stage is confirmed shortens time to result and makes testing complete.","summary":"Real-world data show that a substantial fraction of patients with advanced NSCLC begin first-line therapy before biomarker results are available or without full testing, forgoing targeted therapy. Reflex testing, ordered by the pathologist at diagnosis on defined tumour types and stages, shortens time to result and increases completeness. Tissue stewardship, funding, and a default panel need agreement. Some regions have adopted reflex testing; most have not.","asOf":"2026-09-08","links":[{"label":"Sadik et al., Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non-Small-Cell Lung Cancer (JCO Precis Oncol 2022)","url":"https://doi.org/10.1200/PO.22.00246"},{"label":"Savaloja Pineault et al., Standardized protocols for reflexing to a multigene panel in non-small cell lung cancer: prevalence and perceived barriers (Am J Clin Pathol 2026)","url":"https://doi.org/10.1093/ajcp/aqag077"},{"label":"Smilnak et al., Next-Generation Sequencing Completion and Timeliness Using a Reflex Testing Protocol in Stage II to IV Nonsquamous NSCLC (Clin Lung Cancer 2026)","url":"https://doi.org/10.1016/j.cllc.2026.06.012"},{"label":"Major et al., Implementation of a next-generation sequencing and PD-L1 immunohistochemistry reflex testing protocol improves turnaround time (Am J Clin Pathol 2025)","url":"https://doi.org/10.1093/ajcp/aqaf107"},{"label":"Bottleneck evidence (Fragmented care and guideline gaps): Hanna et al., Mortality due to cancer treatment delay: systematic review and meta-analysis (BMJ 2020)","url":"https://doi.org/10.1136/bmj.m4087"}],"tags":["protocol-upgrade","upgrade:promising","evidence:moderate","precision"],"related":["idea-acc-reflex-biomarker-panels-by-tumour"],"cancers":["nsclc","colorectal"],"sections":[],"technologies":["cgp","companion-diagnostic"],"targets":[],"drugs":["foundationone-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["first-line","ngs"],"trials":[],"people":[],"bottlenecks":["b-care-fragmentation","b-biomarker-validation"],"keyPapers":["paper-hanna-bmj"],"journals":[],"dependsOn":[],"notes":["Protocol upgrade, graded promising: the benefit of matched targeted therapy is established, but the evidence that reflex ordering itself improves outcomes comes from before-and-after series rather than randomised comparisons. At one academic centre with a reflex protocol, 61.0 per cent of 501 patients with stage II to IV non-squamous non-small-cell lung cancer had sequencing results before any first treatment and 88.4 per cent before systemic therapy (Smilnak, 2026); at another, the median time from procedure to sequencing report fell from 22 to 20 days after reflex ordering began (Major, 2025).","Adoption gap, as measured: in United States claims and laboratory data from an industry repository, 497 of every 1,000 patients with newly diagnosed advanced non-small-cell lung cancer were lost to precision oncology at the testing steps, and 29.2 per cent of those who did receive a result did not receive the matching treatment (Sadik, 2022). In a national survey of 111 professionals involved in lung cancer biomarker testing, 77.5 per cent reported an institutional protocol and 88.4 per cent of those protocols reflexed to a multigene panel, but fewer reported results arriving before the visit at which first-line treatment was chosen; reimbursement, insurance authorisation and the Medicare 14-day rule were the barriers named (Savaloja Pineault, 2026)."],"hypothesis":"Reflex comprehensive profiling will increase the proportion of advanced NSCLC and colorectal cancer patients with complete guideline biomarker results before first-line treatment from under 60% to above 90%, and increase targeted-therapy use in eligible patients.","rationale":"Reflex HER2 and ER testing in breast cancer is universal and uncontroversial; extending the same logic to genomic panels removes an avoidable coordination failure.","test":"A regional switch to reflex ordering with pre-post measurement of completeness, turnaround, targeted-therapy uptake, and tissue-exhaustion rates.","maturity":"being-tested-at-scale","actor":"clinic","cost":"medium","horizonYears":2},"route":"/ideas/idea-acc-reflex-genomic-profiling-at-diagnosis/","neighbours":{"idea":[{"id":"idea-acc-reflex-biomarker-panels-by-tumour","kind":"idea","name":"Standing reflex biomarker panels per tumour type, run without an oncologist's order","route":"/ideas/idea-acc-reflex-biomarker-panels-by-tumour/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"}],"drug":[{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"}],"term":[{"id":"first-line","kind":"term","name":"Lines of therapy","route":"/terms/first-line/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-care-fragmentation","kind":"bottleneck","name":"Fragmented care and guideline gaps","route":"/bottlenecks/b-care-fragmentation/"}],"paper":[{"id":"paper-hanna-bmj","kind":"paper","name":"Mortality due to cancer treatment delay: systematic review and meta-analysis","route":"/key-papers/paper-hanna-bmj/"}]}}