{ "id": "AIBD-0068", "title": "Imagene AI infers EGFR mutation from an H&E slide, letting a woman with leptomeningeal lung cancer start osimertinib two days after biopsy and avoid neuraxis radiotherapy", "summary": "Imagene AI predicted EGFR from an H&E slide in <48 h; rapid PCR confirmed; osimertinib began 2 days post-biopsy, no neuraxis radiotherapy.", "date_observed": "2022-07-01", "date_basis": "unassessed", "date_precision": "unassessed", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "In July 2022 a healthy woman in her early 40s was admitted to Tel Aviv Sourasky Medical Center, Israel. She had a month of worsening headaches. Imaging showed a 2.6 cm left apical lung adenocarcinoma with leptomeningeal spread; biopsy tissue was scarce. To guide gene testing without exhausting tissue, the team ran Imagene's deep-learning algorithm on the H&E slide. Within 48 hours of biopsy it inferred EGFR mutation positivity. A rapid Idylla PCR assay confirmed the L858R exon 21 mutation; osimertinib started two days after biopsy. The authors say that was one week earlier than routine practice and avoided whole-neuraxis radiotherapy. Magnetic resonance imaging (MRI) at two months showed the enhancement gone.", "category": "benefit created", "unexpected": false, "purpose": "Imagene's algorithm is built to infer genomic alteration status from routine pathology slides in order to direct molecular testing; this benefit is its intended function.", "system": "Imagene AI (H&E-based molecular inference)", "model_version": null, "developer": "Imagene", "deployer": "Tel Aviv Sourasky Medical Center", "location": "Tel Aviv, Israel", "domain": "Healthcare - oncology / molecular pathology", "segment": "AI-guided biomarker testing in non-small-cell lung cancer", "benefit_type": "Improved Physical Health", "taxonomy_note": null, "registry_ids": {}, "ratings": [ { "group": "personal", "depth": 3, "reason": "Targeted therapy for leptomeningeal disease started a week earlier and whole-neuraxis radiotherapy was avoided, with MRI improvement at two months. Survival benefit is not reported." }, { "group": "organizational", "depth": 1, "reason": "The slide-based inference let the team choose a single rapid PCR test instead of waiting for sequencing on limited tissue." } ], "ai_role": { "status": "assessed", "statement": "The AI inference directed which rapid test to run; treatment began only after PCR confirmation. The AI therefore changed the sequence and speed of testing rather than the final diagnosis. Authors are Tel Aviv Sourasky / Tel Aviv University clinicians declaring no competing interests. A second patient in the report (February 2023) followed the same path." }, "evidence": [ { "kind": "case report", "citation": "Waissengrin B, Garasimov A, Bainhoren O, Merimsky O, Shamai S, Erental A, Wolf I, Hershkovitz D (2023). Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case report. Journal of Clinical Pathology 76(11):790-792.", "title": "Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/", "date": null, "written_by": "deployer", "quote": "The algorithmic inference identified positivity for EGFR mutation." }, { "kind": "case report", "citation": "Waissengrin B et al. (2023). J Clin Pathol 76(11):790-792 (second quotation).", "title": "Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/", "date": null, "written_by": "deployer", "quote": "The incorporation of the AI solution not only enabled targeted treatment 1 week earlier than in the routine practice" }, { "kind": "case report", "citation": "Waissengrin B et al. (2023). J Clin Pathol 76(11):790-792 (third quotation).", "title": "Artificial intelligence (AI) molecular analysis tool assists in rapid treatment decision in lung cancer: a case report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/", "date": null, "written_by": "deployer", "quote": "resulted in avoiding altogether whole neuroaxis radiotherapy" } ], "replication": { "produced_by": [ "Scanning the diagnostic H&E slide and running the inference within 48 hours of biopsy", "A rapid single-gene PCR assay available for confirmation" ], "must_hold": [ "PCR or sequencing confirmation before treatment", "A tumor with a targetable driver the model can infer" ], "echoes": [ { "date": "2023-02-01", "setting": "Second woman in her early 40s with EGFR-mutant NSCLC at the same center, February 2023; same AI-guided path, MRI improvement at two months", "model_version": null, "outcome": "recurred", "source": "Waissengrin B et al. (2023) J Clin Pathol 76(11):790-792, https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/" } ] }, "paired_incident": { "database": "AI Incident Database", "identifier": "225", "title": "IBM Watson for Oncology Criticized by Customers for Allegedly Unsafe and Inaccurate Cancer Treatment Recommendations", "url": "https://incidentdatabase.ai/cite/225", "severity": null, "group": "personal", "basis": "Same domain and task, AI decision support steering cancer treatment: Watson for Oncology gave allegedly unsafe and incorrect treatment recommendations, harming cancer patients and oncologists, the groups Imagene's EGFR inference served." }, "headline": "Imagene AI infers EGFR from H&E; osimertinib 2 days post-biopsy", "metric": "one week earlier than routine practice and avoided whole-neuraxis radiotherapy", "comparator": { "against": "routine practice, in which comprehensive genomic profiling precedes targeted therapy", "before": "CGP is time-consuming, with the time for diagnosis reaching up to 4 weeks", "after": "targeted treatment 1 week earlier than in the routine practice; osimertinib given 2 days after the biopsy", "basis": "assumed", "quote": "The incorporation of the AI solution not only enabled targeted treatment 1 week earlier than in the routine practice but also resulted in avoiding altogether whole neuroaxis radiotherapy.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/" }, "later": { "status": "persisted", "date": null, "note": "MRI two months after osimertinib began (exact date not given) showed disappearance of the leptomeningeal enhancement in this patient and in the second patient.", "quote": "Both patients' MRI scans after 2 months of TKI showed significant improvement with disappearance of the enhancement.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/" }, "value": null, "developer_country": "Israel", "deployer_country": "Israel", "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-20", "change": "Paired with AI Incident Database incident 225 (medium confidence); severity not given by the source.", "source": "https://incidentdatabase.ai/cite/225", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, what happened since from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/; https://pmc.ncbi.nlm.nih.gov/articles/PMC10646899/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Organizational Efficiency among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://imagene-ai.com/privacy-policy/; https://en.wikipedia.org/wiki/Tel_Aviv_Sourasky_Medical_Center", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" } ], "confidence": "claimed", "shade": "low", "claim_status": "The deployer's account", "claim_basis": "Sources: the deployer's case report. The cited evidence includes no independent source and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0068", "catalog_version": "1.0.0", "source_fingerprint": "f95325356bf6185ad2551e47258c9cbba0b69a755721dbb9d46c0bafd1aac5bd", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0068-source-0001", "AIBD-0068-source-0002", "AIBD-0068-source-0003" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "monetary observations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "institutional decisions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "developer": "Imagene", "deployer": "Tel Aviv Sourasky Medical Center" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "developer", "deployer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "actors[].ownership_control": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "ai_contribution": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ai_role": { "status": "assessed", "statement": "The AI inference directed which rapid test to run; treatment began only after PCR confirmation. The AI therefore changed the sequence and speed of testing rather than the final diagnosis. Authors are Tel Aviv Sourasky / Tel Aviv University clinicians declaring no competing interests. A second patient in the report (February 2023) followed the same path." } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ai_role" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "ai_relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "category": "benefit created", "ai_role": { "status": "assessed", "statement": "The AI inference directed which rapid test to run; treatment began only after PCR confirmation. The AI therefore changed the sequence and speed of testing rather than the final diagnosis. Authors are Tel Aviv Sourasky / Tel Aviv University clinicians declaring no competing interests. 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