{"entity":{"id":"one-lambda","kind":"company","name":"One Lambda","aka":["One Lambda, Inc.","One Lambda Inc."],"tldr":"Californian maker of tissue-typing tests, a Thermo Fisher Scientific subsidiary, whose HLA sequencing system is the FDA companion diagnostic for tebentafusp and afamitresgene autoleucel.","summary":"One Lambda, Inc., the applicant at West Hills, California on the FDA record for its SeCore CDx HLA Sequencing System (BK241074, 1 August 2024), makes HLA typing products. The FDA companion diagnostic list names it as maker of SeCore CDx HLA for tebentafusp in uveal melanoma and for afamitresgene autoleucel in synovial sarcoma. Thermo Fisher Scientific lists One Lambda, Inc, a California company, among its subsidiaries in the exhibit to its annual report for 2025.","asOf":"2026-11-03","links":[{"label":"FDA 510(k) BK241074","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=BK241074"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"label":"Thermo Fisher Scientific 10-K for 2025, Exhibit 21: subsidiaries (SEC)","url":"https://www.sec.gov/Archives/edgar/data/97745/000009774526000018/q4202510-kex21sublist.htm"}],"tags":[],"related":[],"cancers":["uveal-melanoma","synovial-sarcoma"],"sections":["diagnostics"],"technologies":["companion-diagnostic"],"targets":[],"drugs":["secore-cdx-hla"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hq":"West Hills, CA","country":"US","companyType":"diagnostics","stage":"acquired","investors":[],"funding":[],"acquiredBy":"thermo-fisher"},"route":"/companies/one-lambda/","neighbours":{"cancer":[{"id":"synovial-sarcoma","kind":"cancer","name":"Synovial sarcoma","route":"/cancers/synovial-sarcoma/"},{"id":"uveal-melanoma","kind":"cancer","name":"Uveal melanoma","route":"/cancers/uveal-melanoma/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"drug":[{"id":"secore-cdx-hla","kind":"drug","name":"SeCore CDx HLA Sequencing System","route":"/drugs/secore-cdx-hla/"}],"company":[{"id":"thermo-fisher","kind":"company","name":"Thermo Fisher Scientific","route":"/companies/thermo-fisher/"}]}}