COMPANY

Lumos Diagnostics

Keywords: diagnostics Acute Respiratory Infections SARS-CoV-2 Covid19 Phenylketonurias Covid19 SARS-Cov-2 FebriDx PheCheck™ CoviDx™ Covid-19 Antigen Self-Test POC CoviDx™ Rapid Antigen Test

Profile checked Oct 10, 2026

6Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Mar 24, 2026 FDA FDA 510(k) clearance: FebriDx Bacterial/Non-bacterial Assay — K260787, Mar 24, 2026. Applicant at approval: Lumos Diagnostics, Inc. source ↗
Oct 9, 2025 Trial start —: FebriDx® Pediatric Validation Study source ↗
Dec 20, 2024 Trial start —: FebriDx® Method Comparison Study Protocol source ↗
Dec 15, 2023 Trial start —: PheCheck Feasibility Study source ↗
May 17, 2022 Trial start —: Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™) source ↗
Feb 8, 2021 Trial start —: Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™) source ↗
Jan 5, 2021 Trial start —: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood source ↗

Upcoming milestones

Mar 31, 2027 (ESTIMATED) · · FebriDx® Pediatric Validation Study · NCT07211997

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 6

Record	Title	Phase	Status	Start	Primary completion
NCT07211997	FebriDx® Pediatric Validation Study	Not listed	Recruiting	Oct 9, 2025	Mar 31, 2027 (estimated)
NCT05998109	PheCheck Feasibility Study	Not listed	Completed	Dec 15, 2023	Jul 31, 2024 (actual)
NCT06746259	FebriDx® Method Comparison Study Protocol	Not listed	Completed	Dec 20, 2024	Aug 15, 2025 (actual)
NCT05403346	Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)	Not listed	Terminated	May 17, 2022	Aug 1, 2022 (actual)
NCT04750629	Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)	Not listed	Completed	Feb 8, 2021	May 7, 2021 (actual)
NCT04699903	Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood	Not listed	Completed	Jan 5, 2021	Jan 29, 2021 (actual)

FDA records (last 2 years)

Mar 24, 2026 FDA 510(k) clearance: FebriDx Bacterial/Non-bacterial Assay — K260787, Mar 24, 2026. Applicant at approval: Lumos Diagnostics, Inc. source ↗

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