Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)

Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)

This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions. The purpose of this study is to collect blood samples to help develop, improve, and fine-tune new and existing diagnostic tests for the cobas® lumira instrument. This instrument is a diagnostic medical device with single-use test strips, that allows diagnostic testing right at the patient's side. The aim is to improve doctors' ability to monitor health conditions more quickly and easily.

Approximately 30,000 patients are expected to participate in this study, across multiple UK sites.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Heart Disease; Liver Disease; Kidney Disease; High Cholesterol; Blood Clots; Infection and Inflammatory Reaction; Vitamin K Antagonist
• Intervention / Treatment: Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Zoe Pounce, PhD; Phone Number: +44 1786 533 206; Email: zoe.pounce@roche.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Willing to comply with study procedures.

3. The participant must present as one of the following cohorts (primary presenting condition):

   • Cohort A - Embolism Cohort (participants presenting with symptoms indicative of thromboembolic events)
   • Cohort B - Infection or Inflammation Cohort (participants presenting with symptoms indicative of infection or inflammatory disorders)
   • Cohort C - Cardiovascular Cohort (participants presenting with symptoms indicative of heart failure or acute coronary syndrome)
   • Cohort D - Renal Cohort (participants presenting with symptoms indicative of renal disorders)
   • Cohort E - Oral Anticoagulation Cohort (participants with ongoing vitamin K antagonist therapy for at least four weeks)
   • Cohort F - Diabetes Cohort (participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2)
   • Cohort G - Lipid Cohort (participants presenting with symptoms indicative for Hypercholesterolemia )
   • Cohort H - Liver Cohort (participants with symptoms indicative of hepatic disorders).

Inclusion Criteria for Cohorts A, B, C, D, E, G, and H:

1. Participants ≥ 18 years of age

Inclusion Criteria for Cohort F (Diabetes Cohort):

1. Participants ≥ 16 years old

Exclusion Criteria:

1. Subjects deemed inappropriate for the study by the Principal Investigator.
2. Participants who have previously been enrolled in the EVOLVE study in the past 60 days.

Exclusion Criteria for Cohort E (Oral Anticoagulation Cohort):

1. Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.
2. Subjects who have anti-phospholipid antibody syndrome (APS)
3. The participant is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, experimental drug, or experimental device including either treatment or therapy.

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood clot; participants presenting with symptoms indicative of thromboembolic events	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Infection/Inflammation; participants presenting with symptoms indicative of infection or inflammatory disorders	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Heart disease; participants presenting with symptoms indicative of heart failure or acute coronary syndrome	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Kidney disease; participants presenting with symptoms indicative of renal disorders	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Blood thinners; participants with ongoing vitamin K antagonist therapy for at least four weeks	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Diabetes; participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
High cholesterol; participants presenting with symptoms indicative of Hypercholesterolemia	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Liver disease; participants with symptoms indicative of hepatic disorders	Diagnostic test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests; Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker concentration	Blood samples will be used to take a quantitative baseline measurement of 1 or more biomarkers associated with the following health conditions: Thromboembolism; Infection/Inflammation; Cardiovascular disease; Kidney disease; Vitamin K antagonist therapy; Diabetes; Hypercholesterolemia; Liver disease. Measurements are used for research, development and calibration of point-of-care diagnostic tests, and may compare results between different test methods. There is no statistical analysis planned on these measurements.	Baseline

Collaborators and Investigators

• Sponsor: LumiraDx UK Limited

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Embolism and Thrombosis; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Thrombosis; Inflammation; Heart Diseases; Diabetes Mellitus; Infections; Hypercholesterolemia; Liver Diseases; Kidney Diseases
• Other Study ID Numbers: RD007454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No