Lumira EVOLVE

• Research type

  Research Study

• Full title

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

• IRAS ID

  359153

• Contact name

  Roy Gardner

• Contact email

  Roy.Gardner@glasgow.ac.uk

• Sponsor organisation

  Roche LumiraDx UK Ltd

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  The present clinical study is part of an industry effort to provide especially general practitioners with reliable blood tests on a portable, smaller instrument (cobas® lumira) to detect and treat various diseases listed in the following. The study will enrol approximately 30,000 individuals from hospital and clinical settings who will donate max 24 mL of blood, and have either a confirmed or suspected diagnosis of certain medical conditions.
  The new instrument allows blood testing with fingerstick blood, thus complementing current in-hospital standards to draw blood from a vein through a needle in the arm. The measurement in fingerstick blood represents a significant future simplification for both the physicians and patients especially in settings outside of the hospital. Therefore, the current project compares both blood types: blood drawn from the arm vein (current method) with fingerstick blood (complementary method). The proof of reliability of the new method will be used for health care regulators in Europe to show the reliability of the smaller instrument. This smaller instrument was developed entirely in the UK and will be manufactured in the future by Roche Diagnostics, a renowned global provider of blood testing services.
  The blood tests comprise the following medical conditions and circulating molecules (proteins, sugars and salt ions), while no genetic testing will be carried out with the samples:
  Cardiovascular / Cardiometabolic / Cardiorenal diseases: Albumin, BNP, CK-MB, Coagulation (INR), Creatine, Cystatin C, D-Dimer, Galectin-3, Glucose, HbA1c, Lipids, Myoglobin, Insulin (Endogenous), Insulin Analogues, Ketones, Maltose, NGAL, NT-proBNP, Pro-Insulin, Troponin, TSH, T4, Uric acid, Xylose
  Liver Diseases: ALT, AST, Bilirubin
  Infectious & inflammatory diseases: C-Peptide, CRP, PCT
  Other health conditions: Beta-hCG, Calcium, Chlorine, Potassium, Prolactin

• REC name

  West of Scotland REC 4

• REC reference

  25/WS/0166

• Date of REC Opinion

  14 Nov 2025

• REC opinion

  Unfavourable Opinion