Rapid antigen tests (or lack thereof) have dominated the headlines for months now. Turning your kitchen counter into a mini pathology lab is now an essential ritual in determining if it’s the sniffles or the dreaded ‘c word’. 

Specialists in rapid point-of-care diagnostic technologies, Lumos Diagnostics (ASX: LDX) have been working on a useful test, FebriDx, to determine if illness is due to bacterial or viral infections. This is particularly handy for rapid screening of patients. 

The Company has just received regulatory approval to sell FebriDx in Brazil from the health regulatory agency, ANVISA.

Market authorisation allows Lumos to distribute FebriDx to healthcare professionals across Brazil, adding to their list of approved jurisdictions which include the UK, Europe, Canada, Australia and the UAE. 

An application for market approval in the US is under review with the FDA. An outcome is expected in the coming months.

Respiratory illness of both viral and bacterial origin can present with similar symptomatology. 

FebriDx works by analysing a single finger prick drop of blood within 10 minutes, allowing healthcare providers to determine if acute respiratory symptoms are caused by bacterial or viral infection. The test has shown 97-99% negative predictive value for bacterial infections, allowing doctors to eliminate bacterial infection as the cause of patient illness. This in turn leads to a reduction in the use of medically unnecessary antibiotics. 

Robert Sambursky, Lumos Diagnostics CEO said: “Historically, it has been difficult for doctors to determine if patients have viral or bacterial infections because the symptoms present nearly identical during a clinical exam. Using FebriDx, clinicians in Brazil can have actionable, lab-quality test results in about 10 minutes. This is a game-changer for diagnosing and managing acute respiratory infections in primary care and urgent care settings.”

A recent independent data analysis that looked at five separate clinical studies involving over 2,300 patients using FebriDx has now been published in the Journal of Hospital Infection, a peer-reviewed journal. The study clinically validates the test’s clinical value, especially when it comes to rapid screening of patients with suspected COVID-19. 

FebriDx and the Company’s rapid antigen test product, CoviDx both generated USD $1.1 million in sales revenue for the first half of FY22. The Company maintains a cash balance of USD $10.5 million as at 31st December 2021.