4th June 2019 Content supplied by: RPC Diagnostics Systems
Lumos Diagnostics and RPS Diagnostics Merge - Initial Focus Will Be POC for ARI
Lumos Diagnostics and RPS Diagnostics have merged to become Lumos Diagnostics. Lumos Diagnostics’ initial focus is on the international launch of the FebriDx® test, a rapid, inoffice POC test that incorporates a built-in safety lancet to obtain a fingerstick blood sample, rotating blood collection and transfer system, and integrated push-button buffer activation, to provide clinicians with a rapid assessment of the body’s immune response to an acute respiratory infection (ARI).
The single use test identifies patients within 10 minutes that have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the simultaneous detection of both Myxovirus resistance protein A (MxA) and Creactive protein (CRP) directly from peripheral whole blood.
MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute-phase inflammatory protein that is elevated in the presence of clinically significant infection.
ARIs may be associated with nonspecific flu-like symptoms, including fever, sore throat, cough, nasal congestion, and fatigue. Bacterial infections pose the highest risk of morbidity and are the only infections that benefit from antibiotic treatment. Diagnostic uncertainty from overlapping ARI symptoms and signs combined with patient or parent pressures for antibiotic prescriptions lead to more than 50% of all unnecessary antibiotic prescriptions. Rapid single pathogen tests, such as for Strep A and Influenza, cannot differentiate colonization from true infection and are indicated for only specific respiratory conditions, accounting for about 15% and 25% of patient visits, respectively; whereas the majority of the patients have other viral infections, bacterial infections, or a microbiologically unconfirmed respiratory illness.
Clinical performance from two prospective multi-center U.S. clinical trials demonstrate the FebriDx test’s high accuracy and 97-99% negative predictive value to exclude a bacterial infection. Moreover, in a small United Kingdom outcome study, FebriDx was shown to alter clinical management decisions in 48% of patients tested and reduced unnecessary antibiotic prescriptions by 80%. By enabling a rapid diagnosis at the initial office visit, the FebriDx test may help to limit the amount of unnecessary antibiotic prescriptions that can lead to avoidable adverse reactions and antibiotic resistance, resulting in lower costs.
Date Published: 4th June 2019
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