This funding will support the international commercial expansion of the FebriDx rapid point-of-care test, the FebriDx US FDA pivotal clinical trial, and additional development and manufacturing resources for the company's expanding full-service POC business.
Lumos Diagnostics, a spinout from Planet Innovation, merged with RPS Diagnostics in May 2019, creating a diverse healthcare company that combines the FebriDx test and commercial experience with a novel and proprietary digital reader platform.
FebriDx is a rapid POC test that provides clinicians with an in-office assessment of the body's immune response to acute respiratory infection.
More than 50% of all unnecessary antibiotic prescriptions are for outpatient ARIs which may be associated with nonspecific flu-like symptoms, including fever, sore throat, cough, nasal congestion and fatigue. Only bacterial infections benefit from antibiotic treatment.
The single-use FebriDx test identifies patients of all ages within 10 minutes who 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 and C-reactive protein directly from a fingerstick blood sample.
MxA is highly specific and elevates in the presence of acute viral infection while CRP is a nonspecific inflammatory protein that elevates in the presence of clinically significant infection. The simultaneous, combined interpretation of both MxA and CRP leads to sensitive and specific test results.
With a 97-99% negative predictive value for ruling out bacterial infections, 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.
Lumos Diagnostics provides rapid, cost-effective and complete point-of-care diagnostic test solutions that utilize proprietary digital reader platforms to help healthcare professionals more accurately diagnose and manage diseases and medical conditions.
Lumos provides assay development and manufacturing services for customized POC tests as well as directly develops, manufactures and will commercialize a suite of proprietary Lumos-branded POC tests that focus on the systemic host immune response.
Lumos's tests target infectious and inflammatory diseases with unmet diagnostic needs.
Actionable results lead to less unnecessary treatments with associated adverse events, reduced spread of disease and more effective clinical management and therapeutic decisions.
The FebriDx test has received HealthCanada approval, Saudi Arabia FDA clearance, Singapore HSA registration, Pakistan DRAP registration and is CE marked for sale in Europe.
At this time, FebriDx has not received US Food and Drug Administration clearance and is not commercially available in the United States.
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