– Lumos Diagnostics raises $15M in Series A funding to support the international expansion of its point of care diagnostic solutions.
– 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 Diagnostics, a Sarasota, FL-based health IT company, today announced it has raised $15M in Series A funding from Planet Innovation, an Australia-based health tech innovation, and commercialization company.
Manufacture Custom Rapid Point-of-Care Diagnostic Solutions
Lumos Diagnostics, a spinout from Planet Innovation, merged with RPS Diagnostics in May 2019, provides rapid, cost-effective and complete point-of-care (POC) diagnostic test solutions that utilize proprietary digital reader platforms to help healthcare professionals more accurately diagnose and manage diseases and medical conditions.
Point-of-Care-Assays: Lumos manages the full development program for point-of-care (POC) assays, from sourcing and/or generation of reagents, right through to verification and validation. With the acquisition of Kestrel BioSciences, the Lumos team brings over 30 years of experience in lateral flow assay development and market knowledge.
Readers: The Lumos disposable reader platform has been designed for easy drop in of test strips and uploading of custom assay specific analysis algorithms.
Cloud & Data: Digital cloud platform to capture information on POC device location, test usage, results and associated patient metrics.
Manufacturing: World-class ISO 13485 certified OEM manufacturing facility, co-located with its technical R&D team to reduce the time and risk of transfer into production, and for ongoing support.
Funding Will Support International Commercial Expansion
The Series A funding will support the international commercial expansion of the FebriDx® rapid point-of-care (POC) test, the FebriDx U.S. FDA pivotal clinical trial, and additional development and manufacturing resources for the company’s expanding full-service POC business.
FebriDx Rapid POC Test
FebriDx is a rapid POC test that provides clinicians with an in-office assessment of the body’s immune response to acute respiratory infection (ARI). 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 (MxA) and C-reactive protein (CRP) 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.
Availability
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 U.S. Food and Drug Administration (FDA) clearance and is not commercially available in the United States.
“FebriDx helps advise antibiotic decisions for outpatient ARI while saving clinician time, improving workflow and reducing overall costs. The novel digital reader technology that Lumos offers as part of our complete POC service solution will be used in the next generation digital FebriDx test, providing faster time to results, identification of the rare co-infection and enhanced objectivity of test result interpretations,” said Robert Sambursky, MD, president and chief executive officer of Lumos Diagnostics.
