Point-of-care (POC) company Lumos Diagnostics has merged with commercial device developer and tests marketer RPS Diagnostics.
The combined entity will run as Lumos Diagnostics, which will initially focus on the international launch of FebriDx test for rapid analysis of the body’s immune response to an acute respiratory infection (ARI).
FebriDx is an in-office POC test with a built-in safety lancet for fingerstick blood samples, rotating blood collection and transfer system, and integrated push-button buffer activation.
The test is said to identify patients with a clinically significant underlying infection within ten minutes.
It also enables differentiation between viral and bacterial ARIs by simultaneously detecting proteins known to increase in the presence of an acute viral infection, and those that rise in case of clinically significant infection.
Lumos Diagnostics board chairman Sam Lanyon said: “We have evaluated many technologies over the years, and believe that combining RPS Diagnostics’ novel biomarker technology and commercial experience together with Lumos Diagnostics’ reader-based platform results in a highly strategic and synergistic union that will support a robust pipeline and commercial success.”
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When tested in two multi-centre clinical trials in the US, FebriDx demonstrated significant accuracy and 97%-99% negative predictive value to rule out a bacterial infection.
Rapid diagnosis at an initial office visit is expected to cut down unnecessary antibiotic prescriptions which could cause avoidable adverse reactions and antibiotic resistance, leading to lower costs.
An outcome study in the UK showed the test altered clinical management decisions in 48% of participants, while decreasing unnecessary antibiotic prescriptions by 80%.
RPS Diagnostics president and CEO Robert Sambursky said: “Using FebriDx to help triage outpatient ARI is a game changer because successful antibiotic stewardship requires the clinician to first rule out a clinically significant bacterial infection.
“In addition, access to novel Lumos Diagnostics reader technology will facilitate next generation digital enhancements which will accelerate speed to results, allow for quantitation, and enhance objectivity of our branded product lines.”
The merger of Lumos Diagnostics and RPS Diagnostics is expected to yield a full-service development firm.