Thursday, May 30, 2019
Lumos Diagnostics , a California-based diagnostics company offering comprehensive point-of-care (POC) services, and a former spin-off from the Australian company Planet Innovation , and RPS Diagnostics , a Florida-based commercial diagnostic developer that manufactures and distributes diagnostic tests to POCs, today announced their merger. The merged company will be called Lumos Diagnostics.
Lumos Diagnostics initially focused on the international launch of FebriDx®, a rapid office-based POC test that includes the following: an integrated safety lancet for finger-sampling a blood sample, sample collection system and rotational blood transfer, integrated transfer system and push-button activation. This allows clinicians to quickly assess the body's immune response to an acute respiratory infection (ARI). Disposable single-use test identifies patients with clinically significant underlying infection within 10 minutes and facilitates differentiation of viral and bacterial ARIs through rapid detection of myxovirus resistance to protein A (MxA) and protein C-reactive (CRP) from whole peripheral blood. MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute inflammatory protein that is elevated in the presence of a clinically significant infection.
Sam Lanyon, Chairman of Lumos Diagnostics, said, "We have evaluated many technologies over the years and believe that by combining innovative biomarker technology and RPS Diagnostics' business experience with Lumos Diagnostics' reading platform, we will foster a highly synergistic and strategic relationship that will lead to a strong pipeline and commercial success. "
Acute respiratory infections (ARI) are often highly contagious and cause more than half of all antibiotics prescribed during primary care visits and outpatient emergencies. AKI can be associated with non-specific flu-like symptoms, including fever, sore throat, cough, nasal congestion, and fatigue. Bacterial infections have the highest risk of morbidity and are the only ones to benefit from antibiotic treatment. Diagnostic uncertainty resulting from overlapping symptoms and signs of ARI, combined with patient or parent pressures to obtain antibiotics, has resulted in more than 50% of unnecessary prescriptions for antibiotics.
The clinical performance of two US multicenter prospective clinical trials demonstrates the high accuracy of the FebriDx test and its negative predictive value of 97-99% in ruling out a bacterial infection. In addition, a recent UK study found that FebriDx changed clinical management decisions for 48% of patients tested and reduced the number of unnecessary antibiotic prescriptions by 80%. By enabling rapid diagnosis at the first office visit, the FebriDx test can help limit the number of unnecessary antibiotic prescriptions that can lead to preventable adverse reactions and antibiotic resistance, which reduces costs.
Robert Sambursky, MD, CEO and CEO of RPS Diagnostics, who will retain the same role for the Lumos Diagnostics joint venture, says, "The use of FebriDx to help triage outpatient IRA patients is a game-changer because Effective antibiotic management requires first to rule out a clinically significant bacterial infection. In addition, access to Lumos Diagnostics' new reading technology will facilitate next generation digital enhancements, which will accelerate the speed of results, enable quantification, and enhance the objectivity of our branded product lines."
