The FebriDx test is a rapid, in-office point-of-care test that uses a fingerstick blood sample to provide clinicians with a rapid assessment of the body's immune response to ARIs. The single use, disposable test identifies within 10 minutes patients 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 c-reactive 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 a clinically significant infection.
"We are excited about our new partnership with Atomo Diagnostics," said Dr. Robert Sambursky, President and Chief Technology and Medical Officer of RPS Diagnostics. "We believe the incorporation of the novel Atomo technology into the existing FebriDx testing system will improve its ease of use and accuracy, allowing for broader acceptance in outpatient settings."
The commercially available, qualitative FebriDx test will now utilize Atomo Diagnostics' all-in-one rapid diagnostic test platform. Unlike standard, multi-component rapid test kits, the unique Atomo platform consolidates the test procedure into a single device. The platform incorporates an in-built safety lancet, calibrated blood collection and delivery system, and integrated push-button buffer delivery mechanism to help prevent user-related errors and improve test performance. FebriDx can be performed easily by untrained healthcare providers and this new partnership will support further expansion into resource limited regions.
Acute respiratory infections are often highly contagious and more than half of all antibiotics are prescribed for outpatients with these infections. ARIs may be associated with nonspecific flu-like symptoms including, fever, sore throat, cough, nasal congestion, and fatigue. Due to overlapping symptoms and signs, it is extremely challenging for physicians to differentiate between viral and bacterial causes of infection during an office visit. Both diagnostic uncertainty and patient or parent pressures for antibiotic prescriptions lead to 50% of antibiotic prescriptions for ARIs being unnecessary.
In a recent study in the United Kingdom, FebriDx was shown to alter clinical management decisions in 48% of patients tested, and to reduce unnecessary antibiotic prescriptions by 80%. By enabling a rapid diagnosis at the office visit, the FebriDx test can help to limit the amount of unnecessary antibiotic prescriptions that may lead to avoidable adverse reactions and antibiotic resistance, resulting in significantly lower costs.
"We believe that rapid viral versus bacterial differentiation is a critical need. We considered a variety of potential partnership opportunities in this area, and believe that FebriDx is the best positioned technology to achieve the greatest impact," said John Kelly, CEO of Atomo Diagnostics. "This exciting new partnership with RPS Diagnostics presents new opportunities for both parties and will further support Atomo's long-term expansion plans."
In addition, RPS and Atomo have commenced development of an enhanced digital single use, disposable version of the test. The digital FebriDx test is planned for U.S. FDA clinical trials.
RPS Diagnostics
RPS Diagnostics is an emerging biotechnology company strategically focused on designing, developing, and delivering novel point-of-care tests for infectious diseases and antibiotic stewardship. RPS Diagnostics is a trade name of Rapid Pathogen Screening, Inc., a wholly owned subsidiary of RPS Diagnostics, Inc. RPS products are developed using a unique, innovative, and patented technology platform that the company can utilize to develop a variety of cost-effective tests. RPS tests allow healthcare providers to more accurately diagnose diseases, provide appropriate and timely treatment, and reduce healthcare costs associated with spread of disease and unnecessary treatment methods. The FebriDx test has received HealthCanada approval, Saudi Arabia FDA clearance, Singapore HSA registration, and is CE marked for sale in Europe. At this time, the FebriDx test has not received U.S. FDA clearance and is not commercially available in the United States.
Atomo Diagnostics
Atomo Diagnostics is a world leader in medical device design and development, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specializes in developing innovative rapid diagnostic test (RDT) device platforms for capillary blood testing. Atomo's all-in-one devices put the end user first, and help to prevent user errors that are common with standard, multi-component RDT kits. The recipient of multiple international awards for design innovation, Atomo's device platforms make it easy to test and screen for a range of infectious diseases and chronic conditions. As well as commercializing products in its own brand, Atomo provides OEM product development services to specialist diagnostic companies worldwide.