NEW YORK (360Dx) – RPS Diagnostics and Atomo Diagnostics announced today that they have entered into a commercial and developmental partnership to create FebriDx, a point-of-care test that identifies clinically significant underlying febrile acute respiratory infections and aids in the differentiation between viral and bacterial infections.
FebriDx uses a fingerstick blood sample to provide clinicians with a rapid assessment of the body's immune response to acute respiratory infections. The disposable test returns results within 10 minutes.
As part of the partnership, FebriDx test will now use Atomo Diagnostics' all-in-one rapid diagnostic test platform. Unlike other multicomponent rapid test kids, the Atomo platform consolidates the test procedure into a single device, the partners said. The platform includes an in-built safety lancet, a calibrated blood collection and delivery system, and an integrated push-button buffer delivery mechanism to prevent user-related errors and improve test performance. FebriDx can be performed easily by untrained healthcare providers, and the new partnership will support expansion of the product into resource-limited regions. In an interview last fall, RPS said it intends to make the test available in Europe and Canada in the second quarter of 2018.
It and Atomo added today that they have begun development of an enhanced digital, single-use, disposable version of the test, and US FDA clinical trials for the test are planned for the test.
FebriDx uses simultaneous detection of both Myxovirus resistance protein A, (MxA), and C-reactive protein, (CRP). 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.
More than half of all antibiotics are prescribed for acute respiratory infections, according to RPS. It is extremely difficult for physicians to differentiate between viral and bacterial causes for infection in an office visit, and diagnostic uncertainty and patient or parent pressures for antibiotic prescriptions lead to 50 percent of antibiotic prescriptions for acute respiratory infections being unnecessary, the companies said.
In a recent study in the United Kingdom, FebriDx was shown to alter clinical management decisions in 48 percent of patients tested, and to reduce unnecessary antibiotics by 80 percent.
"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," Robert Sambursy, president and chief technology and medical officer of RPS Diagnostics, said in a statement.