RPS Diagnostics Gets CE Mark for FebriDx Test

October 10, 2014

Sarasota, Fla., rapid point-of-care test maker RPS Diagnostics, said Thursday it has received a CE mark for its FebriDx, a rapid, disposable in-office diagnostic for pinpointing immune response to viral and bacterial acute febrile respiratory infections.

FebriDx combines analysis of myxovirus resistance protein A, which becomes elevated in the presence of acute viral infection, and C-reactive protein, an acute-phase protein that increases with bacterial infection. This helps differentiate between patients suffering from viral or bacterial acute febrile respiratory infections from those with other respiratory illnesses, the company says.

Patients provide a blood sample from a finger stick and get results in as little as 10 minutes, the company says, allowing the doctor to set a treatment plan during the patient’s initial visit.

Distinguishing between viral and bacterial infections can be challenging due to overlapping symptoms, RPS notes. Antibiotics are routinely prescribed to patients with acute respiratory infection, but are only effective against bacterial infections. Overuse of antibiotics is a major cause of drug-resistant bacteria.

The test will be available soon in all markets that observe the CE mark, RPS says. The company has not yet submitted FebriDx for FDA review. — Kellen Owings

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