Dr. Rob Sambursky, the President and CEO of Lumos Diagnostics is a very patient man. His brainchild, the FebriDx point of care system, can help providers distinguish between febrile respiratory infections caused by viruses from those caused by bacteria. It is presently in use in Canada, Europe, Pakistan, Singapore, and Australia, and currently in clinical trials for approval by the Food and Drug Administration for release in the United States. As Dr. Sambursky discusses in the video, the COVID-19 pandemic, has slowed enrollment in the clinical trials.
In the video Dr. Sambursky discusses the development of the FebriDx system, a journey that began, over 10 years ago. He is a ophthalmologist with additional training in infectious disease. He initially developed a product that could rapidly detect pathogens responsible for eye infections. This then led to an association with other researchers and eventually his interest in developing a rapid assay for Myxovirus resistance protein A (MxA), an interferon-induced dynamin-like GTPase , which is elevated in febrile respiratory infections.
The FebriDx test takes is completed in just 10 minutes, and is inexpensive (about $15). A finger is prepped with an alcohol wipe and dried, the lancet built into the device is activated and applied to the fingertip. A plastic tube draws up 5 microliters of finger stick blood which is then transferred to the cartridge mechanism. A button is pressed, releasing agents and a few minutes later, the device indicates whether the patient has elevated Myxovirus resistance protein A and/or CRP. An elevated CRP indicates bacterial respiratory infection, while an elevated Myxovirus resistance protein A with or without CRP indicated viral infection.
Dr. Sambursky discusses a variety of fascinating topics in the interview. First and foremost, when point of care PCR tests for identifying COVID-19 infected individuals are in short supply the FebriDX test may help identify those patients who should be prioritized for testing. Myxovirus resistance protein A is elevated in non-novel coronavirus infections, and one would expect that it would be elevated in patients infected with the novel coronavirus. Obviously Lumos Diagnostics will need to demonstrate to the satisfaction of the FDA that Myxovirus resistance protein A is elevated in COVID-19 infections. Once this has been established in a large cohort of patients, the FDA should consider fast tracking its release in the USA.
Pediatricians in the United States are already familiar with the CRP test and its utility in facilitating clinical decisions, but to date there are no Clia’88 waived POC CRP tests available. I can think of many potential scenarios where the FebriDx can be helpful – the child who is well appearing and has diffuse rales on lung exam, the crying child who has suspiciously red ears, the well appearing child with a mild sore throat who tests positive for strep and may be a carrier. We will need to wait until the device is available to decide on its usefulness in clinical practice.