The US Food and Drug Administration (FDA) has approved a test developed by Israeli medtech firm MeMed that can rapidly determine whether an infection has been caused by a bacteria or a virus.
The MeMed BV test, which was developed by MeMed using a $30m grant from the EU and US Department of Defense, does not directly detect the cause of an infection.
Instead, it analyses three host response proteins – TRAIL, IP-10, and CRP – that show up in a patient’s blood at very different levels depending on whether the immune system is fighting off a virus or bacteria.
The test, which has received 501(k) clearance, delivers results in 15 minutes.
The clearance was based on a multi-centre blinded clinical validation study enrolling over 1,000 children and adults.
Doctors often prescribe antibiotics to patients presenting with symptoms like a cough or a fever in case they have a bacterial infection, but this can lead to massive overuse of these drugs, which in turn contributes to antimicrobial resistance (AMR).
AMR occurs when pathogens change over time and no longer respond to medicines, making infections harder to treat. This happens particularly quickly with bacteria compared to other pathogens like viruses.
The World Health Organization (WHO) lists AMR among the top ten global public health threats facing humanity and overuse of antibiotics is a key contributor to the problem.
Maimonides Medical Center professor of emergency medicine Sergey Motov said: “Host-response technologies are a new frontier in the management of adults with infectious diseases, with great potential to improve patient outcomes.
“Every day, I see patients with a complicated medical history presenting to the emergency room with a suspected respiratory tract infection. A technology like MeMed BV can significantly aid in their management.”
MeMed began offering an enzyme-linked immunosorbent assay (ELISA) version of the test in 2015 in the EU, Switzerland and Israel as part of an early access programme, and received CE-IVD marks for the BV test and Key platform last year. The company also has a licensing agreement with diagnostics firm DiaSorin, which gives the latter the right to commercialise the test for use on its Liaison analyser platform.
As a blood test, MeMed BV is particularly useful in cases where the site of the bacteria or virus is unknown or inaccessible, or the pathogen is undetectable using conventional methods.
Harvard Medical School professor of paediatrics and emergency medicine Rich Bachur said: “For those of us who care for acutely ill children, we have been waiting decades for accurate, rapid
diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness.
“This novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics.”