Rapid test to distinguish bacterial and viral infections wins US approval
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US regulators have approved the first test that distinguishes rapidly and reliably between bacterial and viral infections, helping doctors to avoid unnecessary prescriptions that are fuelling global antibiotic resistance.
The MeMed BV test, developed by the Israeli biotech company MeMed with $30m grant funding from the EU and US Department of Defense, does not directly detect the cause of an infection. Instead it analyses the “host response” — the different ways that the human immune system responds to bacteria and viruses.
“It’s a game-changer,” said Louis Bont, professor of paediatric immunity and infectious disease at Utrecht’s University Medical Centre in the Netherlands, who led a clinical evaluation of the test during its development.
His hospital has been using the test for three months. “When children come in with a cough, we can for the first time discover accurately whether they have a bacterial infection, in which case we give them an antibiotic, or a viral infection, when we don’t,” Bont said. Results appear within 15 minutes.
At the moment, doctors often give antibiotics to patients who present with a cough and a temperature, in case they have a bacterial infection, Bont said, “which leads to massive overuse of antibiotics.”
MeMed started life in 2009 when co-founders Eran Eden and Kfir Oved started experimenting in Oved’s grandmother’s kitchen with diagnostics based on human immune responses to infection.
Since then, they have attracted investment totalling $100m from companies including Social Capital and Western Technology Investment in California, Phoenix Insurance and Caesarea Medical Holdings in Israel, and Horizons Ventures in Hong Kong. An IPO may be on the horizon in the medium term, “not in a few months nor in many years — maybe 24 months”, said Eden, who is chief executive.
The company has some 100 full-time employees and is expanding its US operations from a base in Boston. “We are also establishing a UK headquarters,” Eden added.
The BV test — carried out on the company’s MeMed Key diagnostic machine — measures the levels of three proteins that show up in a patient’s blood at very different levels depending on whether the immune system is fighting a virus or bacteria. The results are particularly useful when the infection site is unknown or inaccessible, making it impossible to carry out conventional tests and take tissue samples.
The cost of each test will be in the region of $100 during the first commercial rollout. “We’re starting initially in hospital emergency departments but we’ll move on to more decentralised sales, including family doctors,” Eden said.
“I think it’s going to find its way into primary care quite quickly,” Bont predicted.
Rich Bachur, professor of paediatrics and emergency medicine at Harvard Medical School, is also enthusiastic. “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 recognisable viral illness,” he said. “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.”