The EU passes the first blood test to diagnose long Covid, despite UK patients waiting for UK regulator’s approval
- Studies have shown the test detects immune system cells specific to long Covid
- Brussels has awarded a CE mark to the incellKINE Long Covid In Vitro Diagnostic Test
- Patients from across the EU can take the test from early next month
- UK patients will have to wait for the UK regulator before the test is available
The first blood test for Long Covid has been approved by European regulators, raising hopes for the millions of Britons suffering from the debilitating disease.
Studies have shown the test detects immune system cells specific to long Covid, helping doctors distinguish it from other diseases with similar symptoms.
The incellKINE Long Covid in vitro diagnostic test has now received a CE mark, granting it approval for use in the European Union, after authorities accepted data from a study suggesting that it is safe across all strains of Covid was more than 90 percent accurate.
EU regulators have given approval for delivery of a Long Covid test starting next month
Long Covid prevalence is increasing in the UK and Europe – the World Health Organization estimates that up to one in five patients infected with the virus will experience a variety of medium and long-term effects after recovering from the original illness. Commonly reported symptoms include fatigue, shortness of breath, and brain fog
dr Stephanie de Giorgio, a Kent GP focused on tackling Long Covid, gives a cautious welcome to the test.
She says: “One of the problems that will remain is that we don’t have treatments. But if that proves effective, it might give people some answers as to why they’re feeling so bad.”
Its maker, IncellDx, plans to launch the test in Europe this month but will need to get approval from the UK regulator, the medicines and healthcare products regulator, before it can go on sale here.
Long Covid prevalence is increasing in the UK and Europe – the World Health Organization estimates that up to one in five patients infected with the virus will experience a variety of medium and long-term effects after recovering from the original illness.
Commonly reported symptoms include fatigue, shortness of breath, and brain fog.
Figures from the Office for National Statistics last week showed that an estimated two million people — about 3 percent of the population — reported problems lasting more than four weeks after initial infection.
Of those, 22 percent said their symptoms lasted at least two years. Despite this, the condition is poorly understood.
dr Bruce Patterson, CEO of California-based IncellDx, says, “Long Covid presents a significant diagnosis and treatment challenge.”
Many of the symptoms, which span a wide spectrum of cardiovascular issues, could easily be mistaken for painful conditions like post-treatment Lyme disease syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia, or even the common cold, he adds.
He adds: “Having an effective and objective tool to diagnose long Covid is absolutely essential.”
