Investigating the clinical utility of a novel oral fluid heart failure point-of-care test.

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Heart failure is common and carries a high mortality with around 40% of newly diagnosed patients dying each year in the UK. Although patients may complain of breathlessness, swollen legs and fatigue in the early stages, these symptoms are extremely non-specific, and 80% of cases are ultimately diagnosed in hospital.It is therefore critical that GPs and primary care teams are well equipped to make the diagnosis early and ensure timely medical intervention and specialist referral to a cardiologist. Whilst heart failure blood tests are already recommended by the National Institute for Health and Care Excellence for this purpose, up to one third of UK GPs still do not have access to the test. As a result, almost 200,000 patients each year in the UK are referred to secondary care based on signs and symptoms alone. Of these, two thirds will turn out not to have heart failure, costing the NHS more than £20 million of unnecessary annual expenditure.Meanwhile, although around a half of heart failure patients display symptoms that should trigger assessment in primary care, as many as 80% are diagnosed in the hospital emergency department in the context of a crisis. Once admitted, the additional associated financial burden amounts to more than £100 million due to long lengths of stay and poorer patient outcomes, much of which could be avoided.A new approach is clearly needed to save time and ensure efficient diagnosis for patients, but also to help GPs cut down consultation numbers and associated admin work and reduce the number of costly unnecessary referrals. A point-of-care test that could be performed in the surgery with an immediate result, that was inexpensive and non-invasive would allow GPs to rule in/out heart failure within the same consultation. Such a test would speed-up diagnosis massively, prevent unnecessary referrals and reduce hospitalisation rates with significant cost savings amounting to £110 per year.Biohabit Ltd is currently developing such non-invasive heart failure diagnostic test. The company has already demonstrated the proof-of-concept and is now starting clinical efficacy testing. Data and technical parameters generated in this project will allow the company to create a prototype of the proposed diagnostic device.Biohabit aims to sell the device to the NHS as well as health-conscious consumers, who will be able to purchase the test over-the-counter to assess the risk of developing heart failure and getting the upper hand in managing the cardiac health.