Hart Biologicals is proud to announce the launch for a new product in a novel venture with international partner, Fiix Diagnostics.


The new product, known as the Fiix Test, is an innovative system for performing Prothrombin Time (PT) / International Normalised Ratio (INR) testing that simplifies results for medical professionals. 


The test was developed by Icelandic company, Fiix Diagnostics, which has appointed Hart Biologicals as its commercial partner as it starts to promote the use of the product throughout Europe and to other parts of the world.


Jack Doyle, Research Scientist for Hart Biologicals' sister company Hart Innovations, comments:


“Fiix Diagnostics came up with the theory of the test and now they’re aiming to make it a routine product which uses a special plasma preparation technique. The Fiix test uses a modified plasma, containing an ideal mixture of clotting factors. This mixture is designed to negate variation that comes about as a result of nutrition, exercise, or general lifestyle.


"A patient on warfarin, for example, needs to regularly have dose modifications with a physician. Depending on their lifestyle between meetings, this would change the dose of warfarin prescribed by a doctor. The Fiix test is capable of overcoming these variations in the test environment. This removes one of the patient-sensitive obstacles with INR monitoring.


"Fiix factor levels are balanced such that no matter how much of a swing there is in levels between meetings, it is so inconsequential to the mixture present in our plasma. This means that we can focus directly, and more accurately, on other factors directly sensitive to the VKA antithrombotic effect.


“This new form of test benefits patients in a way that means they will be required to attend fewer dosage alterations and will give a medical professional a better picture of the needs of their patients.” 


In a clinical trial performed by Fiix Diagnostics in Iceland, experts have found that the Fiix test has led to reduced INR variability and has safely reduced thromboembolism by half compared to a standard INR monitoring process. 


These results suggest that for patients on warfarin, the Fiix test can significantly improve clinical outcome due to reduced anticoagulation variability.


Each test kit will contain 5 x 1ml lyophilised Fiix plasma, 5 x 3.5ml PT reagent and 5 x 3.5ml Imidazole buffer.


Hart Biologicals will be showcasing the Fiix test throughout November and December at both Medica in Dusseldorf, Germany and the American Society of Hematology meeting in San Diego, USA.