At ATH our goal is to contribute to a healthy Australia. We firmly believe that checking aspects of your health is key. Our innovative in vitro diagnostic (IVD) device is currently in the early production stages in order to produce units required to meet ISO 13485 accreditation requirements – achieved in September 2020 as well as conduct local trials as extensive international research that led to a patent being granted in China and the United States of America cannot be used locally. The device has been submitted for Australian Therapeutic Goods Administration (TGA) approval – in June 2021.
When commercially launched, the device will operate in a similar manner to urine-based home pregnancy tests. However, in this case, it will check for abnormal cell metabolism so that any early intervention that might be needed can be investigated further by a qualified medical professional. It works by having the person pour a sample of urine from the morning’s first visit into a container with the reagent that, when mixed with the urine, tests for the presence of above-average levels of particular Amino Acids (the building blocks for human cells) and metabolites. If the solution changes colour once mixed with the urine, it merely serves as an early warning that elevated levels of these Amino Acids or metabolites are present. Elevated levels of these amino acids and metabolites could be due to certain pharmaceuticals/supplements that you might have in your system or certain autoimmune disease (e.g. Lupus) or it could be some form of growth.
Therefore, if your test is positive (i.e. it has a distinctly red colour change) you should consult your General Practitioner so that they can assist and advise you on what further tests you should undertake in order to make a diagnosis. When used in conjunction with comprehensive blood analyses or laboratory-based Amino Acid Analysers, the test may indicate some abnormal cell activity, long before any symptoms present.
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