
ATH (Australia) Pty Limited have developed what we believe is a global first urine self-test kit that identifies the presence of elevated concentrations of targeted amino acids and their metabolites in a fresh urine sample. The discrete urinary metabolic signatures created by elevated concentrations of these amino acids and their metabolites have been recognised in independent studies as attractive biomarkers or indicators for unusual cell metabolism in the human body – indicative of, amongst other things developing tumours.
In short, overseas the company can say it detects cancer cells. In Australia, due to strict regulatory requirements enforced by the TGA, the companies promotional material can only say it identifies unusual cell metabolism in the human body.
Since unusual cell metabolism is generally asymptomatic, the self-test kit can potentially indicate unusual cell metabolism before any symptoms present. The test kit is as simple to use as a home pregnancy test and will provide an early warning indication. However, users will be directed to schedule an appointment with their doctor as any actual diagnosis and subsequent therapy decisions can only be made by a medical professional.
ATH’s innovative in vitro diagnostic (IVD) device is currently in the early production stages in order to produce units required to maintain ISO 13485 accreditation requirements – achieved in September 2020 as well as conduct local trials as extensive international research that saw patents being granted in China, Macau, the United States of America and Australia. The company has submitted the device for Australian Therapeutic Goods Administration (TGA) approval
You can learn more about the company and the device that is branded as MyCellHealth here: https://athhealth.com
