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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Shots: The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test  The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…

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