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 proprietary machine learning algorithms
- The Alzheimer’s designation expands TOBY’s portfolio beyond oncology & CNS diseases, with the company planning further clinical validation studies & continued collaboration with the US FDA on future regulatory submissions
Ref: PRnewswire | Image: TOBY | Press Release
Related News: TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test
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