The designation recognizes the test’s potential to aid in the diagnosis of Alzheimer’s disease through a simple, non-invasive urine sample. Under the proposed indication recognized by the FDA, the test is intended to aid in the diagnosis of Alzheimer’s disease in adults aged 50 years and older who present with signs and symptoms of cognitive impairment and are undergoing evaluation for the condition. Test results are intended to be interpreted alongside other clinical information.

Matthew Laskowski, Founder and CEO of TOBY, stated that the designation validates the potential of urinary VOC patterns as an entirely new diagnostic modality. “Existing cleared and breakthrough-designated Alzheimer’s tests are generally focused on identifying amyloid pathology associated with Alzheimer’s disease, whereas the proposed indication for the TOBY Alzheimer’s Test is intended to aid in the diagnosis of Alzheimer’s disease itself,” he added.