Over 2 million people in the US have a synucleinopathy, and 100,000 are diagnosed every year. Many more patients go undiagnosed because there hasn’t been a simple clinical method available to make a diagnosis.

Clinical evaluation by a movement disorder specialist (for Parkinson’s disease and multiple system atrophy), a movement or cognitive disorder specialist (for dementia with Lewy bodies) or an autonomic expert (for pure autonomic failure and multiple system atrophy) can provide the most accurate diagnosis. However, the number of patients with synucleinopathies far exceeds the capacity of specialists, who often have long wait lists and are at great distances from the patients, putting significant strain on general neurologists or primary care doctors.

An additional challenge is that confirmatory testing is limited to techniques such as dopamine transporter imaging (DaTscan) and positron emission tomography (PET) which are costly, not widely available, and lack sensitivity and specificity. Further, as shown in the illustration below, patients may present with an array of clinical features that suggest different neurological disorders and overlapping symptoms can make it difficult to pinpoint a diagnosis.

A delay in diagnosis places significant physical and emotional strain on patients who are searching for answers about their health, and delayed treatment carries prognostic implications.

Consider the following use cases where the Syn-One Test can provide diagnostic clarity in determining whether a patient’s clinical features are indicative of a synucleinopathy:

• A patient’s essential tremor is not responding to treatment
• A patient presents with dementia but doesn’t fit cleanly into an Alzheimer’s disease phenotype
• A patient presents with autonomic dysfunction but has unexplained orthostatic hypotension
• A patient’s partner reports that he is acting out his dreams, but an overnight sleep study is too burdensome or expensive
• A patient presents with autonomic dysfunction, but it’s not clear if the underlying cause of symptoms is diabetes, idiopathic autonomic failure, or a synucleinopathy

The Syn-One Test offers a more sensitive, more specific, less expensive alternative to any other diagnostic available to clinicians and patients seeking to confirm a diagnosis of a synucleinopathy.