Syn-One Test is an anatomic pathology assay that uses a minimally invasive 15-minute procedure. Credit: Shameer Pk from Pixabay.

CND Life Sciences has announced that its Syn-One Test was able to identify the pathological form of alpha-synuclein in the skin of more than 95% of patients diagnosed with synucleinopathy in the Synuclein-One study.

Synucleinopathies are a group of disorders with worsening neurological deficits. Patients with synucleinopathies are diagnosed with conditions such as Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies and pure autonomic failure.

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CND Life Sciences chief medical officer and principal investigator Dr Todd Levine said: “These results validate cutaneous alpha-synuclein as a reliable biomarker for Parkinson’s disease and related disorders, allowing us to offer the Syn-One Test as an accessible, patient-friendly diagnostic solution for clinical practice and an important technology for biopharmaceutical trials targeting alpha-synuclein.”

The prospective, multicentre and 428-participant Synuclein-One study showed that the Syn-One Test has 95.5% sensitivity in identifying phosphorylated alpha-synuclein among individuals diagnosed with synucleinopathy.

The sensitivity among Parkinson’s disease patients was found to be 92.7% while it was 100% for those with pure autonomic failure. The test demonstrated 96.7% specificity among 120 healthy volunteers. 

Funded by the National Institutes of Health, the trial involved 30 sites.

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Syn-One Test, an anatomic pathology assay, enables the diagnosis of patients exhibiting clinical characteristics that indicate the presence of a synucleinopathy, with Parkinson’s disease being the most observed among these conditions.

The test assesses three minor skin biopsies obtained from the patient in a physician’s office using a minimally invasive procedure that lasts 15 minutes.

It focuses on the evaluation of intraepidermal nerve fibre density and other significant pathological analyses in the skin.