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.
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.
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.