The U.S. National Institutes of Health (NIH) has given a Small Business Innovation Research (SBIR) grant totaling $2.4 million to Cutaneous NeuroDiagnostics (CND) to advance development of its Syn-One Test for diagnosing Parkinson’s and other neurodegenerative diseases.
The SBIR grant (R44NS117214), which was awarded by the NIH’s National Institute of Neurological Disorders and Stroke, also will enable CND to launch a clinical study to validate preliminary results regarding the usefulness of the Syn-One Test. This study will enroll approximately 500 participants at testing sites led by neurologists and academic centers across the U.S.
“We are honored to receive this prestigious NIH grant. The award will support the largest study of its kind to enhance the precision and clinical utility of our Syn-One Test, which is being adopted by neurologists to improve the diagnosis of neurodegenerative disorders, notably Parkinson’s disease,” Todd Levine, MD, co-founder and chief medical officer of CND, said in a press release.
The Syn-One Test is designed to detect synucleopathies — conditions like Parkinson’s or Lewy body dementia, which are thought to be driven by the buildup of toxic aggregates of the protein alpha-synuclein inside nerve cells.
This test was developed out of a need for early detection of these conditions, which is challenging due to the lack of clear-cut evidence. According to CND, even experienced neurologists struggle to provide an accurate, early diagnosis of Parkinson’s in 30% of the cases.
As research into alpha-synuclein abnormalities has evolved the past decade, CND has leveraged these advancements to support the development of its Syn-One Test.
The test is minimally invasive, as it requires physicians only to collect three punch skin biopsies from a patient who has a suspected condition. A punch skin biopsy is performed using a circular tool that “punches” the skin’s surface to remove a portion of tissue containing all skin layers.
These samples are then sent to a lab, where investigators examine skin nerve fibers, while also looking for abnormal deposits of alpha-synuclein inside those fibers. CND then provides the test results, which include not only information regarding the presence of alpha-synuclein aggregates, but also images of the patient’s nerve fibers as evidence of the lab findings.
From 242 tests that already have been conducted in a preliminary analysis, the company reported the Syn-One Test achieved more than 95% sensitivity (correct positive diagnoses) and more than 99% specificity (correct negative diagnoses).
CND is aiming for widespread use of the Syn-One Test in the diagnosis of synucleopathies and neurodegenerative diseases. This quest prompted the company to apply for an NIH grant to support a clinical trial that would validate these preliminary findings.
The planned trial will include 300 patients with confirmed synucleopathies and 200 healthy subjects. Investigators processing the test results will be blinded from any information regarding participants’ clinical status.
“CND is determined to improve how physicians diagnose and treat patients with signs and symptoms of neurodegenerative diseases, especially early in the disease process,” said Richard Morello, CEO of CND.
“Advancing a convenient, minimally invasive test that can offer physicians and patients a higher degree of confidence and accuracy in the diagnosis of difficult diseases like Parkinson’s and dementia with Lewy bodies will help the field take a big step forward,” Morello added.
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