Test to detect early Parkinson's given FDA Breakthrough Device Designation
The biotech company Amprion have developed a test to detect the early signs of Parkinson's, before the onset of symptoms, which they hope will be ready to market in the next 18 months.
The test, which detects changes in the alpha-synuclein protein in the blood or CSF, is to be fast-tracked through the development process in the US.
Need for early detection
There’s currently no definitive test for Parkinson's and no blood test or other biomarkers are available, making accurately measuring progression of the condition difficult.
As well as causing delays and misdiagnosis, these challenges could be holding back vital research into treatments that may one day be able to slow or stop the progression of Parkinson's.
Looking for clues
Alpha-synuclein has emerged as a promising candidate to be a Parkinson's biomarker. Researchers believe that this protein begins misfolding and aggregating into a toxic form before Parkinson's motor symptoms arise.
It’s hoped that if scientists can identify misfolded forms of alpha-synuclein early enough, it will open up opportunities to stop the toxic spread of the protein, and protect nerve cells from damage.
Amprion's test uses a technique that allows the researchers to detect even very low levels of misfolded alpha-synuclein in the blood and cerebral spinal fluid.
And now the test has been granted Breakthrough Device Designation by the US regulatory agency, the Food and Drug Administration (FDA). This programme is designed to speed up the development, assessment and review of medical devices for more effective treatment or diagnosis. Through the programme, Amprion predicts that the early detection test for Parkinson's will be ready for market roll-out within 18 months.
Dr Lynn Duffy, Senior Scientific Copy Writer at Parkinson's UK, said: "This is an exciting development in the search for a diagnostic biomarker for Parkinson's.
"If Amprion's test proves to be effective at identifying early Parkinson's, it could open up new treatment development avenues for stopping the condition in its tracks, or even prevent the onset of symptoms."