Dive Brief:

• Bethesda, Maryland-based eye-tracking technology developer RightEye received FDA's breakthrough device for its test for Parkinson's disease, the company said Tuesday.

• The diagnostic test is designed to detect ocular tremors associated with Parkinson's, giving physicians an objective way to detect signs of the disease at an early stage.

• The breakthrough device designation builds on RightEye's work to identify visual tracking impairments for a broader range of applications, which led to a 510(k) clearance last year.

Dive Insight:

Diagnosing Parkinson's, a progressive nervous system disorder, is difficult. In the absence of a single, definitive test, physicians pool results from a range of neurological examinations. RightEye stated in its announcement Tuesday that 60% of patients are misdiagnosed at least once and one-third of people are misdiagnosed twice.

Those statistics comes from a 2002 study but there is evidence that the problem they reveal remains. The authors of a 2018 study concluded "the overall quality of the clinical diagnosis ... is not optimal." Another researcher reached a similar conclusion two years earlier, pointing to a meta-analysis and a subsequent study of autopsy-verified cases of parkinsonism to argue "diagnosis is still unsatisfactory."

RightEye wants to give physicians a better, more objective way to judge whether a patient has the disease. The idea is to apply the RightEye Vision System to the detection of persistent ocular tremors, a symptom research suggests is pervasive in Parkinson’s patients and appears before other signs.

The concept of diagnosing Parkinson's based on ocular tremors was the subject of a study published in 2012, which found all 112 patients studied with the disease exhibited the symptom. However, some skeptics think the tremors may stem from head oscillations, pointing to the lack of evidence in other tests to call for more work to be done before the symptom is established as a Parkinson's biomarker.​

Having secured the breakthrough designation, RightEye is in a stronger position to demonstrate the value of tracking ocular tremors. The regulatory status positions RightEye to receive extra input from FDA and benefit from an expedited regulatory review. 

Other companies are trying to improve diagnosis of Parkinson’s by different means. In May, FDA granted breakthrough device designation to Amprion's test for detecting prion (a type of protein linked to neurodegenerative disorders) biomarkers. Amprion subsequently received funding from the National Institute on Aging to support work to adapt the test to the detection of Alzheimer's disease.