The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam.
Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease motor signs from the MDS-UPDRS Part III (motor examination) through a smartwatch (Verily’s Study Watch), according to the FDA letter.
The FDA determined that the examinations provided by Verily are “limited in their capacity to evaluate meaningful aspects of concepts of interest that are relevant to the patients’ ability to function in day-to-day life.”
In the letter, the FDA said a change in rigidity or finger tapping can’t be directly interpreted as meaningful to patients, while a change in speech, eating and dressing represents meaningful change. Further, the remote assessment providing an algorithmic representation of changes raised additional concerns with the FDA regarding the ability to interpret what are considered meaningful changes in a patient’s ability to function.
Examples of that included a lack of clarity in how the change in the digital signature for finger tapping could be interpreted as representing a meaningful change in function, according to the FDA.
“For these reasons, when evaluating drug efficacy in Parkinson’s disease, the FDA prefers content that is more representative of daily life functioning (e.g., consistent with the MDSUPDRS Part II or other similar instruments),” the FDA wrote.
Verily’s Study Watch is still on the market though, having garnered FDA clearance to include an irregular pulse monitor in January 2020, adding to an earlier clearance for ECG capabilities in January 2019.