The developer of a new roadside cannabis test is using the same eye movement technology behind its FDA-cleared device for rapidly diagnosing concussions.

Oculogica today announced its OcuPro device for detecting recent marijuana use and impairment. The headset device weighs less than 2 lb and is roughly the size of a large pair of binoculars, measuring around 8 in. long and wide and 3.25 in. tall.

The noninvasive test takes less than a minute to conduct and immediately offers results, which are stored on the device and uploaded to the cloud.

How the cannabis test works

The headset “measures dynamics of pupil size and movement with respect to each other in response to simple visual stimuli that varies in brightness and consists of images moving around a small screen,” the company said. “Pupil size and position measurements are used to calculate a ‘score’ that has been clinically validated in a large clinical study of 175 cannabis users compared with non-users to correlate with cannabis usage, and impairment due to cannabis use.”

Oculogica said the test does not replace a trained drug recognition expert or provide data that can be used as evidence. Rather, it can help establish probable cause like a field sobriety test and help an officer get a warrant for a blood test.

While the wearable device won’t need regulatory review from the FDA, Oculogica CEO Rosina Samadani told Medical Design & Outsourcing that her company might choose to later.

“We may pursue an indication for impairment and would discuss that with internal and external regulatory authorities before deciding on a pathway,” she said.

For now, the company is seeking volunteers to participate in a pilot program. Several police departments already intent to pilot the device, Samadani said.

Oculogica has been working on the project for more than two years. It’s the same team that worked on the portable concussion device, but the sales and marketing effort will diverge with the new product.

“The original suite of patents we licensed at company formation included patents for assessing substance abuse — with cannabis as one of those — with eye-tracking,” Samadani said. “We are approaching this from a physiological perspective, based on what is happening in the brain.”

“We’ve learned how to assess a device where the clinical reference standard is not established,” she later continued. “There is no gold-standard definition of concussion. There is no illegal level of cannabis in the blood, and there is no gold-standard definition of impairment. We excel at designing studies in those tough circumstances. We bring medical device clinical study expertise and rigor to this field, which is what’s needed. We find ourselves once again in a field where ‘ground truth’ is not necessarily well defined. We are, once again, very interested in helping establish ‘ground truth.'”