Gainesville, Florida-based etectRx has received FDA 510(k) clearance for its ID-Cap System, a prescription ingestible system that sends adherence event logs to an external medical device.

Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with stomach fluid.

However, the ID-Cap System’s receiving device does not need to be adhered to the user’s skin — as is the case for Proteus’ system — but can instead be worn on a lanyard. This receiver then forwards the adherence event data to secure provider web portal, by way of an intermediary patient smartphone app.

“The potential for ingestion adherence technology is best defined by the fact that various estimates place the cost of non-adherence at between $100 and $300 million per year in the US,” etectRx President and CEO Harry Travis told MobiHealthNews in an email. “We view our technology as a tool to be used to provide a very valuable piece of information to the clinician or researcher. That piece of information is to confirm that the patient actually ingested the prescribed medication. We will work with our potential partners to ensure that this piece of data fits smoothly into the larger clinical data landscape.”

etectRx submitted its application to the FDA in November of 2018, according to the agency’s 510(k) database, and was notified of the ID-Cap System’s clearance on Friday.

WHY IT MATTERS

With its regulatory clearance safely in hand, etectRx is now turning its attention toward “a broad array of partnerships that could include, pharma manufacturers, digital health companies, health plans, clinical research organizations and specialty pharmacies,” Travis said. “Our long term commercialization plans will be to work with all of the above organizations to help them achieve their goals of better patient outcomes or more accurate research outcomes.

The timing of the agency’s decision could hardly be more fortuitous for etectRx, as just this weekend news broke that Proteus had furloughed the majority of its employees after failing to close a $100 million funding round. The issue, according to anonymous sources, was that Proteus’ existing and potential business partners weren’t happy with the company’s limited effectiveness data for its FDA-cleared Abilify MyCite product — a development that could perhaps open new partnership doors for etectRx. On the other hand, etectRx will also have to deal with many of the same challenges that have plagued Proteus.

THE LARGER TREND

etectRx has a longtime clinical relationship with Brigham and Women’s Hospital and Fenway Health. These institutions are currently employing the company’s sensors in a study investigating adherence changes among those receiving Truvada pre-exposure prophylaxis (PrEP) for HIV prevention. This study is being funded by the drug’s manufacturer, Gilead Sciences, the NIH and etectRx.

Meanwhile, Proteus’ similar technology has been deployed in pilots and studies of patients with hepatitis C, tuberculosis, cardiometabolic syndrome and colorectal cancer, in addition to Abilify MyCite’s primary indication of schizophrenia.