New data from an independent study has confirmed that Proteus’ ingestible pill and sensor system has multiple benefits for those with tuberculosis.
The pill system study of 77 patients, conducted by the University of California, San Diego, Stanford University, HHS and Orange County Health Care Agency, found that it improved medication adherence and treatment for patients.
It found the system could accurately determine whether a patient had taken their medication, meaning at-home patients were more likely to keep up with their doses.
The study’s authors note, “This comparison of [wirelessly observed therapy (WOT)] and [directly observed therapy (DOT)] has policy implications for TB treatment within the US.”
“If recommendations for TB treatment require DOT dosing, based on our results, a WOT dose can be considered equivalent to a DOT dose.”
“Our findings provide rigorous data supporting WOT accuracy in clinical and home settings during the continuation phase of TB treatment.”
Results saw a positive detection accuracy rate of 99.3% for the wireless system.
The second part of the trial assigned 61 patients to either a WOT or DOT system.
Results showed a 93% adherence rate among WOT patients, compared to 63% in DOT patients. Further analysis which excluded weekends and public holidays found similar adherence rates for WOT and DOT, 95.6% versus 92.7% respectively.
The Gates Foundation is also funding $100M a year into a nonprofit biotech startup that will look to combat TB.
Before being randomized, all 61 patients confirmed they would prefer to use the ingestible system, resulting in the public health department requesting that all patients be permitted to continue using the system until their TB treatment was complete.
These adult TB patients taking isoniazid plus rifampin with no evidence of drug-resistant TB were selected from two public health treatment programs in Southern California.
The average age of the patients was 43; 42% were Asian, 39% were white, and 49% reported Hispanic ethnicity.
All patients first received a dose of medication under direct supervision, while wearing the WOT system.
The analysis collected a total of 1,073 person-days of data. The second part of the study assigned patients on a 2:1 basis to continue their treatment using the WOT system or five-days-a-week DOT.
Those using the Proteus system changed their patch each week unsupervised and tracked their progress on their smartphone. This yielded a total of 5,926 days of observation data for analysis as both arms lasted 16 weeks.
German-based GNA Biosolutions has also just closed a $13.5m Series C financing round. The company’s technology is used in more than 30 assays in-house and with partners, including assays for Hospital Acquired Infections and Tuberculosis.
TB kills more people each year than any other infectious disease, so reducing missed medication doses would greatly reduce the disease’s resurgence in treated patients, and reduce its spread in high-burden regions.