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Digital Medicine System has the potential to provide clinicians with a new tool to track and manage adherence for HIV prevention therapy

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GAINESVILLE - etectRx, a privately held digital health company, is pleased to announce that its ID-Cap System, featuring state-of-the-art ingestion event monitoring technology, has been selected for a new study to observe adherence for the HIV prevention drug TRUVADA (tenofovir/emtricitabine) for PrEP^® (Pre-Exposure Prophylaxis).

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The study will be conducted at Brigham and Women's Hospital in Boston and in partnership with The Fenway Institute at Fenway Health, one of the preeminent LGBT health and HIV research organizations in the world. The manufacturer of TRUVADA for PrEP, Gilead Sciences, is funding the study, led by principal investigator, Dr. Peter Chai, M.D., M.M.S., toxicologist in the Department of Emergency Medicine at Brigham and Women's Hospital; and Assistant Professor, Harvard Medical School. The purpose of the study is to examine medication adherence patterns and understand how adherence can be increased among populations at risk for HIV infection.

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"Improved medication adherence is an essential strategy for ending the spread of HIV," said Kenneth H. Mayer, M.D., medical director and co-chair of The Fenway Institute at Fenway Health. "We are enthusiastically supporting Dr. Chai's research in this area and looking forward to seeing the results."

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etectRx's ID-Cap System is an ingestible event marker that utilizes proprietary, in vivo communications technology between an ingestible sensor and an external, wearable reader. The system is comprised of the ID-Capsule, ID-Tag, ID-Cap Reader and related software which allows data to be displayed for the patient and clinician. The ID-Capsule is a standard pharmaceutical capsule shell containing the ID-Tag, an ingestible sensor that emits a very low power radio frequency (RF) digital message from within the patient to the ID-Cap Reader, a wearable device which verifies the message as a valid ingestion event and forwards the data using Bluetooth technology to secure data display systems utilized by clinicians and patients.

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TRUVADA for PrEP is a prescription medicine that can help reduce the risk of contracting HIV-1 through sex, when taken every day for people who are currently HIV-negative and at risk of contracting HIV-1. In clinical studies, TRUVADA for PrEP has been shown to decrease the chance of HIV infection by close to 100 percent when users are adherent and is recommended by the Centers for Disease Control and Prevention when taken every day as one part of a complete HIV prevention plan. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence*.

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The participants in the study currently receive care at Fenway Health and will use the ID-Cap System for 90 days.

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"We are honored that these world-class institutions have selected etectRx's ID-Cap technology to aid in the study of this life-changing prevention therapy," said Harry J. Travis, president and CEO of etectRx. "We look forward to assessing the impact that the ID-Cap System can have on the lives of people at risk of contracting HIV."

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etectRx submitted a premarket notification (510(k)) application with the U.S. Food and Drug Administration (FDA) for its ID-Cap System as an ingestible event marker in late 2018 and anticipates FDA clearance for marketing this year. The ID-Cap System is currently only available for investigational use in IRB-approved clinical studies.