TAP 100 Touch Activated Phlebotomy device enters pivotal trial to provide painless diagnostic blood collection.- Seventh Sense Biosystems

Seventh Sense Biosystems, a privately held health technology company developing a breakthrough painless diagnostic blood collection platform, initiated a pivotal registration trial for its TAP Touch Activated Phlebotomy device. The company expects to file for marketing authorization in the United States and in the European Union in the second quarter of 2016, and anticipates receiving its E.U. CE Mark and U.S. regulatory approval later this summer. The trial involves 120 subjects at three hospitals in the Northeast U.S., and is expected to be completed in April. Seventh Sense expects to file its Premarket Notification with the U.S. Food and Drug Administration in May.

TAP is a proprietary platform that draws capillary blood in a painless, one-step process without having to puncture a vein or lance a fingertip. It can be utilized across a broad spectrum of diagnostic applications. The TAP system penetrates only the uppermost layers of skin using virtually invisible micro-needles, and collects capillary blood using a novel microfluidic extraction process. Blood is stabilized with an anticoagulant if required. The device has a visual indicator to confirm when collection is complete. The TAP platform is being developed to collect and transport blood for diagnostic testing using many of the top analytical platforms on the market.

Seventh Sense Biosystems, Inc., has obtained CE Mark approval for its Touch Activated Phlebotomy (TAP) platform for blood collection and testing in October 2013.