03 Apr 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Seventh Sense Biosystems, a privately held medical device company developing integrated blood micro-collection and analysis platforms, has initiated a registration trial for its painless Touch Activated Phlebotomy (TAP) blood collection device.
The TAP system penetrates the uppermost layers of skin through the use of micro-needles, collects capillary blood using a novel microfluidic extraction process without having to access a vein and and stabilizes the blood with anticoagulant if required. The device also has a visual indicator to confirm that collection is complete.
The system can be utilized across and integrated with a broad spectrum of diagnostic applications. The company expects to file for marketing authorization in the US and in the European Union in the second quarter, and anticipates receiving its CE Mark and US regulatory approval later this year.
The company's proprietary TAP Blood Collection device is designed to address deficiencies in the current blood collection process, including patient anxiety that can negatively impact compliance with prescribed testing. The TAP platform is expected to offer greater efficiency over existing blood collection methods by providing a faster pathway to diagnostic results, while also increasing safety and eliminating pain.
Mr Howard Weisman, CEO, Seventh Sense Biosystems, said that, "We are excited to begin the registration trial with the company's lead product, the innovative TAP Blood Collection device. This confirmatory trial builds on previous human clinical testing that showed consistently affirmative results across an array of analytical methods."