US-based privately held health technology company Seventh Sense Biosystems has commenced a registration trial for its TAP Touch Activated Phlebotomy device, which is a painless diagnostic blood collection platform.
The trial will involve 120 subjects across three hospitals in the Northeast US, and is expected to be completed this month.
Seventh Sense Biosystems CEO Howard Weisman said: "The start of our pivotal trial moves us closer to delivering this device to patients and physicians, ultimately enabling blood collection to be performed whenever and wherever it is needed, and by anyone.
"Our goal is to enable clinicians and patients to get vital health and disease status information more quickly."
TAP will cater to the requirement of an evolution in obtaining blood samples apart from the traditional needle insertion into a vein (venipuncture) or cutting a fingertip with a lancet (fingerstick), subsequently allowing blood collection in the retail and home settings.
The proprietary platform draws capillary blood in a painless, one-step process without puncturing a vein or lancing a fingertip and can be used across a range of diagnostic applications.
It penetrates the uppermost layers of skin using virtually invisible micro-needles, and collects capillary blood using a novel microfluidic extraction process.
The platform can stabilise blood by using an anticoagulant and is fitted with a visual indicator to indicate the completion of the procedure.
Weisman further added: "Blood collection for testing with TAP100 is convenient and painless, and its availability is intended to increase patient compliance with necessary test orders, providing doctors with more timely data on which to base diagnoses and treatment decisions."
The company is anticipated to seek authorisation to market the product in the US and in the European Union (EU) as well as seek the EU CE Mark and US regulatory approval in this year.
Image: The TAP100 Touch Activate Phlebotomy device. Photo: courtesy of PR Newswire Association LLC.