-Paper Demonstrates Clinical Utility of TAP®
-Device Received FDA 510(k) Clearance in 2017
MEDFORD, Mass. -- Feb. 19, 2018 -- Seventh Sense Biosystems (7SBio) today announced a paper published in Nature Biomedical Engineering that compares the performance of the company's TAP® device to traditional venipuncture. TAP is a virtually painless, one-step blood collection device that uses microneedles to collect blood quickly and conveniently. TAP received U.S. Food and Drug Administration (FDA) 510(k) premarket clearance in 2017.
"TAP will make it possible to draw blood in many different settings. In the future, we envision people being able to quickly, safely and painlessly draw their own blood at home or at work and send a sample to be tested," Harry W Wilcox, CEO of 7SBio.
The new Nature Biomedical Engineering paper details the development of TAP and reports the results of a clinical study evaluating TAP for HbA1c determinations. Conducted at three hospital sites with over 140 patients, the study collected blood using TAP and venipuncture and then compared the results using two testing technologies, the DCA Vantage (Siemens) and the Afinion AS100 (Alere).
The authors found that samples collected from TAP were equally suitable for performing HbA1c determinations as samples collected via venipuncture. Importantly, the paper's authors also report that patients found blood collection with TAP significantly less painful than venipuncture.
"Everyone has become deeply accustomed to on-demand technology. As medical devices and other smart technology further integrate with daily health and fitness routines, we will continue to see healthcare become more convenient," said Bob Langer, Ph.D., 7SBio co-founder and one of 13 Institute Professors at the Massachusetts Institute of Technology (MIT's highest honor). "Technologies like TAP represent the future of how patients will interact with the healthcare system."
To read the full Nature Biomedical Engineering paper, please visit http://nature.com/articles/doi:10.1038/s41551-018-0194-1
About Seventh Sense
Seventh Sense Biosystems has designed and developed TAP, the world's first push-button blood collection device. It makes the process simple, convenient, and painless. $50 billion is spent annually on diagnostics and consumers are demanding more from the healthcare system. The company aims to create a new standard for blood collection that increases patient compliance with testing orders, leading to faster diagnoses and better outcomes. Future versions of TAP will be designed to enable patients to collect their own blood anywhere. 7SBio is funded by Flagship Pioneering and Polaris Partners, as well as Novartis ($NVS), Siemens ($SIEGn.DE), and LabCorp ($LH). The Company was founded by Flagship VentureLabs along with academics from MIT, executives from the pharmaceutical and diagnostic industries, and a former general counsel from the FDA. For more information: www.7sbio.com.