Seventh Sense Biosystems, Inc. (7SBio) announced that a new blood collection device called TAP has received US Food and Drug Administration (FDA) 510(k) clearance. The technology represents a landmark innovation in the blood collection industry where one billion blood draws are performed each year for diagnostic testing.

"No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90 per cent of all diagnostic information coming from blood and its components," said Howard Weisman, CEO of 7SBio. "TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere, making health monitoring much easier for both healthcare professionals and patients."

For decades, drawing blood has meant a healthcare professional inserts a long needle into a vein or lances a fingertip – both of which are laborious and painful. With TAP, people can experience a virtually painless, simple, and fast blood collection process. TAP is placed on the upper arm and blood collection starts with a simple press of a button – the process typically takes 2-3 minutes. Patients now don't need to fear getting a blood test and can comply with doctors' recommendations for routine testing.

The current clearance allows healthcare workers to use TAP to collect capillary blood for hemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or pre-diabetic patients. 7SBio is working with the FDA to expand the use of TAP to add additional tests, as well as "at home" collection.

There is a strong market need for this type of blood collection technology across numerous channels, such as reference labs, hospitals, retail pharmacies, doctors' offices, wellness screenings, molecular diagnostics testing, athlete monitoring, and clinical trials. In these settings, TAP can offer a more efficient blood collection method and a greatly improved patient experience.

7SBio's vision is to lead the "self-collection" movement – enabling consumer-friendly blood collection to occur at home, much like the "self-diagnostic" shift in the 1980's when patients could finally perform diagnostic tests at home. The company plans to develop and commercialize future versions of TAP that will enable consumers to collect their own blood anywhere and anytime.

"It's shocking that with all of the healthcare innovation we've seen in the past few decades, blood collection has lagged so far behind and is still a primitive and difficult process for so many people," said Robert Langer, 7SBio co-founder and one of 13 Institute Professors at MIT (MIT's highest honor). "I, and so many people I know, have always disliked needles, so it's exciting and fulfilling to receive FDA clearance after a terrific effort by our team. We had the opportunity to take our idea and create a device that fundamentally transforms the way blood is drawn — using microneedles smaller than an eyelash."

"We're thrilled to receive FDA clearance so patients can benefit from a much-improved experience and providers can streamline the blood collection process," added Weisman. "It's also just the beginning as we plan to expand our product offerings with the ultimate goal of making TAP the go-to tool for at-home blood collection."