FDA clears 7SBio's 'virtually painless' blood collection device

The TAP device uses an array of microneedles and vacuum pressure to collect blood. Image: Seventh Sense Biosystems(7SBio)

Seventh Sense Biosystems (7SBio) picked up an FDA nod for its “push-button” blood collection device, specifically to test the HbA1c levels in patients with diabetes and prediabetes. The company plans to add more assays for use with the device.

The TAP device is a “virtually painless” alternative to traditional blood draws, which involve puncturing a vein with a long needle or lancing a fingertip.

Placed on the upper arm, it fires an array of microneedles into the skin, making tiny punctures. The pressure differential between the device’s interior and the skin causes the blood to be vacuumed into the device, 7SBio CEO Howard Weisman said. The sample is anticoagulated and stored in the device for transport to a lab.

“The needles are so small and are deployed and retracted so rapidly so patients don’t actually feel them compared to venipuncture,” Weisman said. This could cut down on the number of patients who delay or forgo doctor’s visits because of the blood draw, he said.

“No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90 percent of all diagnostic information coming from blood and its components,” Weisman said in the statement.

The company is in an “ongoing dialogue” with the FDA about additional assays for use with the TAP device. While it plans to keep submitting data for new indications to the FDA, labs that fall under CLIA may use the device for any test they wish, as long as they can validate that use, Weisman said.

7SBio will roll out the device in the coming months and envisions it to be useful in reference labs, retail pharmacies, athlete monitoring and clinical trials, in addition to hospitals and doctors’ offices.

And that’s not all—the company is planning to develop a version of the device that can be used to collect blood outside of traditional healthcare settings, including the home. The company reeled in $10 million last fall to develop new products around the TAP device and to ramp up its manufacturing capacity.