LAS VEGAS — A new and virtually painless way to draw blood for lab testing has the potential to replace the more than 400 million needle blood draws performed each year in the United States.
The Touch Activated Phlebotomy, or TAP, device, presented here at the Consumer Technology Association 2017 Digital Health Summit, could completely eliminate the need for tourniquets and needles.
"The process of obtaining blood samples hasn't changed in decades. A skilled health worker has to put a thick needle into you, which hurts, and patients don't like it," Stuart Blitz, chief business officer at Seventh Sense Biosystems (7SBio), told Medscape Medical News before he went on stage to demonstrate the new product. "It's outdated and quite barbaric."
With TAP, a healthcare provider places the device, which is about the size of a golf ball, on the patient's upper arm and then pushes a button, activating 30 thin needles that penetrate the uppermost layers of the skin. The resulting micropunctures do not hurt, according to presentation volunteer Mike Feibus, who is a tech columnist at USA Today and Fortune.
It takes about 2 minutes to suction 100 µL of blood from the patient's capillaries. "This device works kind of like a leech; you don't really feel anything," Blitz explained.
TAP solves the problem of extracting blood painlessly by doing it quickly, piercing the skin at a rate of 100,000 m/s².
"I've have had some bad experiences, when the nurse had trouble finding a vein and missed a few times," said Scott Sameroff, director of strategic business development for AccuWeather, who watched the demonstration. "When that happens, it's painful and unpleasant; there's obviously a ton of potential for this," he told Medscape Medical News.
FDA Approval
It is expected that the product will be launched in the next few months. The company has already responded to questions from the US Food and Drug Administration (FDA) and supplied clinical data. "We're in the final stage of approval," Blitz reported.
One of the studies provided to the FDA compared pain levels with three types of blood-collection methods. The data showed that the Wong-Baker pain score for fingerstick and venipuncture was 5, but for TAP it was 2, indicating that it is much less painful.
Another study looked at glycated hemoglobin (HbA1c) measurements in blood obtained with venipuncture or TAP in 240 samples from 22 healthcare-professional study participants, including nurses, phlebotomists, and medical assistants. In addition, sample extraction was evaluated by 20 participants, including laboratory technicians and medical technologists.
"The FDA was concerned about the possible differences in quality. Venous blood has no oxygen because it comes out through your veins; capillary blood has oxygen," Blitz explained.
For HbA1c measurements, agreement between venipuncture and TAP was excellent, at 98.7%, he pointed out.
Self-Administered Blood Collection Possible
After the FDA approves the TAP device for use by trained professionals, 7SBio plans to seek approval for use by patients, who could allow them collect their own blood anywhere.
The company also plans to enhance the capabilities of TAP by integrating a digital chip; this could dramatically change how blood is collected. For example, it could time-stamp a blood sample, which would be helpful when patients in remote areas have to mail their samples to a lab.
The device could also be used by people enrolled in clinical trials who need to supply blood samples. "We have an early prototype through our work with Qualcomm. It's a chip we can include that sends a Bluetooth signal when the device has been fired," Blitz told Medscape Medical News.
Eventually, digital integration could link the TAP device to laboratory diagnostic platforms that analyze blood samples. In the near future, Blitz explained, doctors will likely have access to mobile devices that can provide results in a matter of minutes.
The recent partnership between 7SBio and LabCorp, one of the country's largest testing laboratories, could accelerate the development of such technology.
Currently, all test labs in the United States are working on initiatives to conduct tests with less blood; the current large vials of blood are more than what is needed. "Our solution actually fits that," Blitz pointed out.
Mr Blitz is chief business officer of 7SBio. Mr Sameroff is director of strategic business development for AccuWeather.
Consumer Technology Association (CES) 2017 Digital Health Summit. Presented January 6, 2017.
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Cite this: Needleless, Pain-Free Blood-Draw Device Coming to Market - Medscape - Jan 10, 2017.
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