For many people a simple blood test is hardly a routine medical event if it involves a big needle. Some adults are squeamish to the point where they avoid giving a blood sample, while young children are often gripped by paroxysms of fear and crying.
Now a startup in Medford, Seventh Sense Biosystems, has developed a device the size of a walnut that it says will take the fear, pain, and inconvenience out of drawing blood. Attached to the patient’s arm with an adhesive strip, the device uses an array of tiny needles each about the size of an eyelash to quickly take a blood sample and leave almost no trace.
“I don’t really feel anything,” said Jessica Wakefield, a Seventh Sense employee who recently demonstrated how the device works. “It’s not pain.”
The device is called TAP100, and it uses a ring of 30 spring-loaded microneedles that puncture skin and withdraws 100 microliters of blood — enough for most common blood tests.
Seventh Sense chief executive Howard Weisman believes it could become a widespread replacement for the syringes and finger sticks that doctors currently use to draw most blood samples. Unlike needles and sticks, Weisman said, the TAP100 device is simple enough to use that patients could collect their own blood samples at home, and phlebotomists in medical offices would not have to fuss around finding a prominent vein.
Moreover, the increase in employee wellness programs has resulted in more blood screenings being done away from a medical setting.
Perhaps most importantly, it could lead to better care for the estimated 15 million Americans who have a phobia of needles, which research suggests causes them to delay or even skip important blood tests.
“Most people get a blood test because they grin and bear it,” Weisman said. “But if they could get that information in another way, they’d do it.”
The company has recently submitted the results of a trial on 120 patients at three hospitals in the Northeast to the US Food and Drug Administration. It said the results showed the device safely and consistently drew 100 microliters of blood each time. Seventh Sense hopes to receive clearance to sell TAP100 by the end of the summer.
Seventh Sense has raised $16 million to develop the device, which it manufactures in an on-site clean room at its Medford facility
Weisman declined to disclose a price for the device; a fingerstick kit at a chain pharmacy can run as much as $30.
Another startup, Theranos, has also developed a blood-testing method that it says is cheap and painless. The company raised hundreds of millions of dollars and signed a deal with pharmacy chain Walgreens, but its device has since been roundly questioned.
Theranos’s troubles aside, Weisman believes the health care industry is experiencing technology innovations that are transforming markets. Medicine, he said, will increasingly be characterized by decentralized, on-demand services that Seventh Sense can capitalize on by making blood collection easier.
“What Theranos demonstrated was that if you give a consumer an opportunity to have a test done on their own time, they’ll run to it,” Weisman said. “Even if their business plan didn’t work well, they demonstrated that not all tests need to be tethered to a hospital or a lab. Health care should be done wherever patients are.”
Accordingly, the design of the TAP100 was inspired by the aesthetics of companies like Google and Apple, he said.
Seventh Sense has some pretty high-profile names waiting to give TAP100 a wider testing. Novartis and the Laboratory Corporation of America, two of the largest companies in the blood diagnostics business, are each evaluating uses for the device.
“The TAP device shows strong promise as a blood specimen collection method for patients who are unable to have a traditional collection using a needle,” said Marcia Eisenberg, chief scientific officer at Laboratory Corporation of America, which invested in Seventh Sense in 2014.
Kent Lewandrowski, associate chief of pathology at Massachusetts General Hospital, said the concept is promising but stressed Seventh Sense will have to prove the efficacy of TAP100 in peer reviewed journals. Moreover the device will have to priced competitively, as the low-tech needle and finger sticks are also low cost.
“It offers a great deal of advantage over traditional phlebotomy,” said Lewandrowski, who was not involved in the development of TAP100. “It seems to be a very nice concept.”
Andrew Ellner, an assistant professor of medicine at Harvard Medical School who has followed the Theranos story, raised a more philosophical concern: giving patients better access to their own medical information doesn’t necessarily mean that they’ll be equipped to seek out appropriate treatment.
“If implemented in the right way, I think technologies like this can strengthen the relationships between patients and health care teams,” Ellner said of TAP100. “But the narrative that patients are just going to manage their own health — I don’t see that any time soon.”