Seventh Sense Biosystems’ TAP device
Good news for people that are afraid of needles and/or blood.
On Thursday the U.S. FDA cleared Seventh Sense Biosystem’s TAP phlebotomy device for use in hemoglobin A1c (HbA1c) testing, a standard parameter for diabetes management.
That’s the pilot test but there is a lot more to come, said Howard Weisman, CEO of the Boston, Massachusetts-based company.
The enclosed system acts as both needle and vial. Weisman hopes it will soon be approved for use without a trained specialist as well.
There is no real need for an expert. The device is placed on the upper arm. With a push of a button, an array of tiny microneedles pierces the skin. A vacuum chamber within the device then painlessly draws the blood from the pierced capillaries, where it is mixed with an anticoagulant. Two or three minutes later, TAP switches off, the patient gets on with their day and the device is sent to the laboratory for testing.
It’s seamless, but it’s also single-use. What happens when multiple vials need to be drawn?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“You could use multiple devices,” Weisman said, though he pointed out that the reason multiple vials are typically used is because different tests require different anticoagulants. It’s not about sample volumes.
“The instruments don’t require that much blood to do their analysis,” he explained. “That’s because the technology has advanced significantly in the last 40 years. But the blood collection process remains largely unchanged.”
In the future, Seventh Sense hopes to have a wide range of single-use tests on the market, categorized by the anticoagulant inside the chamber.
“At some point in the future, a TAP device may be all you need for a vast number of tests,” Weisman said. “But for today, we’ve been cleared for one and we’re working on others.”
With that in mind, can a single-use device be economically competitive?
Weisman declined to give a definitive price and said the products would initially be rolled out as a package offered to established partners in the space.
Longer-term, the company believes it can significantly reduce the cost of the procedure — especially when the cost of phlebotomists’ time is factored in.
“I’ll just give you an example of the value of something like this,” he said. “Today the cost of a blood draw if you have a professional phlebotomist would be somewhere in the order of $15.”
It may not always be a viable option, but if it helps improve a phlebotomist’s productivity or allows a patient to draw blood at a pharmacy or at home, there certainly is a space for the device within the healthcare system.
The company plans to launch TAP over the coming months, while also working to broaden its FDA clearance.
“We’re talking to the FDA about home use. We certainly want to be able to offer that in the future,” Weisman said. “It’s that simple.”
Those advantages will be needed. Innovation evidently deserted the blood collection space for a number of decades, but the race is now on.
In 2015, Velano Vascular gained market approval for its blood-draw technology, which is well-suited to the hospital setting. The device is now being scaled throughout the United States.
Photo: Seventh Sense Biosystems
