Welcome to today’s Biotech Spotlight, a series featuring companies that are creating breakthrough technologies and products. Today, we’re looking at Babson Diagnostics, which is developing a novel blood testing process that requires drops, not vials, of blood.
In focus with: David Stein, CEO, Babson Diagnostics
Babson Diagnostics’ vision: To deliver a less invasive, lower-cost and more convenient way to perform blood testing using a pea-sized sample taken from the patient’s finger at a local pharmacy.
“We're aiming to be a true replacement for venipuncture when it comes to broad wellness and routine testing,” Stein said.
Why it matters: “Blood testing is one of the most important things you can do to know about your biology and your health — 70% of clinical decisions are empowered by diagnostic blood testing,” said Stein. “Yet, 40% of people report they don't get ordered medical procedures and blood testing.”
Adding to the challenge, many people are fearful or even faint at the sight of needles.
“It’s not because they’re chicken or they’re being a baby. It’s a true physiological issue,” Stein said, adding that it can also take multiple attempts to find a vein, making routine tests highly unpleasant on top of the hassle of making the trip to the lab.
Babson Diagnostics, an Austin, Texas-based healthcare technology company, is looking to transform this process. Over the past several years it has pioneered a new model called BetterWay, which uses drops of capillary blood drawn from the finger, rather than a vial of blood from the arm. The sample is one-tenth the size of a traditional blood draw, and the results will cover the majority of routine tests ordered by doctors. This includes a complete blood count, a comprehensive metabolic panel, a lipid panel, vitamin D levels, thyroid stimulating hormone levels and a PSA test for men. One day, the company may expand into more specialty testing as well, Stein said.
In the shadow of Theranos
If the concept of a pin-prick blood test sounds familiar — it is. Theranos, a now-defunct company led by CEO Elizabeth Holmes defrauded investors with false promises of a finger prick blood testing technology that it ultimately couldn’t deliver. In the fallout to the debacle — which was one of the biggest scandals in biotech history — several company leaders were criminally charged. But the company’s plight illustrated that there is strong demand for a new blood testing option, Stein said.
At Theranos, the science behind the technology was shrouded in secrecy, but Babson is taking the opposite approach. It bills itself as “science-first,” and Stein said the company is eager to validate its technology in ongoing clinical trials and with the FDA. They’re aiming for the highest levels of clinical rigor.
“We’ve initiated over 37 IRB clinical studies (and) over 500,000 tests (in) over 3,000 subjects,” he said.
Babson isn’t working on this venture alone.
“We have the backing of the two most innovative health tech companies in the world in Becton, Dickinson and Company (BD)and Siemens Healthineers,” said Stein, who was the head of global strategy and innovation at Siemens before his move to Babson. BD is working with Babson on the blood collection device and Siemens on the lab side, he said.
"Blood testing is one of the most important things you can do to know about your biology and your health."
CEO, Babson Diagnostics
If the blood testing technology is approved, it might remove some of the barriers that keep people from following through on doctor-ordered blood tests. Babson’s testing process is designed to be convenient and quick. Insurance information is collected ahead of time, and depending on the location, patients can make an appointment or walk in and simply present a QR code at a nearby participating pharmacy. A staff member uses the Babson collection device to take the blood sample and then prepare it for the lab.
“That whole experience including collection, which is just done by a pharmacy tech or a trained healthcare worker is quick — less than 10 minutes,” Stein said, adding that the process is also private. The person collecting the sample doesn’t know what the test is for, and samples are transported by courier to one of the company’s highly automated micro-sample labs. Patients get results in one or two days.
It remains to be seen whether the industry and the public will embrace Babson’s approach if it is approved. But so far, Stein said they’ve had no trouble recruiting people for their clinical studies comparing their technology with traditional blood tests. He encourages more people to participate.
“We love when people do that because they can see the power of how we're doing it, and they can see the power of our results,” Stein said.