[Corrected 4/7/15, 1:00 p.m. See below.] Collecting a blood sample for lab testing can be a hassle and, for patients who fear needles, a scary proposition.
That’s something the leaders of Madison, WI-based startup Tasso want to help change with HemoLink, a small, cylindrical device that is designed to adhere to a patient’s arm or abdomen and almost painlessly draw the required blood from capillaries in the skin—instead of from a larger vein below the skin—in about two minutes. The vision for the device, which still needs to undergo further testing before Tasso seeks FDA clearance to sell it, is to allow patients to take blood samples at home and ship them to the lab. That would eliminate the inconvenience of visiting a clinic to have a trained phlebotomist do the blood draw, and it would take needles out of the equation, Tasso says.
The company, founded in 2012 by three biomedical engineers who studied at the University of Wisconsin-Madison, is still at least a year-and-a-half away from commercializing its device. But it has shown enough promise to win $5.3 million in federal grants. That includes a $2.9 million award announced today from the Defense Advanced Research Projects Agency (DARPA), an expansion of Tasso’s ongoing Phase 2 Small Business Innovation Research contract.
The new money includes a $1.3 million allocation to Tasso partner GenTegra, a Pleasanton, CA-based seller of products that help preserve samples of biological materials. The two companies are partnering to combine Tasso’s blood-draw device with technology from GenTegra that will stabilize biomarkers in the blood and allow it to be transported at ambient temperatures, without the ice packs normally required to preserve the samples for their journey to the lab.
Adding GenTegra’s technology to the HemoLink should lower the cost of shipping samples, Tasso co-founder and president Ben Moga says. That’s because the package would weigh less without the ice packs, and it wouldn’t have to be shipped overnight since the samples would be good “for at least 10 days,” he adds.
The product has applications both for individual patients conducting blood draws at home and for healthcare workers in the field. The technology “will enable connecting anyone in the world—from home, rural areas, low resource locations, or war zones—to a centralized blood analysis laboratory, providing affordable, cutting-edge diagnostics to everyone,” Erwin Berthier, Tasso co-founder and vice president of R&D and technology, says in a press release.
Tasso is part of a wave of companies trying to simplify the blood-testing process. Abaxis and Ativa Medical are among those who have developed devices for rapidly running blood tests right in the doctor’s office or clinic. Theranos, meanwhile, is developing lab tests that require much smaller volumes of blood than the typical blood draw. And Tasso has its hands full competing with better-funded companies like Cambridge, MA-based Seventh Sense Biosystems, which last year raised a $16 million Series B round to commercialize its simple blood-draw device.
“I think we’re in a growing industry; I think we’re in a changing industry,” Moga says. “That’s always good news for innovative technology.”
Tasso’s device is about the size of a short stack of poker chips, Moga says. The user sticks the adhesive side of it to the arm or abdomen, presses the red button on top of the device, and four tiny needles penetrate a couple of millimeters deep into the skin. Then, Tasso’s patent-pending microfluidics technology siphons the blood through the device and into an attached tube that gets filled with about 150 microliters in two minutes. That amount is more than 10 times the volume of blood drawn by pricking a finger for a glucose test, but it’s about one-tenth of what’s procured via a typical blood draw from an arm vein, Moga says. [An earlier version of this paragraph miscalculated the volume difference between HemoLink and a blood draw from an arm vein.]
In an early study with 16 patients, most people found Tasso’s device “comfortable,” Moga says. “Most subjects said they felt something, but it wasn’t pain.” Their tiny skin wounds healed within three days, he adds.
The company also built in a safeguard that keeps the needles from protruding again after the device has been activated once, he says. That reduces the potential for accidentally pricking someone else’s skin and exposing them to another person’s blood.
Tasso now plans to test the device on more than 100 people to compare it with other methods of blood collection. The goal is to prove that it draws enough blood to be useful for most diagnostic tests, and that there aren’t meaningful differences in the characteristics of blood taken from the skin’s capillaries versus larger veins under the skin, Moga says. “Is it a high-quality enough sample to get clinically relevant diagnostic results? We’re going to be testing that this year.”
The earliest Moga predicts Tasso’s device could win FDA clearance for sale in the U.S. is the end of 2016. The company has a number of important decisions to make before then, including whether it should raise money from investors and what its sales strategy should be, Moga says.
Tasso intends to initially sell the device to hospitals, outpatient clinics, and pharmacies, Moga says. It wouldn’t begin selling directly to consumers for at-home use until it gets FDA clearance to market the more advanced version of the HemoLink that integrates GenTegra’s sample preservation technology.
The two companies are about to roll up their sleeves on that project. The collaboration provides each side with technology it lacked before, GenTegra CEO Bruce Jamieson says. “I think it’s an ideal partnership because we provide the chemistry for stabilizing the molecules, but we have nothing for collecting the blood sample,” he says. “When you put the two together, it’s a really powerful combination.”
GenTegra was founded in 2013 after purchasing the former GenVault Corp.’s biomolecule stabilization products from IntegenX. The technology, Jamieson says, involves drying out biological samples and applying chemicals that defend against harmful enzymes, air, and water—three natural predators that degrade nucleic acids and other related molecules. GenTegra’s products seal off the desired molecules in a protective cocoon, similar to how dinosaur DNA has been preserved in fossils for millions of years, he says.
The design is still being worked out, Jamieson says, but the idea with the Tasso partnership is the inside of the HemoLink would be packed with tiny plastic beads coated with GenTegra’s protective chemicals. The blood would get dried out and preserved inside the HemoLink, then shipped to the lab, where water would get added to its contents to return the blood to liquid form, Jamieson says. “What you get back is essentially fresh, whole blood,” he adds. (Dry stabilization of liquid samples has been around for a number of years, and GenVault was a pioneer about a decade ago, Jamieson says. These days, GenTegra is competing against Biomatrica, for example.)
As part of the DARPA grant, GenTegra will attempt to prove that this process doesn’t damage the integrity of the blood and that researchers can still siphon off the biomarkers necessary for diagnostic tests, Jamieson says. “We’ve done some preliminary work, but we’ve got to prove it across more disease states, more biomarkers.”
And while GenTegra’s current products preserve just DNA and RNA, the new formulation for the Tasso device will try to preserve all of the enzymes, proteins, and other molecules found in blood “that are of interest to researchers or diagnosticians,” Jamieson says.
Tasso and GenTegra should have a working prototype and early proof-of-concept data by the end of next year, Moga says.