CEO SUMMARY: In Seattle, Tasso Inc., a start-up company, is developing a device that adheres to the skin and collects capillary blood that can be used for lab testing. Tasso says the device is a less invasive than a venipuncture. At the same time, executives at Tasso recognize that, for many types of lab tests, it has not yet been demonstrated that capillary blood is a comparable specimen to venous blood, which is the current gold standard for lab specimens. Under its current product development timetable, Tasso expects to file for FDA review of its new device in 2017.
ONE QUESTION RESEARCHERS WANT TO answer is whether clinical laboratories can use capillary blood rather than venous blood for certain tests. If they can use capillary blood, then the collection process becomes simpler and cheaper for labs and easier for consumers.
Recognizing these benefits, several companies are developing technologies to collect capillary blood in such a way that it can be reliably used for medical laboratory testing purposes.
Perhaps the best known company that claims to have technology that allows it to use capillary blood for much of its clinical laboratory testing is Theranos, the lab testing company based in Palo Alto, Calif.,
Also in this technology race is Tasso Inc., a start-up company in Seattle that uses a microfluidic blood-draw device called the HemoLink that it hopes can replace venipuncture.
Tasso President Ben Moga described the technology and the company’s plans to seek FDA approval for HemoLink. Developed by researchers at the University of Wisconsin-Madison, the blood-collection device is about the size of a golf ball.
To collect capillary blood, the HemoLink device is simply placed on a patient’s upper arm and left on the arm for two minutes. In that time, the device uses a lance and then draws blood from capillaries beneath the skin via a slight vacuum. Tasso’s proprietary open microfluidic network next transports the blood into an attached collection tube. Then the patient or physician can mail the tube to a medical laboratory for analysis.
Utility of Capillary Blood
“First, I should say that we use lancets in the HemoLink because there is no secret way to puncture the skin,” stated Moga. “We use the same mechanism everyone uses: a tiny lancet that pokes the skin.
“Second, there’s the issue of whether capillary blood is as useful as venous blood,” he continued. “Some people have speculated that interstitial fluid is an issue and it can be for some lab tests.
“But the larger issue for clinical labs is whether capillary blood can be compared with venous blood to produce substantially equivalent results from established lab test methodologies,” noted Moga. “For decades, venipuncture has been used and as a result it has become the de facto gold standard.
Capillary Blood Equivalency
“In recent years, many companies and research teams have been attempting to learn if capillary blood is equivalent to venous blood,” he explained. “Point-of-care instruments, for example, use finger sticks to assess A1c. So, we are not alone in asking this question.
“To answer this question, researchers have to go through the normal translational process for every new medical technology,” Moga added. “The technology gets vetted to ensure that clinical decisions can be made without errors.
“At Tasso, we are confident that, with the support of our partners, we will make inroads in demonstrating that capillary blood is substantially equivalent to venipuncture,” he said.
“Intuitively, we know that biomarkers of interest are present in both capillaries and veins and that they have slightly different properties or are present in different concentrations,” he said. “If we identify a biomarker that is not substantially equivalent between venous and capillary blood, then the next question is: can we provide a correction factor that would allow us to normalize the capillary blood so we can compare it to venous blood? This is the point we are at as we prepare for regulatory scrutiny.
“What makes the possibility of using capillary blood so exciting is that there are clear benefits for consumers given that collecting capillary blood via the HemoLink is less traumatic for patients,” noted Moga. “This is particularly true for pediatric patients, persons with hard-to-find veins, or those adults who have a history of fainting from a routine blood draw. And, given the density of nerve endings in the tips of our fingers, it is a fact that a finger stick hurts and therefore is particularly problematic for persons with a low pain threshold.
“Because the HemoLink technology has the potential to reduce pain and can be deployed in convenient locations, we are optimistic that it will appeal to consumers today who need or want to have blood drawn,” he explained. “Given the more active role that patients are playing in their healthcare-driven largely by increasing out-of-pocket payments-providers are thinking more and more of their patients as consumers. That is why all healthcare providers, including clinical labs, will continue to focus on the consumer’s experience.
“We believe that, by collecting blood in the least intrusive way possible and pro- viding samples that result in clinically relevant diagnostic data, the HemoLink will be a disruptive innovation,” Moga said.
“At Tasso, our goal is to develop and offer a safe, convenient, and affordable blood draw to the healthcare consumer,” he added. “We believe this will be a disruptive innovation for people who value or rely on diagnostic and clinical lab testing as part of their everyday lives.
“Much work remains to be done and a successful effort relies on the collaboration of an entire industry,” noted Moga. “With that in mind, we want to engineer a solution to make the blood collection front end to be as simple as possible.
“Given the current status of the lead product, our timeline is to submit an application to the FDA for approval in mid-2017,” concluded Moga. “The current goal is to obtain regulatory clearance in early 2018.”
Using New Technology to Streamline Workflow Involved in Collecting Clinical Lab Specimens
PICTURED HERE IS THE HEMOLINK DEVICE created by Tasso, Inc., to collect capillary blood for use in clinical laboratory testing and other diagnostic purposes.
HemoLink is designed to be simple to use and to allow patients at home to collect their own specimen. HemoLink is placed on the patient’s upper arm. In just two minutes, using lancets and a slight vacuum, the device draws blood from capillaries beneath the skin via a slight vacuum. Using microfluidics, that blood is transported into an attached collection tube. This tube can then be sent to a medical laboratory for analysis.
By designing a capillary blood collection device that can be used by patients at home to collect their own specimens, Tasso may make it possible for medical laboratories to re-engineer the traditional workflow of specimens collected at a patient service center, then transported by couriers to the core laboratory. The above diagram shows how Tasso believes use of its HemoLink device can eliminate two steps in the traditional specimen collection process.