NEW YORK – Becton Dickinson and Babson Diagnostics are pulling together their expertise and resources in a bid to get retailers, including pharmacists, involved in the collection of capillary blood samples for testing.
While many blood collection processes involve venipunctures, the method requires a specially trained phlebotomist and centralized collection sites. To facilitate simpler capillary blood collection, Babson is leading the development of a system that could decentralize testing and reduce bottlenecks that result in long wait times, the firm's Founder and CEO Eric Olson said in an interview.
The process to implement the new system begins at sample collection and handling in a retail pharmacy. Actual testing would be done at a CLIA-certified laboratory, with results delivered to clinicians the same day or the next day.
The technology needed to conduct that process consists of three primary components, according to Babson and BD.
The first is the blood collection device being developed by BD for use in ambulatory settings such as retail pharmacies. It is designed to enable trained healthcare workers, such as pharmacists and pharmacy technicians, to draw a small volume of capillary blood from the fingertip with high enough quality to enable diagnostic results.
After drawing blood, the healthcare worker will deposit the sample into Babson’s proprietary sample handling machine, also in development, which is designed to fully automate preanalytical processes, such as separating serum from whole blood, and to preserve the sample’s high quality.
Babson’s daily courier service will transport the preserved samples to its CLIA-certified microsample laboratory for analysis using the third technological component, proprietary miniaturized assays developed by the firm. Easy-to-understand results will be sent directly to the customer and their clinicians the same day or the following day, Babson said.
Babson and BD announced a long-term partnership in February, and they are initiating clinical studies that they anticipate could eventually lead to their requesting marketing clearance from the US Food and Drug Administration.
Babson has started rolling out studies to validate the overall system at retail pharmacies in Austin, Texas, the location of its headquarters. However, the partners expect that development, validation, regulatory clearance, and product launch will take several years, Olson said.
Olson, who was head of the product portfolio for the central lab business at Siemens Healthineers prior to becoming Babson's founder, said he and his colleagues incubated the new firm at Siemens beginning in 2015, and took another two years developing initial products before launching Babson in 2017. The firm is independent from Siemens but executives at both companies continue to work together, Olson said.
He said Babson is developing the preanalytical and analytical technology to process the microsamples in its own high-throughput laboratory, but the firm believes that the overall system has broad applicability in blood testing, and Babson is exploring additional ways to grow its adoption, including the potential for its implementation in laboratories other than its own in the future.
The initial test menu at commercialization will include the routine and critical care tests that are in greatest demand at retail settings, and additional tests will be added over time, Olson said.
The model would enable laboratory quality testing with samples that consist of one-tenth the volume of blood drawn using venipuncture and would eliminate more than 90 percent of blood wasted during traditional venipuncture processes, he said.
Despite drawbacks, venipuncture — drawing blood from a vein in the arm — produces high enough quality samples to produce diagnostic results, and has been the main method for drawing blood samples for testing for decades.
Erik Allen, vice president and general manager at BD, said in an interview that his company's venous products add "value to the healthcare system in terms of delivering diagnostic accuracy and specimen integrity and quality." However, the company "wants to continue to drive innovation and if there's going to be a new testing methodology, we want BD to come up with it rather than another company," he said. "It's our job to continue to innovate and to drive new approaches in healthcare, particularly for something that's as essential as diagnostic testing."
The new blood collection system is expected to enable physician-ordered and self-ordered diagnostic blood tests at retail pharmacies, but it is also being designed for use in different healthcare settings such as physician offices, urgent care centers, and skilled nursing facilities, Allen said.
Babson is BD's exclusive strategic partner for retail use of the blood collection system, Allen said, but BD also thinks the system could be used in instances when blood can be collected at a patient's home.
"Just as [BD's] Vacutainer is what we and many clinicians consider the gold standard for venous blood testing, we would like our capillary collection device to become the standard for capillary collection in the future," he added.
Both Olson and Allen said they believe there is clearly a place for greater use of capillary blood collection, not only due to the opportunity for growth along with the increase in testing at retail and other settings, but also because venipuncture has its drawbacks.
For some, drawing venous blood can be physically and psychologically uncomfortable.
Large volumes of blood, typically between 4 mL and 10 mL, are drawn by phlebotomists trained specifically for that purpose, leading to centralized collection sites with large waiting rooms. These sites are often only open when most people are at work, they can have long wait times, and are often inconveniently located, creating barriers to accessing necessary preventive care, Babson said.
Capillary collection, decentralized to convenient retail settings, could help people access the blood tests they need, said Olson. However, the challenge to making that a reality, he said, is that current capillary collection presents broad obstacles to sample quality.
Slow collection causes excessive evaporation, gas exchange, and clotting, he said. Vacuum pressure and squeezing methods used to speed up collection can cause hemolysis, and the use of multiple needles to ensure enough blood is drawn can contaminate the sample with interstitial fluid and cellular material.
"BD’s capillary collection device, designed to mitigate all of these challenges, was an ideal fit for Babson’s blood testing service," Olson said.
Allen said that BD's collection device "significantly improves upon the patient experience" over current capillary testing processes, by making the squeezing process "simpler and easier so that it can be done by a person with a few minutes of training."
The system provides important improvements to mitigate other problems with current capillary sampling systems, including ensuring enough blood volume can be drawn for accurate testing and eliminating hemolysis, he said.
"Our approach… includes a brand new way to access the finger, collect the blood, and contain the blood," Allen said. However, the firm would not provide further details of the device design, and said it will await regulatory approval before doing so.
Blood collection may not be a sexy business that attracts a lot of attention, but several firms are working to improve upon existing technologies to draw the fluid from patients. Swedish start-up Capitainer, for example, recently closed $1.6 million in financing to support the commercialization of its dried-blood-spot sampling product, and Magnolia Medical Technologies recently received clearance from US regulators for its expanded Steripath Gen2 Initial Specimen Diversion Device line of blood contamination reduction products.
Last month, Kurin received FDA clearance for a collection system that uses a push-button needle.
BD sees the capillary collection technology that it is developing as an addition to its current portfolio of blood collection products, albeit an incremental market opportunity that could also compete with traditional venipuncture, Allen said.
"We believe that there is a large unfilled market of people who are not getting their tests filled because of the issues associated with convenience and access to a phlebotomist or outpatient center to collect blood," he added.
Babson and BD are also developing the technology in response to anticipated patient demand and the growth in testing at retail settings, Olson said.