NEW YORK – Drawing on its longstanding partnership with Becton Dickinson, Babson Diagnostics is aiming to further expand use of its US Food and Drug Administration-cleared blood collection system across the US in 2025.
The company launched its fingertip blood collection device, which was codeveloped with BD, in pharmacies in its home city of Austin, Texas, last year and plans to expand to other cities in Texas and then throughout the US later this year. The device is currently available in pharmacies such as H-E-B Pharmacy, Peoples Rx, and Lake Hills Pharmacy.
When incubating Babson in 2015, its founders were aiming to create an alternative to traditional venous blood collection, which can often cause anxiety for patients and has a high rate of noncompliance, according to Babson CEO David Stein. Any alternative, however, would need to fit into the practice of medicine by offering essential tests that clinicians request from traditional laboratory testing. Additionally, the sample collection method would need to be financially viable and fit into the existing reimbursement framework for traditional testing.
For Stein, the company needed to provide a solution that "clinicians can use, patients can trust, and payors can reimburse."
Babson's end-to-end BetterWay testing ecosystem, which includes the BD MiniDraw Capillary Blood Collection device as well as Babson's proprietary automated sample preparation and pre-analytical processes, can be used in multiple healthcare settings, although it is most useful in non-acute care settings, Stein said.
BD is the legal manufacturer of the MiniDraw device, which received FDA clearance in 2023. BD also invested in Babson's last fundraising round, Stein said.
The blood collection device can be utilized anywhere, while the actual diagnostic testing occurs at Babson's CLIA-certified laboratory in Texas, leveraging Siemens Healthineers' Atellica analyzers, although Stein noted that the automated processes it uses could be used with other instruments. Babson has an exclusive agreement with Siemens that allows his firm to create its own laboratory-developed tests that miniaturize the amount of sample volume needed for high-volume instruments and run those tests on the Atellica platform.
The company's proprietary work focused on how best to miniaturize the amount of blood needed for routine laboratory tests and how to perform pre-analytic steps within the blood collection tube itself.
Stein noted that Babson's proprietary assays need 55 percent less sample volume than other traditional clinical chemistry tests. Much of the technology used to miniaturize the assays remains a trade secret, but the firm has broad patents that cover its sample preparation methods and technology, such as its method for reducing the amount of unusable sample left after collection and centrifugation.
The method uses a cap with a reservoir to separate serum or plasma from blood cells in a whole-blood sample. Blood cells are packed into the cap when the sample container is centrifuged, and when the cap is removed, a patient's serum or plasma is left in the specimen tube where it can be extracted by a pipette without leaving a large amount of unusable sample.
Use of the collection device requires some training, but the testing does not need to be performed by a phlebotomist, allowing it to be rolled out in pharmacies and other retail settings, Stein noted.
Babson conducted its Epsilon clinical study that evaluated 39 tests with both finger collection and venipuncture samples from 257 subjects to validate its system and found that its system meets established industry standards for analytical performance, including accuracy and precision.
Right now, the company offers a menu of 55 routine tests such as a complete blood count panel and a hepatic function panel, but it has plans to add a "significant number" of new tests in the next year, Stein said. Those expansions will include broadening its comprehensive panels, such as its thyroid panel and metabolic panel, and hormone testing.
The firm's tests are reimbursed through the US Centers for Medicare and Medicaid's Clinical Laboratory Fee Schedule, but for patients that choose to initiate their own testing without a clinician's order, Stein said the self-pay prices are "very affordable" and typically cost less than existing routine blood tests. A premium checkup that includes a variety of routine blood tests, including a comprehensive metabolic panel, a lipid panel, a renal function panel, and more, costs $258 on Babson's website. Individual tests range from $15 to $49 per test.
This year, the firm is preparing to announce additional retail locations where its testing will be made available and is working with large healthcare systems that have multiple clinics where its blood collection device could be used, such as urgent care clinics or doctors' offices. Babson will use BD's sales and marketing team to help form partnerships with those organizations and integrate the BetterWay testing system into their sites, Stein said.
He noted that customers aren't required to use the entire end-to-end system and that some customers may only use the front-end collection device and automated sample preparation to perform their own tests.
Babson also has plans to expand beyond the US, Stein noted, and the firm is seeing interest from potential partners in Europe, Latin America, and the Middle East and is open to partnerships for a variety of applications of its technology, he added.
While the company does compete with large reference laboratories like Quest Diagnostics and Laboratory Corporation of America, Stein said those labs could eventually be strong partners for Babson, potentially adopting the blood collection device or the sample preparation technology it uses.
Stein added that he sees one of Babson's "real strategic advantage[s]" as being able to encourage noncompliant patients who are hesitant to get routine venous blood testing done to get tested through the BetterWay system.