August 21, 2024 | Theranos comparisons are generally not favorable, but Babson Diagnostics has now rolled out blood testing that achieves what Theranos claimed to: needle-free, small-volume blood testing, from the convenience of retail pharmacies.
Babson Diagnostics was born out of Siemens in 2017, launched by Siemens alum Eric Olson and partnering with BD (Becton, Dickinson) to build sample handling and analysis expertise paired with sample collection technology. Siemens Healthineers invested in both the company’s 2020 series A and 2021 series B funding rounds. BD and Babson renewed their long-term strategic partnership agreement in 2020 to bring laboratory-quality, small-volume blood collection to retail pharmacies. In the same year, David Stein, former CEO of Siemens' molecular diagnostics and point of care businesses, head of strategy for the diagnostics division, and global vice president of engineering within the diagnostics division, moved from the Babson Board of Directors to the CEO role. (Olson is now Chairman of the Board and COO.)
After a COVID-era stint in IgG antibody blood testing, the company returned to its core mission: small-volume blood testing made available directly to consumers. Last May, Babson Diagnostics launched BetterWay blood testing.
When speaking with Diagnostics World, Stein was eager to take on the Theranos comparisons. “We are a very different company from Theranos in many different ways,” Stein said. “We are diagnostics experts that want to make an industry we love better. For many of us at Babson, BetterWay is our life’s work,” Stein said.
Babson worked closely with diagnostics veterans BD and Siemens to develop the BetterWay offering, Stein emphasized. BD developed the collection device, the BD MiniDraw Collection System. The consumable device collects lab-quality blood samples from the patient fingertip with an embedded lance, without the need for phlebotomy. The system is FDA 510(k) cleared and uses only one-tenth the volume required for a traditional venous draw.
Siemens contributes its Atellica solution, a platform for chemistry and immunoassay tests exclusively licensed to Babson. The Atellica platform integrates analyzers with sample-management technology. “We have a partnership with Siemens where we were able to miniaturize the biochemical processes that actually do the blood testing,” Stein said. “That’s how we’re able to get more testing done with less blood volume.”
Clinical studies of the Babson approach and combination of platforms have been done, Stein said, estimating close to 50 internal IRB studies. None of these studies have—as yet—been published in peer reviewed journals, but Stein adds: “We actually show quite a bit of data right on our website.”
Consumer-Initiated Testing
While Theranos’ testing technology may have been smoke and nanotainers, the patient experience the company hit upon clearly struck a nerve and Babson followed suit.
BetterWay tests launched in May in Austin, Texas, the company’s home base. Testing is offered at retail pharmacies at H-E-B Pharmacy, Peoples Rx and Lake Hills Pharmacy—local chains that Stein describes as boutique pharmacies and a supermarket, all known locally for excellent customer service experiences.
The menu of tests available includes bundles—the “Essential Check-Up” bundle includes blood count, metabolic panel, A1C, and a lipid panel for $78—and individual panels or tests. A1C alone costs $19; the blood count panel alone costs $15.
“We cover the most ordered test panels,” Stein said. “We never collect more than two tubes [of blood],” he added. “You can order everything on our menu today, and we never collect more than a whole blood tube, which is used for the hematology test, the A1C, and a serum tube that’s used for all the metabolic panels and lipids and the immunoassays.”
Sample collection can be done by any Babson-trained pharmacy technician in a clinical room at the pharmacy without sharing any details about the ordered test types. Sample prep is done on Babson-supplied equipment. Couriers deliver samples to Babson’s Austin laboratory. Currently, two-thirds of patients get their results that evening, Stein reported; the rest—depending on when their samples were collected—receive results the next day.
Babson takes care of collecting payments—either billing insurance or patients pre-pay online—and returning results. There are both standard lab reports for doctors that order tests and “very detailed, customer-friendly lab reports” for consumers. “People love it because you could basically download a book about your health,” Stein said. Results are returned via the same channels through which tests were ordered. If a clinician faxed an order, a lab report is returned by fax. If an individual ordered a test via the Babson web portal, his consumer-focused results report would be available there.
Stein eschews the terms “direct-to-consumer” preferring “consumer-initiated” testing instead. A physician does “ensure medical necessity,” he said, will contact a patient, “if there’s an issue.”
“Our whole thing is how to make the transactional side super quick and super easy—for the patient and for the pharmacy,” Stein said. “You just want to show up, get it done, and go.”
Babson is taking, “a very measured approach” to rolling out the commercial launch, Stein said. The company has 11 public collection sites so far. Patients and clinicians are happy, he reports, and the company is seeing customers returning to order routine disease monitoring tests.
Next steps, he said, are expansion to San Antonio and other parts of Texas, a volume change Stein expects to Austin lab to easily handle. “What’s beautiful is Texas is a very large market.”