The failures of Theranos were largely to do with managerial malpractice, secrecy and fraud, but the company first ran into difficulty on the scientific side, butting into the inherent difficulties of running reliable tests on tiny volumes of blood. Now Becton Dickinson, a big-cap medtech active in various segments, has allied with the much smaller microsampling specialist Babson Diagnostics to make pharmacy-based small-volume blood testing a reality.
“Theranos showed the world that there’s an appetite for new models and diagnostics,” Erik Allen, vice president, specimen management, at BD, tells Vantage. “There needs to be better access for patients and better collection methodologies.”
The deal will see BD develop a capillary blood sampling device to be used in pharmacies and other locations without trained phlebotomists. The blood samples taken using it will be sent to Babson’s Clia-certified laboratories for analysis, and the results returned the same day or the next, delivered simultaneously to the customer and their designated clinician.
The big question is how the groups will make this technology work. Capillary blood sampling has inherent problems; often it is difficult to obtain enough blood, and the process can cause haemolysis, where the blood cells, rupture, releasing intracellular molecules into the sample and confounding the results.
“There’s a process called milking where they will lance the finger and then the healthcare professional or phlebotomist will milk the finger – kind of squeeze it to get the blood out,” Mr Allen says. “Haemolysis is introduced by the squeezing in the milking process.”
The BD device will be able to harvest a useable quantity of blood without requiring the finger to be squeezed, Mr Allen says, guarding against haemolysis. He was unable to give details of the design of the product, saying these would emerge as the device got closer to regulatory approvals. The product is being tested at several retail sites in Texas.
It will be put through full clinical trials, Mr Allen says, with its accuracy being compared with other capillary-based tests as well as with tests that rely on traditional venepuncture. Trials are expected to start this year and read out in 2021.
The groups are also prioritising regulatory oversight; the trial data will be submitted to the FDA, probably in 2022, targeting 510(k) clearance for the blood-collection system.
“Transparency and the openness of the clinical data is extremely important,” Mr Allen says. “Openness of data as well as published results, in addition to the regulatory clearance, is important to establishing something as a standard.”
If the technology’s accuracy is good enough for clearance the partners foresee a variety of payment models. Babson is taking the lead on obtaining reimbursement wherever possible.
Some of the tests, which will initially include things like metabolic panels, thyroid function, lipids, haemoglobin A1c and blood counts, will be ordered by a physician, but some will simply be a result of individuals wishing to check up on aspects of their own health.
“Most insurance plans will require a clinician order before they will reimburse blood tests – this helps them ensure the tests they pay for are medically necessary,” Babson’s chief executive, Eric Olson, tells Vantage via email. “For the most part, self-ordered tests will be paid out of pocket by the customer.”
BD’s Mr Allen says reimbursed tests will be “the bigger opportunity”.
The shift into retail is a new move for BD. The company gets around 18% of its revenues from in vitro diagnostics, but these are generally ordered by doctors, with samples being taken in the doctor’s office or in a hospital. One exception is the Veritor system, device used in pharmacies and other locations that runs tests for flu, RSV and streptococcal infections. This is Clia waived and gives results in minutes while the patient waits – but the tests run on nasal swabs, not blood.
A reluctance to move completely into this foreign space is why BD has partnered with Babson rather than simply buying it. BD has not historically been a lab services provider, Mr Allen says, and is more comfortable with the service provision angle being taken care of by a separate company.
While the groups are certainly approaching this market much more sensibly than Theranos ever did, proving that reliable analyses can be run on a few drops of blood will not be easy.
The US market for blood testing is huge, with about $80bn worth of tests run each year, and Babson expects that as diagnostic technology develops, a significant fraction of this market will shift toward pharmacies and other convenient venues. But it is also highly competitive. Labcorp and Quest Diagnostics, among others, have established retail blood-testing businesses – the former in partnership with Walgreens and the latter with Safeway.
Still, patients’ demand for fast, convenient blood testing is not in doubt, and anything that keeps patients away from the expensive hospital environment will be looked on favourably by payers. If the new technology can permit a wider range of tests than can be done with current capillary systems BD and Babson could gain share. The trial data next year will be the first sign of whether this approach has legs.