Blood tests? Aisle 3: FDA greenlights BD & Babson’s fingertip collection system aimed at pharmacies, grocery stores

December 7, 2023

By Conor Hale Fierce Biotech

Theranos had a lot of bad ideas, but making blood draws smaller and easier wasn’t necessarily one of them. A decade after the now-defunct blood-testing startup emerged from stealth, BD has now claimed an FDA clearance for fingerstick collection hardware that aims to bring the most common blood tests to pharmacies, grocery stores and other retail locations.

The green light marks a major milestone in the blood collection giant’s long-running collaboration with Babson Diagnostics, the Fierce Medtech Fierce 15 winner that’s been co-developing an effective capillary blood draw system with BD since 2016.

The fruit of their labors is the BD MiniDraw. The device only needs about one-tenth of the volume compared to a traditional blood sample siphoned from a vein, and it addresses what Babson describes as “the typical pitfalls of capillary collection”—namely, surface contamination and how the physical pressure of squeezing out the blood can ultimately hinder a test’s accuracy.

The FDA’s 510(k) clearance covers tests used to help diagnose conditions such as high cholesterol and hypertension, including lipid panels, chemistry assays and hemoglobin and hematocrit levels. BD said it plans to expand the MiniDraw to more uses in the future.

The process needs the hands of a trained healthcare provider but does not require a specialized phlebotomist—making it an option for doctor’s offices as well as other locations, such as urgent care centers and skilled nursing facilities.

“Because the BD MiniDraw Collection System enables blood collection at non-traditional sites that may be more convenient—like your local pharmacy rather than a standalone lab—we can expand health equity and access, and make it easier for patients to get the blood tests they need both for preventative care and the management of chronic conditions,” said BD’s life sciences president, Dave Hickey.

MiniDraw will also serve as the cornerstone of Babson’s upcoming BetterWay blood testing service for primary care and family medicine, slated to launch in 2024.

Using its pea-sized drops of blood, the company aims to offer a slate of tests including liver and kidney panels, as well as complete blood cell counts and more, all through its own automated laboratory.

“Blood testing has remained largely unchanged over the past 70 years, yet it is a critical component of the care journey,” said Babson CEO David Stein. “BetterWay will help address the ongoing shortage of healthcare professionals as well as the increasing need to expand access and reduce healthcare costs. Our mission is to deliver a better experience at convenient locations, with easy-to-understand, medically accurate results trusted by clinicians.”

About Babson Diagnostics

Babson Diagnostics is a science-first healthcare technology company reimagining the entire diagnostic blood testing experience. Babson’s mission is to make routine blood testing less invasive, more convenient, and affordable, empowering people to take charge of their health.

Babson is preparing for the commercial launch of BetterWay® blood testing, a first-of-its-kind ecosystem designed for primary care and family medicine, supporting annual exams, chronic condition management, and screenings.

BetterWay expands access to blood testing by using a unique device that requires only a pea-sized amount of blood collected from a fingertip. This next generation device created in partnership with Becton, Dickinson and Company (BD) enables trained healthcare professionals to collect high quality samples in convenient locations without the need for a phlebotomist. The BetterWay launch menu covers 80% of the most ordered tests and produces medically accurate results equivalent to traditional methods of blood testing that require much more sample volume.

The company holds exclusive, strategic partnerships with Siemens Healthineers and BD, and has received key patents in the United States, European Union, and China related to its unique end-to-end technological ecosystem and the ability to maximize the clinical utility of microsamples of blood collected from a fingertip. In addition, Babson has fully validated a broad set of miniaturized assays that are ready for commercial use in its CLIA-certified laboratory.

Babson, based in Austin, Texas, was founded by individuals with deep experience in healthcare, diagnostics, engineering, and laboratory technologies. It is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built.