US-FDA grants 510(k) clearance to Babson Diagnostics BetterWay Blood Testing ecosystem

Babson Diagnostics, a science-first, health care technology company, announced that a key piece of its BetterWay Blood Testing ecosystem has achieved 510(k) clearance from the US Food and Drug Administration. These regulatory clearances pave the way for Babson to bring BetterWay—a first-of-its-kind blood testing service—to market next year.

BetterWay will reimagine the entire blood testing process, using only a pea-sized amount of blood collected from a fingertip and delivering results equivalent to traditional blood testing methods. The BetterWay service will enable blood testing by non-phlebotomists in convenient locations without sacrificing quality, accuracy, or the types of tests that are possible.

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

Babson thoughtfully designed BetterWay blood testing for primary care and family medicine, supporting annual exams, chronic condition management, and screenings. The launch menu is anticipated to offer the most frequently ordered blood tests and use existing CPT codes to enable easy clinician-directed orders and processing by payers.

The FDA clearance also marks a pivotal milestone in the long-term strategic partnership between Babson and BD. The Babson team has been working with BD on the development of BD MiniDraw since 2016. With BD MiniDraw BD will be a key supplier to Babson, and Babson will serve as a distributor for BD.

Bringing blood testing services to more locations requires expanding the pool of professionals who can collect blood. The BetterWay blood testing service is designed for health care settings without a trained phlebotomist, such as retail pharmacies, physician offices, urgent care centers, and skilled nursing facilities. Health care workers can be trained to perform the BetterWay service and to collect a high-quality amount of blood from a finger using BD MiniDraw.

The sample preparation steps that occur between blood collection and arrival at the laboratory—labelling, mixing, centrifugation, storage, and transportation—are often the source of sample quality issues. Babson’s sample preparation device will automate pre-analytic processes and maintain optimal sample conditions. It is designed to reduce human interaction and error while maximizing quality. The sample preparation device makes metal storage boxes a thing of the past and seamlessly integrates into pharmacy operations.

Babson’s purpose-built, high-throughput lab uses market-leading analyzers adapted to produce high-quality results from capillary samples.

To date, Babson has validated the innovations in its ecosystem by conducting more than 30 IRB-approved clinical studies—many with local and national retail pharmacy teams—involving thousands of subjects and more than 700,000 tests.

“BetterWay unites easy capillary blood collection and automated sample handling with the economies of scale and high quality of laboratory testing,” said Eric Olson, founder and chief operating officer of Babson. “As a science-first company, we’ve taken a systematic approach to accomplish what others have only talked about. Now we are poised to launch a true diagnostic blood-testing alternative, meeting the stringent requirements of today’s clinicians and the expectations of the modern consumer.”

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.

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