Babson Diagnostics has announced that a key piece of its BetterWay Blood Testing ecosystem has achieved 510(k) clearance from the US Food and Drug Administration (FDA).
The regulatory clearances pave the way for Babson to bring BetterWay—a first-of-its-kind blood testing service—to market next year.
BetterWay aims to 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 service will enable blood testing by non-phlebotomists in convenient locations without sacrificing quality, accuracy, or the types of tests that are possible.
Babson Diagnostics CEO, David Stein, said: “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 healthcare 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 designed the BetterWay blood testing for primary care and family medicine, supporting annual exams, chronic condition management, and screenings.
The launch menu is expected to offer the most frequently ordered blood tests and use existing CPT codes to enable easy clinician-directed orders and processing by payers.
Babson founder and COO, Eric Olson, said: “BetterWay unites easy capillary blood collection and automated sample handling with the economies of scale and high quality of laboratory testing.
“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.”
