Babson Diagnostics Secures US FDA Nod For Blood Testing Service

Babson Diagnostics, a science-first health care technology business, announced that a key component of its BetterWay Blood Testing ecosystem has received FDA 510(k) clearance. These regulatory approvals open the way for Babson to launch BetterWay, the first-of-its-kind blood testing service, 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, as per pharmabiz

“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.”

BetterWay blood testing for primary care and family medicine was painstakingly created by Babson to assist yearly checkups, chronic condition management, and screenings. The launch menu is expected to include the most frequently ordered blood tests and to make use of current CPT codes to facilitate clinician-directed prescriptions and payer processing.

The FDA approval is also a significant milestone in Babson and BD's long-term strategic cooperation. Since 2016, the Babson team has been collaborating with BD on the development of BD MiniDraw.  BD will be a primary supplier to Babson with BD MiniDraw, and Babson will be a distributor for BD.