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BD, Babson Get FDA Clearances for Fingertip Blood Collection Device for Use With Certain Lab Tests

NEW YORK – Becton Dickinson announced on Thursday that it has received US Food and Drug Administration clearances for a novel fingertip blood collection device and test system developed in collaboration with Babson.

The 510(k) clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit testing.

The BD MiniDraw is a capillary blood collection device that obtains blood samples from a fingerstick, making it less invasive than venous collection and potentially useful in more locations, BD said in a statement. The device is authorized for collection of blood by a trained healthcare worker without the need for a phlebotomist.

The ongoing partnership between BD and Babson Diagnostics aims to advance development of the Babson BetterWay blood testing ecosystem, which includes the BD MiniDraw and Babson's proprietary automated sample handling and analytical technologies. BD said that these have been designed to work together to enable blood testing that requires a fraction of the sample volume of traditional venipuncture methods without sacrificing quality or accuracy.

"Because the BD MiniDraw Collection System enables blood collection at nontraditional 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 Dave Hickey, executive VP and president of Life Sciences for BD.

In a separate statement, Babson noted that the new clearances will allow Babson to bring its BetterWay blood testing service to market next year. 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 payors, the Austin, Texas-based firm said.

"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.

Babson has been working with BD on the development of BD MiniDraw since 2016, the firm said, adding that BD will be a key supplier to Babson, and Babson will serve as a distributor for BD.

BD said it plans to expand blood tests enabled by the BD MiniDraw Collection System in the future.