BD (Becton, Dickinson and Company) has announced it has received 510(k) clearances from the U.S. Federal Drug Administration (FDA) for a novel blood collection device that obtains blood samples from a fingerstick that produce laboratory-quality results for some of the most commonly ordered blood tests.
The BD MiniDraw Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient's finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein. The innovative design provides a sample that produces laboratory-quality blood test results from a fraction of the volume of traditional venous collections. It is less invasive than traditional venous blood collection methods and more convenient for the patient by expanding access to blood collection to new locations, including retail pharmacies. The device may provide a better patient experience and has the potential to transform diagnostic testing.
The 510(k) clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and haemoglobin and haematocrit (H&H) testing. These tests are among the most commonly ordered laboratory tests and can be used to diagnose and monitor a variety of chronic conditions from hypertension to high cholesterol. BD plans to expand blood tests enabled by BD MiniDraw Collection System in the future.
"Because the BD MiniDraw Collection System enables blood collection at non-traditional sites that may be more convenient - like a local pharmacy rather than a standalone laboatory - 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 Vice President and President of Life Sciences for BD. "This innovation is our strategy and pipeline coming to life, and proof of our commitment to enabling diagnostics and care in alternate settings."
In May 2022, BD and Babson Diagnostics announced an expansion of their original strategic partnership agreement, announced in 2020, to advance development of the Babson BetterWay blood testing ecosystem, which includes the BD MiniDraw Collection System and Babson's proprietary automated sample-handling and analytical technologies. These were designed to work together to enable blood testing that requires only a fraction of the sample volume of traditional venipuncture methods without sacrificing quality or accuracy.