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Babson Diagnostics First to Conduct Full Blood Panel Testing from a Finger Sample in a Retail Setting

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A transformative medical technology company, is improving the way the public receives diagnostic blood testing.

According to the CDC, 70% of today’s medical decisions depend on laboratory test results, and over 14 billion laboratory tests are ordered annually—but primary care clinicians indicate up to 30% of prescribed diagnostic tests are not filled by patients. The conventional blood testing process was first established 70 years ago, and despite being potentially inconvenient and uncomfortable for patients, has remained because its accuracy is well-established. Babson is the first company to present a true alternative to venipuncture—using small fingertip samples less than one-tenth the volume—that does not sacrifice quality, accuracy, or menu breadth. Babson will deploy its proprietary technological ecosystem at accessible retail locations such as pharmacy counters throughout the country, giving customers the benefit of longer hours of operation, low out-of-pocket costs, and a more human experience.

Babson Diagnostics’ technological ecosystem innovates on all three steps of the diagnostic blood testing process. A next-generation capillary collection device, developed in partnership with BD (Becton, Dickinson and Company), is designed to be used by any trained healthcare worker, such as a pharmacy technician, rather than requiring a certified phlebotomist. The healthcare worker then places the collected capillary sample in Babson’s proprietary sample preparation device, which is compact and designed to fully automate all preanalytical processes, rather than requiring manual sample handling. Babson couriers will retrieve the processed samples daily and deliver them to Babson’s CLIA-certified, high-complexity microsample laboratories, where they are analyzed using Babson’s proprietary miniaturized assays. This new approach realizes both the accessibility and convenience of sample collection at retail settings and the menu breadth, quality, and efficiency of centralized analysis.

The startup recently completed a pivotal clinical study called “Dandelion Alpha,” which demonstrated the effectiveness of their proprietary sample collection, sample handling, and analysis technology. The results are momentous, because they indicate that Babson is the first company to test a full set of routine panels from a small capillary sample and produce accurate, diagnostic-quality results.

The study included 81 people enrolled during a six-week period between September and October 2020 and was conducted in a retail pharmacy, as Babson seeks to shift testing from fixed blood collection centers to customer-convenient retail settings. Each study subject received testing from both sample types: traditional venous (collected with a conventional needle and tube from the arm by a professional phlebotomist, and processed and analyzed using conventional laboratory equipment) and novel capillary (collected with BD’s fingertip collection device by a trained retail pharmacy worker, processed with Babson’s sample preparation technology, and analyzed with Babson’s miniaturized assays). Results demonstrate strong correlation between the two testing methods, providing new evidence toward establishing clinical equivalence. The results were reviewed by Babson’s Scientific Advisory Board, which is composed of renowned and award-winning diagnostic experts.

“COVID-19 has put the world’s focus on our healthcare systems, directing us to reexamine how we access care. We believe that reimagining the current clinical diagnostic testing process is an important place to start, as diagnostic blood testing is crucial for preventive care, but can be made more accessible and convenient. Babson is the first company to create a clinical and practical platform that provides accurate diagnostic blood test results for the most ordered routine testing panels from a microsample collected from a finger in an accessible retail environment,” said David Stein, Ph.D., Babson’s CEO. “Our team is gratified to see that the data from the Dandelion Alpha study supports our Science-first approach and suggests that our sample collection, sample handling, and analysis technology produces the same results as the conventional diagnostic blood testing system without sacrificing menu breadth. It’s a major step toward democratizing diagnostic testing to improve customer access to care.”

The company’s Science-first, data-driven approach is supported by its strategic partnerships with two of the world’s leading medical technology companies, Siemens Healthineers and BD.

“BD and Babson share a mutual goal of improving the customer experience of diagnostic blood testing with innovative science that focuses on accuracy and efficacy,” stated Dave Hickey, President of Life Sciences for BD. “The combination of BD’s capillary collection device and Babson’s sample handling and analysis technology has incredible potential to improve the retail diagnostic blood testing process, with the ultimate goal of enabling simple, convenient, and accessible blood testing for all.”

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