BD, Magnolia Medical Technologies Announce Commercial Collaboration to Help Reduce Blood Culture Contamination and Improve Testing Accuracy

FRANKLIN LAKES, N.J., Oct. 18, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Magnolia Medical Technologies, Inc., today announced a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination to help improve testing accuracy and ultimately improve clinical outcomes.

Under the agreement, BD and Magnolia Medical will both co-sell and co-market Magnolia Medical's Steripath® and Steripath® Micro Initial Specimen Diversion Device® platforms, complementing the BD specimen collection portfolio, including BD Vacutainer® push button and BD Vacutainer® UltraTouch™ blood collection sets.

Steripath® is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination for sepsis testing accuracy.ⁱ The Steripath® Initial Specimen Diversion Devices divert and sequester the initial 1.5 to 2 mL of potentially contaminated blood from the sample and then collect blood for blood cultures.

The Steripath platform offers the only all-in-one devices clinically proven to meet the Clinical and Laboratory Standards Institute's (CLSI) new 1% blood culture contamination goal and new U.S. Centers for Disease Control and Prevention (CDC) guidelines to reduce blood culture contamination. The CDC guidelines specifically recommend use of Initial Specimen Diversion Devices [which] divert the initial 1 to 2 mL of potentially contaminated blood and then collect blood for blood culture.^{ii ,iii, iv}

"Sepsis is the number one cause of death, readmissions and costs in hospitals today," said Brooke Story, BD Integrated Diagnostic Solutions president. "It's estimated that up to 56% of positive blood cultures can be contaminated during collection. Reducing blood culture contamination can help improve testing accuracy and ultimately improve clinical outcomes and may lessen the threat of antibiotic resistance by giving health care practitioners more specific, reliable results." 

Greg Bullington, CEO of Magnolia Medical, added, "This collaboration represents a strong step forward in advancing our Mission to ZERO® initiative to increase awareness within the health care community of the role that accurate testing plays in enabling antimicrobial stewardship and quality outcomes. By offering a combined innovative technology solution with the Steripath® Initial Specimen Diversion Device® platform and BD Vacutainer® push-button and BD Vacutainer® UltraTouch™ blood collection sets, we are aligning our shared commitment to improve patient outcomes, help hospitals achieve their quality goals, and reduce unnecessary hospital costs."

To date, 20 studies have been completed supporting the clinical and cost effectiveness of Steripath. All clinical studies reported sustained contamination rates of 1% or less using Steripath and a study achieved a 31% reduction in vancomycin days of therapy. ^{v, vi}

Steripath has been adopted by hundreds of U.S. hospitals and health care systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted health care resources.

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique® (ISDT®) and Initial Specimen Diversion Device® (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio, including more than 100 issued method, apparatus, and design patents with more than 70 additional patent applications pending. For more information, visit magnolia-medical.com or connect with us on LinkedIn at http://www.linkedin.com/company/magnolia-medical-technologies/

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

ⁱ Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion. K192247 (Steripath Gen2 Blood Collection System FDA clearance letter).
ⁱⁱ CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
ⁱⁱⁱ CDC Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022
^iv CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022
^v Data on file.
^vi Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device® reduces blood culture contamination and vancomycin use in academic medical center. J Hosp Infect. 2021;117. doi:https://doi.org/10.1016/j.jhin.2021.10.017.

SOURCE BD (Becton, Dickinson and Company)