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Biomeme is launching a clinical study aimed at spearheading the attack against antibiotic misuse and antimicrobial resistance (AMR). Biomeme, in collaboration with the Antibacterial Resistance Leadership Group (ARLG) and the Duke Clinical Research Institute (DCRI), plans to begin their “RADICAL 510k” clinical study evaluating their new host response test in the fall of 2023.
PHILADELPHIA , July 20th, 2023 /PRNewswire-PRWeb/ — In a June 2023 policy brief, the World Health Organization (WHO) included the need for diagnostic tests to discriminate between bacterial infections, viral infections, and noninfectious syndromes on their list of 40 research priorities to combat AMR[1]. Globally, 4.95 million deaths were linked with AMR in 2019.[2] In the United States, statistics show that antibacterial-resistant infections affected more than 2.8 million individuals, resulting in over 35,000 fatalities.[3] The inappropriate prescription of antibiotics for viral illnesses compounds this issue, leading to increased healthcare costs,[4-6] prolonged hospital stays, and the need for more intensive and expensive care.[7]
Recognizing the gravity of the AMR crisis, Biomeme, ARLG, and DCRI are committed to researching practical solutions that empower physicians by providing them with timely and accurate diagnostic information, thus facilitating informed decisions regarding antibiotic treatment. One possible solution is the new Biomeme host response test that differentiates bacterial and viral infections, which is the subject of the RADICAL 510k study.
Christopher Woods, MD, MPH, Chief Medical Officer at Biomeme, said “This study will explore whether Biomeme’s solution addresses a critical gap in our diagnostic armamentarium– a tool that accurately informs physicians if their patients have a bacterial or viral infection in a timely manner.”
“AMR is a systemic and global problem of huge proportions against which progress has been stalled during COVID-19. Creating preventative approaches to promote prudent antimicrobial use through a One Health approach is imperative to addressing this global health issue,” said Vance Fowler, MD, MHS, Duke University and ARLG Co-Principal Investigator.
The collaboration between Biomeme, ARLG, and DCRI ensures that the RADICAL 510k study will benefit from the oversight of leading global health and clinical experts specializing in antibiotic-resistant infections.
“This is a great opportunity for some of the world’s leading researchers in this space to work together to evaluate new products with the potential to improve antibiotic stewardship,” said Thomas Holland, MD, Duke University and Principal Investigator for the RADICAL 510k study at DCRI. “We are working with the FDA on the study design and are very appreciative of their input thus far.”
By incorporating bacterial and viral host response differentiation testing into its product portfolio, Biomeme takes a significant stride towards achieving its mission of empowering individuals to embrace One Health. Through this collaboration, the organizations involved aim to change the field of diagnostics, providing physicians with a reliable and accessible tool that will greatly contribute to the global fight against antibiotic misuse and AMR.
About Biomeme:
Biomeme revolutionized molecular detection in 2012 when it created the first smartphone-based real-time PCR thermocycler. Since its inception, Biomeme has used advanced biology and chemistry, along with world-class hardware and software engineering, to create elegant solutions to complex problems.
Headquartered in Philadelphia, USA, Biomeme offers a full suite of end-to-end mobile molecular detection solutions that perform to the gold standard used by the world’s most advanced central labs yet require no lab equipment or prior experience to use.
To find out more about Biomeme, visit biomeme.com.
Disclosures:
Duke as an institution holds equity in Biomeme. In accordance with Duke University IP policies and procedures, Duke University might benefit financially if the test proves effective and is successful commercially.
Research discussed in this publication is supported in part by the ARLG Grant, the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Dr. Woods represents Biomeme during the RADICAL 510k study as Chief Medical Officer. He also holds the following roles: Executive Director at the Hubert-Yeargan Center for Global Health, Wolfgang Joklik Distinguished Professor of Global Health, Professor of Medicine (all at Duke University), and Chief of Infectious Diseases at the Durham VA Medical Center.
References:
[1] World Health Organization: WHO. (2023). Global Research Agenda for Antimicrobial Resistance in Human Health [Policy Brief]. https://www.who.int/publications/m/item/global-research-agenda-for-antimicrobial-resistance-in-human-health
[2] Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19. Erratum in: Lancet. 2022 Oct 1;400(10358):1102. PMID: 35065702; PMCID: PMC8841637.
[3] Centers for Disease Control and Prevention (U.S.) (2019). Antibiotic resistance threats in the United States, 2019. http://dx.doi.org/10.15620/cdc:82532.
[4] Gould IM. Antibiotic resistance: the perfect storm. Int J Antimicrob Agents. 2009 Aug;34 Suppl 3:S2-5. doi: 10.1016/S0924-8579(09)70549-7. PMID: 19596110.
[5] Lee GC, Reveles KR, Attridge RT, et al. Outpatient antibiotic prescribing in the United States: 2000 to 2010. BMC medicine 2014; 12: 96.
[6] Obama B. Executive Order – Combating Antibiotic-Resistant Bacteria. In: House TW, editor.: Office of the Press Secretary; 2014.
[7] World Health Organization: WHO. (2021). Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
Pull Quote
AMR is a systemic and global problem of huge proportions against which progress has been stalled during COVID-19. Creating preventative approaches to promote prudent antimicrobial use through a One Health approach is imperative to addressing this global health issue.
Media Contact
Tom Cook, Biomeme, 1 (267) 930-7707, [email protected], biomeme.com
SOURCE Biomeme
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