Biomeme Clinical Study Looks To Improve Diagnostics

Written By: Biomeme Staff

Biomeme has announced its participation in a collaborative fight against antimicrobial resistance and antibiotic misuse, focusing on better diagnostic testing. With the Antibacterial Resistance Leadership Group (ARLG), a clinical research network supported by the National Institute of Allergy and Infectious Disease, and the Duke Clinical Research Institute (DCRI), a leading academic medical center, Biomeme will start the RADICAL 510k clinical study in the fall of 2023 to assess its new Host Response test. This study aims to differentiate between bacterial infections, viral infections, and noninfectious syndromes when diagnosing patients. 

The desired outcome is to help practitioners more accurately prescribe appropriate treatments, whether antibiotics or antiviral, in the fight against antimicrobial resistance by using appropriate therapeutics for each infection.

To better understand the impact this test and collaboration can have on the world, let’s first discuss the AMR crisis and its impact on overall global health.

The AMR Crisis and Global Health

Antimicrobial resistance (AMR) occurs when microorganisms, such as bacteria, viruses, fungi, and parasites, develop the ability to resist the effects of medications that were once effective in treating them. The main types of antimicrobial agents affected by resistance include antibiotics, antivirals, antifungals, and antiparasitic drugs.

The AMR crisis has emerged due to various factors, including the misuse and overuse of antimicrobial drugs in human medicine, animal agriculture, and agriculture in general. Its impact on global health is significant and far-reaching and will result in more infections, longer hospital stays, limited treatment options, overall poorer economies, and more.

What Is the RADICAL 510k Clinical Study?

The collaboration among Biomeme, ARLG, and DCRI is designed for the RADICAL 510k study to benefit from the expertise and oversight of leading global health and clinical experts specializing in antibiotic-resistant infections. Christopher Woods, MD, MPH, the Chief Medical Officer at Biomeme, emphasized the significance of this study:

“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.”

Why the RADICAL 510K Clinical Study Is Necessary

When faced with an infection, healthcare providers face challenges in accurately identifying whether to treat bacterial or viral disease. As a result, 20-40% of antibiotic prescriptions prove unnecessary. Using inappropriate treatment not only jeopardizes the well-being of individual patients but also escalates the expenses linked with their treatment and exposes others to the risk of contracting drug-resistant infections.

Unfortunately, conventional tests to distinguish between bacterial and viral infections can be unreliable. However, Biomeme's groundbreaking HR-B/V test has the potential to emerge as a promising solution to address this issue. 

As Biomeme’s HR-B/V test aims to help practitioners decipher the difference between bacterial and viral, patients can be properly diagnosed and only prescribed antibiotics when absolutely necessary. This leads to improved stewardship and appropriate use of antibiotics, and will make them more effective when properly prescribed. 

What’s Next for AMR and Biomeme

We look forward to using the clinical study to help improve diagnoses and treatments globally, better informing those studying antimicrobial resistance issues. By combatting the wicked problems that revolve around antimicrobial resistance, with collaborations like these, we are better able to work together toward One Health and create a world where people, animals, and plants can live harmoniously and support one another for a healthier future.

Regulatory Disclaimer: Biomeme's HR-B/V Test is currently under development and is not approved/cleared by the FDA.

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