Regulatory Approval For Novel Device Achieved With Comprehensive Clinical Data Management

When a patient presents with a fever or what appears to be an acute infection, clinicians face a seemingly simple question: should antibiotics be prescribed or not? Distinguishing between bacterial and viral infections is a major diagnostic challenge because the symptoms are often very similar. Beyond an ineffective treatment for viral infections, prescription of antibiotics, particularly their overuse and misuse, contributes to antimicrobial resistance (AMR).

A leader in the emerging field of advanced host-response technologies, MeMed set out to address this diagnostic challenge. Over the course of a decade, the company developed novel technology that accurately and rapidly decodes the body’s immune response to infection, the ‘host response’, rather than focusing on detecting the presence of a microbe. This allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection are emerging new pathogens.

MeMed’s “APOLLO” study assessed the diagnostic performance of the MeMed BV® test on the point-of-need platform MeMed Key®, evaluating the technology’s ability to help healthcare providers accurately and rapidly distinguish between bacterial and viral infections. To ensure successful submission and regulatory approval of its study, reduce overall trial costs and add an extra layer of objective quality control, MeMed engaged Bioforum. A data focused CRO with extensive experience in medical device, diagnostic and infectious disease clinical trials, Bioforum was selected to support all data capture and management activities, as well as to provide programming and medical writing support for the clinical study report (CSR).