Test telling the difference between bacterial and viral infections launches – Med-Tech Innovation
DiaSorin and MeMed have launched, the novel, host-protein signature-based assay LIAISON MeMed BV in countries accepting the CE mark.
The launch follows a licensing agreement signed with MeMed that was announced in September 2020, under which DiaSorin obtained the rights to commercialise and make the MeMed BV test available on the extensive installed base of LIAISON XL and LIAISON XS platforms.
The LIAISON MeMed BV test is the first fully automated solution, which utilises host response-based data to enable physicians to differentiate accurately between bacterial and viral infections, supporting fast and better-informed treatment and patient management decisions. The test also drives laboratory operational efficiency through time-labour reduction by using a fully automated and high-throughput approach.
The availability of this test provides a valuable tool in the growing global threat posed by antimicrobial resistance (AMR). According to the World Health Organisation, AMR is in fact, one of the top 10 global public health threats for humanity and it is estimated to kill 700,000 people a year worldwide, 33,000 across the EU alone. Distinguishing between bacterial and viral etiologies in acute infections has been a universal challenge for healthcare providers. Current practices such as medical history, physical findings and other medical tests provide incomplete answers, especially when the infection site is inaccessible. By relying on the immune response, rather than direct pathogen detection, the LIAISON MeMed BV test complements conventional technologies, providing actionable information and better-informed antibiotic and antiviral treatment decisions, allowing for rapid and accurate diagnosis.
The LIAISON MeMed BV test expands DiaSorin’s range of fully automated, chemiluminescent immunoassay panels for the diagnosis of infectious diseases and highlights the Group’s efforts to develop innovative, fully automated diagnostic solutions, with the aim of optimising laboratory efficiency and clinical decision-making.
The LIAISON MeMed BV U.S. Food and Drug Administration clearance is planned for 2022.
Carlo Rosa, CEO of DiaSorin, said: “The novel test launched today with MeMed on our extensive installed base of LIAISON XL platforms is strategic for our future and provides laboratories and clinicians with an innovative diagnostic tool. The test provides significant clinical value that will support accurate and informed decisions for patients, accelerating their path to recovery. We are pleased to announce the launch of this new product during the World Antimicrobial Awareness Week. In line with the 2021 initiative motto “Spread awareness, stop resistance”, DiaSorin is now both increasing awareness of this current threat and actively contributing to efforts to stop antimicrobial resistance.”
Dr Eran Eden, CEO and co-founder of MeMed, added: “The launch of the LIAISON MeMed BV test by DiaSorin is a significant milestone in our long-term vision to drive game-changing host-response technologies that can transform patient care. The recent 510(k) clearance of MeMed BV by the US Food and Drug Administration (FDA) following a decade of research from concept to impacting patient lives represents the culmination of this journey. MeMed BV accurately distinguishes between bacterial and viral infections to improve patient management and is a critical tool in the fight against resistant bacteria. Combining the complementary strengths of our companies and providing access on the LIAISON will broaden the availability of this pioneering technology for the benefit of patients and society.”