Following the successful development of their novel assay, partners in AutoPilot-Dx (Fast tracking market adoption of a novel immune-based diagnostic for improving antibiotic stewardship: automation, piloting and health economics) had been in the process of developing a point-of-care platform called Key that would allow the test, according to the BV signature based on three host protein biomarkers called BV that react differently to bacterial and viral infection, to be performed when and where needed and provide a result within 15 minutes. “This has now been completed, a CE mark has been obtained and we expect to have an FDA approval sometime in 2021,” Gottlieb says. “Today, the Key platform administering the BV test is in routine use at early access medical centres in Germany and Israel.”
Joining the battle against COVID-19
Moving on to develop BV and Key further, MeMed Diagnostics won a second EU-funded grant and began the DECODE project. “This project was originally focused on advancing our previous work under AutoPilot-Dx but as the pandemic progressed, we turned our focus to investigating potential applications of the BV biomarkers in COVID-19 patient management,” explains Gottlieb. “To support these efforts, the Commission was happy to permit the rescoping of DECODE.” In 2020, the MeMed team under DECODE has supported the development of a new product for early detection of severity in COVID-19, based on data collected from medical centres in Germany, Israel and the United States. “We have applied machine learning to derive a new signature comprising the three original BV biomarkers that indicates the likelihood of a patient infected with SARS-CoV-2 progressing to severe disease outcomes, including sepsis, respiratory failure and mortality,” adds Gottlieb. “This novel signature is the basis for a product called ‘MeMed COVID-19 Severity’ and we’re now collecting SARS-CoV-2 patient samples for the purpose of its clinical validation.” MeMed anticipates being ready to apply for regulatory approval in Europe and the United States in Q2 2021. Finally, the company is also working towards compatibility of its tests with whole blood as currently serum is required, which will expand the utility of MeMed BV and MeMed COVID-19 Severity to additional clinical settings. “EU funding has been instrumental in supporting the maturation of our products and all of this is ultimately to ensure that we can have a positive impact on patients and improve EU healthcare overall,” Gottlieb concludes.
AutoPilot-Dx, MeMed, DECODE, COVID-19, coronavirus, biomarkers, machine learning