Dr Helen V Bennett
Market Development Manager, Momentum Bioscience Ltd
Introducing a new class of product, in which all microorganisms in a whole blood sample can be captured and tested, allowing ultrasensitive detection without hours of culturing.
Detection of pathogens causing bloodstream infection (BSI) is critical to improving patient survival from sepsis and impacting antimicrobial stewardship.
Clinicians treating patients suspected of sepsis simply do not get reliable information fast enough and remain reliant on culture-based methods. The ideal is a universal, rapid, more reliable result that allows clinicians to have more confidence in their initial empirical therapy, add or adjust antimicrobials earlier and monitor the patient’s progress.
Is it sepsis or not?
Our recently automated ETGA® test, Magnitor, was piloted in studies at two different US sites during 2018. From 264 patients, 231 had negative blood cultures after 16-20 hours and gave valid Magnitor results for each of two blood bottles per patient.
When comparing Magnitor to blood culture for individual bottles, the NPV was 98.6%. The further identification aspect of the test correctly identified five of the six ETGA positives, providing no result for one patient. This was excellent performance that generated data supporting the efficacy of the Magnitor test.
Viewed as the precursor to a direct-from-blood test for positive detection, the results showed promise both in determining viability and further identification.
Saving time saves lives
Our new direct-from-blood test has been designed to capture microorganisms from 5mL of whole blood and concentrate them into a 0.1mL volume. MagRapid can universally identify the presence or absence of a viable bacterial or fungal BSI, followed by the categorisation of the causative organisms as Gram positive, Gram negative or yeast (Candida) – or combination thereof. All in less than three hours.
With further delineation being developed, this rapid molecular identification enables earlier change of therapy; a switch from IV to oral, de-escalation or a switch to antifungals. It could also enable faster focus of antibiotics in unknown BSI cases.
Revolutionising sepsis diagnostics
MagRapid is in a prototype format and will be used to test clinical samples in a multi-site study commencing in January 2020. Sites in both the US and UK will generate data to investigate performance characteristics in clinical situations, supporting further development of the MagRapid test.
The output from this test has the capability of enabling other tests to be performed sooner and can be used in downstream applications such as Antimicrobial Susceptibility Testing and Next Generation Sequencing. MagRapid could have a positive impact on antibiotic stewardship, patient management and hospital care costs.
MagRapid is designed to run on already established clinical laboratory instruments and Momentum is seeking partners for joint-commercialisation.
Read more at momentumbio.co.uk