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Biocartis and Microbiome to Develop Rapid and Sensitive Sepsis Test

Biocartis, an innovative molecular diagnostics company, and Microbiome, a spin-off of the VU University Medical Center Amsterdam, today announced to have entered into a worldwide license and collaboration agreement for the development of an integrated multiplex real-time PCR assay for rapid detection of bloodstream infections.

Under the terms of the collaboration and license agreement, Microbiome’s multiplex PCR assay for identification of sepsis-causing microorganisms will be further developed as an integrated multiplex real-time PCR assay on Biocartis’ Idylla™ platform for use in conjunction with a new platform under development by Biocartis, called Idylla™-Enrich. Financial details of the agreement are not disclosed.

Idylla™-Enrich is a dedicated pre-enrichment platform for bloodstream infections. Rudi Pauwels, Chief Executive Officer of Biocartis, commented: “Molecular diagnostics for bloodstream infections pose a classical needle-in-a-haystack problem; the vast excess of human DNA limits the amount of blood sample that can be used in a pathogen specific molecular analysis. The ability of our Idylla™-Enrich platform to selectively enrich pathogen DNA from 10 ml of whole blood represents an enormous breakthrough in sensitivity as low pathogen concentrations down to 1 colony-forming unit (CFU)/ml can now be detected.”

The Idylla™-Enrich method has extensively been tested as part of the largest sepsis study in Europe to date comprising almost 7,500 clinical samples.[1] Biocartis will further develop the platform and plans to launch it for use in conjunction with the pathogen identification test licensed from Microbiome as a streamlined solution for the diagnosis of bloodstream infections.

Sepsis occurs when the body’s response to an infection spirals out of control and can progress to severe sepsis or septic shock, with a mortality rate of nearly 50% in the event of severe sepsis[2]. Almost 30 million patients per year worldwide encounter a septic episode.[3]

There is evidence that a delay in the treatment of a patient with sepsis increases mortality by 7.6% per hour in the first six hours[4]. These figures call for a faster and more accurate diagnosis. When diagnosing sepsis or bloodstream infections, typically a blood sample of the patient is analyzed for the presence of pathogens. Today’s gold standard approach to detect the pathogens is blood culture which typically takes 24-48 hours for bacteria and even 5 days for fungi, which considerably delays a targeted therapy and contributes to high sepsis mortality.

By combining the enrichment with a multiplex PCR assay on the Idylla™ platform it is possible to identify pathogens in bloodstream infections much faster, reducing current approaches of 24-48 hours to as little as 2 hours.

Paul Savelkoul, Chief Executive Officer of Microbiome, commented: “The combination of rapid and highly sensitive identification of bloodstream pathogens with a panel of key antimicrobial resistance genes will have a major impact on clinical practice. This assay will enable clinicians for the first time to initiate optimal treatment within hours instead of days after admission of a patient. As a spin-off of a medical center, Microbiome builds on extensive clinical experience. Combined with Biocartis’ technology, we feel we are creating the optimal clinical sepsis test.”

Prof. Jean-Louis Vincent, Professor of Intensive Care Medicine (University of Brussels) and a key opinion leader in the field of sepsis management commented, “Early and adequate antimicrobial therapy is of paramount importance in the management of severe infections. There is a real unmet clinical need for tests providing rapid identification of microorganisms so that appropriate antibiotics can be started as soon as possible.”

[1] The Molecular Diagnosis and Risk Stratification of Sepsis (MARS) study was conducted and funded under the framework of the CTMM (Center for Translational Molecular Medicine, The Netherlands) from 2010-2015.
[2] Jawad et al., J Glob Health (2012); 2: 010404
[3] 2015 World Sepsis Day Factsheet by Global Sepsis Alliance
[4] Kumar et al., Crit Care Med. (2006);34:1589-96

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