Noscendo Background

First you have to recognize and diagnose most reliably the infecting agent in order to successfully treat the infected patient.

Medical Need

Sepsis is a disease with high case numbers, high mortality and extremely high healthcare cost. Blood culture as the current gold standard for sepsis diagnosis has severe disadvantages. New molecular diagnostic tests offer shorter time to diagnosis, yet require precognition of causative microbes and high bacterial burden. An ideal solution to overcome current shortcomings requires quantitative analysis of a biomarker class which is much more frequently present.

I. What we offer:

Noscendo Technology

Noscendo identifies pathogens via Next-Generation-Sequencing of cell free nucleic acids in patient’s plasma samples.

The process in its current set-up already offers competitive time to diagnosis (~24 h) and further reduction in time is linked to advances in sequencing technology.

The Bioinformatic Workflow provides an open detection of bacteria, fungi, viruses and parasites without prior knowledge.

The proprietary relevance assessment assigns statistical significance to each detected microbe and therefore enables discrimination between colonizing and infecting species.

 

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1. Blood Sample

Cell free nucleic acids are prepared for Next Generation Sequencing Analysis in patient’s blood plasma samples.
 

2. Sequencing

The patient‘s sample is processed by high throughput (next generation) sequencing.
 

3. Bioinformatic Analysis

Reads are categorized into non-human and human reads. Reads classified as of non-human origin are compared to  a large database of more than 5000 genomes.
 

4. Diagnostic Report

The relevance assessment enables statistical evaluation by including reference control cohorts and makes discrimination of commensalism vs. Pathogenicty possible.

 

 

For further information please see: Grumaz S, Stevens P, et al. Genome Med. 2016 Jul 1;8(1):73.

Details: Differentiate commensals from infecting agents

The distinction between infectious agents and contamination/ colonization is calculated based on the fraction of non-human reads found in the patient‘s sample.
Discrimination between colonizing species (non-pathogenic but possibly found in each patient in high abundances) and infecting species (pathogenic but in some cases possibly only low abundance) needs to be done in an automated way. Helping clinicians treating their patients in a fast and effective manner.

  • One example for low significance is a frequent commensal/ contaminant which is highly abundant in all patients and controls
  • An example for high significance is a pathogenic microorganism which is detected only in individual patient samples but not in non-infected controls or the remainder of patient samples

Changes in the displayed and reported releveance assigned to a specific microbe detected in a patient's plasma over time can hint to progression/ relief of infection.

II. How it works:

For Clinicans

Two finished joint clinical trials of Fraunhofer IGB together with sepsis experts at University Hospital Heidelberg validated the initial concept with more than 370 patient samples.

New Clinical Studies are currently prepared.

Please contact us if you need further intormation on Noscendo services, are interested to test or implement Noscendo diagnostics in your hospital or interested to participate in clinical studies.

Finished Clinical Trials (Carried out by University Hospital Heidelberg and Fraunhofer IGB)

Clinical Study RAMMSES MIRSI
Study Scope
  • Primary analysis (PA): Methylglyoxal as a new biomarker in patients with septic shock
  • Secondary analysis (SA): NGS diagn-ostics of bacteremia in septic patients
  • Primary analysis: Mycotic infections in immunosuppressed septic patients
  • Amendment: NGS diagnostics in septic patients
# patient samples PA: 114, SA: 32 PA: 257, Amendment: 257
# control samples PA: 120, SA: 30 PA: 0, Amendment: 71
Duration 28 days 28 days
Clinical Results
  • PA: Methylglyoxal as more useful marker than routine diagnostic markers
  • SA: Proof of concept of NGS diagnosis of sepsis based on circulating nucleic acids
  • PA: unpublished
  • Amendment: Comparison of next-generation sequencing diagnostics with conventional clinical microbiology in a retrospective study
Publication PA: Brenner et al. Critical Care (2014) 18:683; SA: Grumaz et al. Genome Medicine (2016) 8:73 PA: in preparation Amendment: in preparation

New Clinical Studies

New Clinical Studies are currently prepared.

Please contact us if you need further intormation on Noscendo services, are interested to test or implement Noscendo diagnostics in your hospital or interested to participate in clinical studies.

III. How it is done:

For Lab Managers

You are providing diagnostics in the field of sepsis? And are eager to help clinicians treat their patients the best way?

Supported by strategic partners in the area of diagnostic development, logistics and next generation sequencing services, we can offer to you:

  • The send-in model: We arrange the pick-up of the samples you want us to analyse and report back to you. This model will be available with the start of 2018.
  • The enabling model: If you already have necessary equipment and want to use the technology but not send out samples. We will train your staff to generate the data and use the Noscendo technology to help diagnosing critically ill patients. This model will be set up during 2018.

Please contact us if you need further intormation on Noscendo services, or if you are interested to test or implement Noscendo diagnostics in your hospital, so we can set up a service tailored to your needs.

1

noscendo offers to you:

Logistics - sample pick up;
Sample Preparation;
Sequencing;
Data Analysis;
Report.

2

noscendo offers to you:

Logistics (at defined affiliated lab);
Sample Preparation;
Sequencing;
Data Analysis;
Report (via Hospital central lab).

3

noscendo offers to you:

We enable your staff to use your own infrastructure for sample preparation and sequencing from there we will provide data Analysis;
and the final Report.

Testing and implementing next generation Sepsis Diagnostics

Please contact us if you need further intormation on Noscendo services or if you are interested to test or implement Noscendo diagnostics in your hospital or your diagnostic laboratory.

Technical Specifications – send-in / clinicians

We will provide every necessary information tailored to your needs. These information will include, for example, how the pick up of a sample is arranged and what needs to be taken care of when taking a sample. If you have any question - contact us

Technical Specifications – send-in / lab

We will provide every necessary information tailored to your needs. These information will include, for example, how the pick up of a sample is arranged at your lab or how the results of the technology come back to you. If you have any question please contact us