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Introducing the first NGS-based respiratory infectious disease test

Explify Respiratory provides physicians with a more accurate, more comprehensive, and hypothesis-free approach to diagnosing pneumonia. One test identifies >200 common and rare bacterial, viral, and fungal respiratory pathogens.

 

Explify Respiratory is useful for:

 

  • Identifying organisms that may not grow well in culture
  • Detecting co-infections by multiple pathogens
  • Detecting rare or uncommon pathogens, especially in immunocompromised patients
  • Patients who previously tested negative with conventional tests

 

Explify Respiratory provides physicians with answers even if they don’t know what pathogens to look for.

Today’s diagnostic dilemma

Over 1 Million hospitalized pneumonia patients per year

Each year, more than one million patients in the United States alone are admitted to the hospital and treated for pneumonia and related symptoms.

In up to 60% of cases, a pathogen is never identified

The laboratory work-up for pneumonia involves multiple tests. Traditional testing methods are limited to specific pathogens and return negative results in up to 60% of pneumonia cases.

  • Cultures and stains lack sensitivity, many pathogens may not be detectable.
  • Many organisms do not grow well in culture or do not survive specimen transport.
  • Routine PCR tests target mostly viruses, individually or in limited panels.
  • Genetic variation can be a challenge to routine PCR testing, and variant strains can be missed.

The solution: Explify Respiratory

Accurately detects > 200 common and rare respiratory pathogens with a single test

Utilizing both DNA and RNA sequencing enables Explify Respiratory to detect and identify bacterial, viral, and fungal pathogens by their unique genetic signatures.

Utilizing next-generation sequencing (NGS) technology and IDbyDNA’s proprietary best-in-class search and data analysis software, Explify Respiratory identifies common pathogens, and rare pathogens clinicians may not have expected to find or thought to test for.

An unbiased approach to diagnosis

Unlike conventional pneumonia tests which rely on clinicians forming a hypothesis to direct their test ordering, Explify Respiratory provides clinicians with a hypothesis-free approach to respiratory infectious disease diagnosis. It detects bacteria, viruses, and fungi in one assay, and provides interpretive comments by experts to aid clinicians in the management of their patient.

Published data demonstrates Explify Respiratory identifies critical pathogens missed by conventional testing

41 specimens from immunocompromised children with respiratory disease resulted negative using a battery of routine laboratory tests (e.g. negative for cultures, stains, EIA, and PCR)

Explify Respiratory:

  • Identified putative pathogens in 18 (44%) of specimens
  • Of the 18 specimens detected positive
    • Detected a single pathogen in 12 (67%)
    • Detected 2 pathogens in 5 (28%)
    • Detected 4 pathogens in 1 (5%)
  • Detected pathogens including:
    • 13 bacteria
    • 7 fungi
    • 3 viruses
*The results of this clinical utility study were presented at the 2017 American Thoracic Society annual meeting in collaboration with The Children’s Hospital of Philadelphia

The Explify Respiratory assay was validated in a CLIA setting

Metagenomic test validation for clinical use that fulfills regulatory requirements poses unique challenges, because standard approaches used for conventional tests may not apply. The validation of Explify Respiratory including; laboratory protocols, data analysis algorithms, reference databases, and the establishment of rigorous quality control metrics was performed based on the framework proposed in The Archives of Pathology and Laboratory Medicine.

Ordering Explify Respiratory is simple

Explify Respiratory is currently available to order from ARUP Laboratories. Ordering Explify Respiratory requires no additional processes or steps than ordering other routine tests from ARUP.

For ARUP ordering information click here.
Please submit: bronchial alveolar lavage (BAL) samples, click here to learn more.