Today’s diagnostic dilemma

Over 13 Million pneumonia patients require hospitalization per year

Each year, more than 13 million patients globally require hospitalization and treatment 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

Unlike conventional tests which only can detect a limited number of pathogens, Explify Respiratory applies an unbiased approach to finding any microorganism in a sample.

 

Applying metagenomic DNA and RNA sequencing enables Explify Respiratory to detect and identify bacterial, viral, and fungal pathogens by their unique genome sequences. The shift from conventional testing for preselected pathogens to an unbiased metagenomic-based approach can help identify microorganisms that have previously been missed.

Explify Respiratory is useful for identifying:

 

  • Common and rare pathogens
  • Pathogens that are difficult to culture
  • New strains
  • Complex co-infections

 

Explify Respiratory provides physicians with answers even if they aren’t sure of what pathogens to test for. The test is also useful for immunocompromised patients and patients who previously tested negative with conventional tests.

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.

Explify Research Specimen (EXPRESS) Collection and Analysis Protocol

IDbyDNA created The EXPRESS Protocol, an IRB approved study designed to create a broad repository of multiple specimen types from patients with any infectious syndromes with matched analyzed metagenomic results. Specimens may include blood, plasma, serum, sputum, nasal swab, bronchoalveolar lavage (BAL), tracheal aspirate/secretion, pleural fluid, cerebrospinal fluid (CSF), synovial fluid, intraocular fluid, urine, fecal, or other bodily fluids/tissues such as those obtained during clinically indicated procedures (e.g., bronchoscopy, thoracentesis, or biopsy of an infection site). If you are a researcher and interested in enrolling patients in EXPRESS contact us at EXPRESS@idbydna.com.