Explify Respiratory is a validated Laboratory Developed Test (LDT) currently offered by IDbyDNA’s Salt Lake City lab for respiratory pathogens, including human coronaviruses. Since the publication of the 2019-nCoV genome, IDbyDNA’s team has analyzed in-silico generated samples and computationally validated the capability to detect 2019-nCoV and differentiate it from other human coronaviruses.
IDbyDNA has been in contact and cooperating with public health agencies to ensure a coordinated response to suspected or confirmed 2019-nCoV infections. Any such will be reported immediately to public health authorities, including the Centers for Disease Control and Prevention (CDC). The CDC has recently released interim guidance for healthcare professionals on human infections with 2019-nCoV.
The Explify platform utilizes next-generation sequencing (NGS)-based metagenomics, enabling more comprehensive pathogen detection and profiling than traditional PCR testing. Metagenomics is more resilient to quickly evolving pathogens, such as many viruses, and ensures that the test can be quickly adapted to emerging pathogens.
This is the second time in recent years that IDbyDNA was able to quickly address a critical gap in an emerging health threat via metagenomics. During the Zika virus epidemic in 2015-16, IDbyDNA’s team worked with collaborators to identify the causal Zika viral strain of the first death in the United States, as was published in the New England Journal of Medicine.
Explify Respiratory was developed, and its performance characteristics determined by, IDbyDNA Inc. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.