NEW YORK (GenomeWeb) – Metagenomics technology company IDbyDNA and The Rady Children's Institute for Genomic Medicine (RCIGM) have partnered for a clinical trial to investigate the diagnostic capabilities of sequencing technologies in pediatric central nervous system infections.
The prospective, multi-site trial — called pediatric infectious disease precision medicine using sequencing evaluation of cerebrospinal fluid (PIPSEC) — will evaluate the clinical utility of IDbyDNA's next-generation sequencing system, Explify, for identification of pathogens directly in pediatric patients with suspected CNS infections.
"The Explify platform is unique in that it can analyze many types of samples and detect all types of pathogens including bacteria, viruses, fungi, and parasites," IDbyDNA President and CEO Guochun Liao said in a statement. The platform provides unbiased pathogen detection, and is also "unbiased toward sample source," Liao added.
Explify compares NGS results to a database containing more than 50,000 microorganisms and 3,000 pathogens, analyzing both DNA and RNA in the same sample, according to the firm. Explify also provides information on both the microbes in a sample as well as a patient's immune response.
In the clinical trial, the Explify platform will be used to analyze pathogens and immune reaction in CSF of pediatric patients. The trial will be conducted at Rady Children's Hospital in San Diego, Children's Hospital of Orange County, and Nicklaus Children's Hospital in Miami, and it will compare diagnostic rate and clinical utility of standard testing to the Explify DNA and RNA sequencing results over an enrollment period of 24 months.
"Diagnosing children who present with symptoms of CNS infection is both complex and extremely time sensitive," said Stephen Kingsmore, president and CEO of RCIGM.
"It is essential for physicians to have access to solutions that will not only provide pathogen ID quickly, but will also inform them if the symptoms arise from an infection or from an autoimmune disease," Kingsmore said. "Having such a platform that can analyze all aspects simultaneously would be a game changer, which is why we are excited to work with IDbyDNA to potentially help make this test a part of the standard of care."