Physicians treating children with symptoms that indicate a potential central nervous system infection—a life-threatening condition—need to know two things: whether the infection is being caused by a pathogen, and if so, its identity.
The San Diego, CA-based Rady Children’s Institute for Genomic Medicine (RCIGM), a subsidiary of Rady Children’s Hospital and Health Center, said today it has teamed up with a metagenomics startup headquartered in San Francisco, IDbyDNA, to evaluate the company’s platform as a diagnostic tool for children with such symptoms.
IDbyDNA raised $9 million in 2016 in a Series A round led by Artis Ventures, a San Francisco-based venture capital firm. ARUP Laboratories and other private investors also participated.
The startup’s founder, president, and CEO, Guochun Liao, says the technology it has developed uses next generation sequencing to detect pathogens, including bacteria, viruses, fungi, and parasites.
RCIGM and IDbyDNA together have launched a clinical trial to determine whether the platform, called Explify, can simultaneously analyze the pathogens and immune reaction in the cerebrospinal fluid of pediatric patients.
Diagnosing children who appear to have symptoms of CNS infection, such as meningitis or encephalitis, is complex. Symptoms can be general. And while it’s important for physicians to be able to identify a pathogen if it is causing an infection, doctors also need to check if symptoms are being caused by an autoimmune disease unrelated to infection, RCIGM president and CEO Stephen Kingsmore said.
Children with such symptoms can be easily misdiagnosed, and treatment for an infection versus treatment for an immune response is entirely different, said Lauge Farnaes, the study’s principal investigator and assistant medical director at RCIGM.
Samples taken for the study will be compared to more than 50,000 microorganisms and more than 3,000 pathogens in Explify’s database, according to IDbyDNA. The microbial content in the sample and the patient’s immune response will also be analyzed. The diagnostic rate and clinical utility of the sequencing will then be compared to standard testing results to determine whether the platform improves diagnostics.
In addition to Rady Children’s Hospital in San Diego—a 524-bed facility that provides medical services to San Diego, southern Riverside, and Imperial counties—tests will also take place at Children’s Hospital of Orange County in Orange, CA, and at Nicklaus Children’s Hospital in Miami, FL.