Guiding Therapy
Ultimately, he added, the purpose of a diagnostic test is to “generate actionable information that could potentially guide therapy.”
Researchers are now evaluating medical charts of the same subcohort of patients to determine whether the test made a clinical difference.
“We want to know if it had a positive or negative or no clinical impact on the management and treatment of patients,” said Dr. Chiu. “Producing data like this will help us define the role of this test in the future as part of the diagnostic paradigm.”
The researchers are also working on a cost/benefit analysis, and Dr. Chiu said that US Food and Drug Administration approval of the test is needed “to establish a blueprint for reimbursement.”
Commenting on the findings, Jessica Robinson-Papp, MD, professor and vice chair of clinical research, Department of Neurology, Icahn School of Medicine, New York, said that the technology could be useful, especially in developing countries with higher rates of CNS infections.
“What’s really exciting about it is you can take a very small CSF sample, like 1 mL, and in an unbiased way just screen for all different kinds of pathogens including both DNA and RNA viruses, parasites, bacteria, and fungi, and sort of come up with whether there’s a pathogen there or whether there is no pathogen there,” she said.
However, there’s a chance that this sensitive technique will pick up contaminants, she added. “For example, if there’s a little environmental bacterium either on the skin or in the water used for processing, it can get reads on that.”
The study received support from Delve Bio and the Chan-Zuckerberg Biohub.
Dr. Chiu has received personal compensation for serving on a Scientific Advisory or Data Safety Monitoring Board for Biomeme and has stock in Delve Bio, Poppy Health, Mammoth Biosciences, and BiomeSense and has received intellectual property interests from a discovery or technology relating to healthcare. Dr. Robinson-Papp has no relevant conflicts of interest.
A version of this article appeared on Medscape.com.