Clinical evidence

High-risk patients frequently harbor atypical pathogens leading to inaccurate SOC testing and ineffective therapeutics. Genomic-based diagnostics may improve accuracy of urogenital pathogen detection and offer physicians precision therapeutics with better health outcomes while enhancing antimicrobial stewardship.

Chronic villitis (CV) is characterized by the presence of lymphocytes, histiocytes or rarely plasmacells within villous stroma. Infectious causes of CV account for approximately 5% of cases; for theremainder (approximately 95%), pathogenesis is unclear. Chronic villitis of unknown etiology(VUE) is associated with adverse fetal outcomes, including intrauterine growth restriction and fetaldemise. Aberrant maternal immune responses have been implicated as a cause of VUE, butundetected causative or precipitating infections have been difficult to exclude. Herein, we performedpan-viral sequencing of placentas with infectious villitis and VUE to potentially detect the presenceof undetected viruses in cases of VUE.

We have built and validated a clinical-grade sequencing-based pipeline that accurately identifies key pathogens in clinical urine samples using a machine learning classification approach.

Urine has historically presented a challenge for diagnostics via culturing, with a high rate of culture-negative results (~30% on average). We improved the clinical utility of an NGS urine assay by leveraging an IPC and ML software. This decreased the rate of false positive species called in a sample relative to other NGS techniques and allows for greater sensitivity and axonomic specificity. This assay may be especially useful for low colony-count or negative-culture samples to diagnose and guide patient treatment.

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In this prospective observational study performed at a musculoskeletal specialty hospital in the U.S., we enrolled 53 adults with validated hip or knee periprosthetic joint infections. Microbial cfDNA from pathogens causing local periprosthetic joint infections can be detected in peripheral blood. These circulating biomarkers can be sequenced from noninvasive venipuncture, providing a novel source for joint pathogen identification.