Karius, a life sciences company transforming infectious disease diagnostics with genomics, along with St. Jude Children’s Research Hospital, the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children, announced today at IDWeek™ 2018 the positive results of the pilot phase study of high-risk pediatric leukemia patients vulnerable to serious, life-threatening infections
REDWOOD CITY, California — Karius, a life sciences company transforming infectious disease diagnostics with genomics, along with St. Jude Children’s Research Hospital, the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children, announced today at IDWeek™ 2018 the positive results of the pilot phase study of high-risk pediatric leukemia patients vulnerable to serious, life-threatening infections. The PREDSEQ study shows that the Karius® Test, a non-invasive blood test that detects pathogen DNA in plasma, is able to identify patients with bloodstream infections (BSI) before they have symptoms or a positive blood culture. These results are the first step to determining whether detection of pathogen DNA in blood could be used as a monitoring tool to enable pre-emptive antimicrobial treatment of bloodstream infections in high-risk pediatric cancer patients. This could reduce the serious consequences of bloodstream infections in these patients while also limiting their use of prophylactic antibiotics.
“The results of our study with St. Jude Children’s Research Hospital demonstrate the ability of the Karius Test to identify bloodstream infections prior to clinical symptoms,” said Dr. David Hong, a pediatric infectious diseases doctor and VP of Medical Affairs and Clinical Development at Karius. “The PREDSEQ study to be presented at IDWeek shows the promise that the Karius Test could potentially be used as a monitoring tool in severely immunocompromised children to enable earlier detection of bloodstream infections.”
“We are excited to share the results of our research at IDWeek showing that plasma metagenomic sequencing appears to be sensitive for prediction of bloodstream infections from a broad range of pathogens, including bacteria that cause high mortality and morbidity among pediatric cancer patients,” said Dr. Joshua Wolf, a pediatric infectious diseases doctor and associate faculty member at St. Jude. “We have been looking for a ‘crystal ball’ to help identify patients who are about to get sick, and this is a step in the right direction.”
“Our leukemia treatment protocols are now curing a high percentage of children, making addressing the infectious complications of their treatment even more important as we aim to further increase survival rates,” said Dr. Charles Gawad, a leukemia specialist and assistant faculty member at St. Jude. “This study shows that it may be possible to reduce these complications with the purposeful application of this exciting new technology.”
Findings
Researchers at St. Jude enrolled 31 pediatric patients receiving treatment for relapsed or refractory malignancy at high risk of serious infection in an IRB-approved prospective cohort study and sent blood samples to the Karius laboratory. Karius uses next-generation sequencing (NGS) to detect microbial cell-free DNA in patient plasma from over 1,000 pathogens known to cause disease, including bacteria, DNA viruses, fungi, molds and eukaryotes.
Episodes of febrile neutropenia or documented infection were collected prospectively from medical records and BSI was defined according to National Healthcare Safety Network (NHSN) criteria. Control samples were defined as samples collected ≥7 days before or after any fever or documented infection. After filtering human sequences, reads were aligned to a curated pathogen database, and organisms above a statistically significant threshold were reported by Karius.
A total of 11 BSI episodes occurred in 9 participants during the study period. Predictive sensitivity of NGS in the 2 days before onset of infection (n = 9) was 78% (95% CI 40 – 99.7%), and diagnostic sensitivity on the day of infection (n = 11) was 82% (48 – 98%). Specificity of NGS for development of fever or infection within 7 days (n = 10) was 80% (95% CI 44 – 98%). NGS was positive up to 6 days prior to onset of BSI. In samples collected before or during documented infections, NGS also identified multiple additional uncultured bacteria and fungi.
The complete study results will be presented as an oral abstract this Saturday, October 6 by St. Jude investigators Dr. Kathryn Goggin, Dr. Josh Wolf and Dr. Charles Gawad:
Additional St. Jude authors include Yuki Inaba BS, Veronica Gonzales-Pena PhD, Kim Allison BSN, Gabriela Maron MD, Randall Hayden MD, PhD, John Choi MD, PhD, and Jeff Rubnitz MD, PhD. Karius authors are Ka Lok Chan MS, Desiree Hollemon MSN, MPH, Asim Ahmed MD, and David Hong MD.
About Karius, Inc.
Karius is a life sciences company focused on transforming infectious disease diagnosis with genomics through the innovative use of next-generation sequencing to analyze microbial cell-free DNA. The Karius laboratory is CLIA-certified and CAP-accredited to perform high-complexity clinical laboratory testing. The company’s genomics platform and clinically-curated pathogen database deliver deep insight into the microbial landscape, providing clinicians with a comprehensive, quantitative test capable of identifying more than a thousand pathogens directly from blood. For more information, visit kariusdx.com and follow us on Twitter at @kariusdx.
About St. Jude Children’s Research Hospital
St. Jude Children’s Research Hospital is leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20 percent to 80 percent since the hospital opened more than 50 years ago. St. Jude freely shares the breakthroughs it makes, and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing and food — because all a family should worry about is helping their child live. To learn more, visit stjude.org or follow St. Jude on social media at @stjuderesearch.
