Karius to Present Data on The Karius Test at ASM Microbe 2018

Announces Newly Expanded, Comprehensive Genomic Diagnostic for Infectious Diseases Covering 1,320 Pathogens with a Single Blood Test

REDWOOD CITY, Calif. — June 5, 2018 — Karius, a life sciences company focused on transforming infectious disease diagnostics with genomics, announced expanded bacterial and fungal coverage for its quantitative next-generation sequencing (NGS) plasma test for pathogen detection today. The Karius Test™ has been expanded by 70 microorganisms, now detecting 1,320 pathogens from one blood draw with next day results*. The test provides broad-based detection of clinically relevant pathogens, including more than 750 species of bacteria, over 100 DNA viruses and more than 300 fungi and molds. Scientists and clinicians will present data on the Karius Test performance and clinical applications in several sessions at the upcoming ASM Microbe 2018 conference in Atlanta.

Currently available to hospitals across the United States, the Karius Test reports the presence and abundance of microbial cfDNA. The test provides clinicians with a report of the amount of pathogen DNA found in a patient’s blood as compared to a reference range from asymptomatic adults, providing additional insights regarding the burden of infection given the clinical context. Clinicians are currently using the test to identify culture-negative or diagnostically-challenging infections in immunocompromised and critically-ill patients in various clinical scenarios, including sepsis1, endocarditis, febrile neutropenia, and patients who have received antibiotic pre-treatment2. In a study to be presented at the Karius Industry Showcase this week at ASM Microbe 2018, the Karius Test identified pathogens in sepsis patients more than three times as frequently as blood culture, and more often than blood culture and other microbiology tests combined3. The test also readily identifies deep infections that might otherwise require invasive biopsies, including invasive fungal infections4.

“We are helping infectious disease doctors and microbiologists identify some of their most challenging infections, particularly where current diagnostic methods are either limited, invasive or time-consuming,” said Dr. David Hong, Karius Vice President of Medical Affairs and Clinical Development, who will present study data at ASM on invasive fungal infections detected by the Karius Test in pediatric patients. “In my experience as a pediatric infectious disease physician, some of the most challenging clinical scenarios I encounter include invasive fungal infections in immunocompromised patients. Next-generation sequencing of cell-free plasma can rapidly and non-invasively identify fungal pathogens in immunocompromised pediatric patients, allowing for earlier, targeted treatment.”

Karius has the capability to readily expand the breadth of pathogen coverage through database enhancements as emerging pathogens are discovered and newly-relevant, high quality reference genomes become available. Clinicians can search for a specific pathogen or species using the Karius Pathogen List online.

Karius will be presenting at the following ASM Microbe sessions:

Friday, June 8, 2:00 p.m., Room A305
Dr. Timothy A. Blauwkamp, Chief Scientific Officer at Karius
Oral Abstract Presentation: Validation of A Microbial Cell-Free DNA Sequencing Test for Infectious Disease

Friday, June 8, 3:30 p.m., Room A305
David Hong, MD, VP Medical Affairs
Oral Abstract Presentation: Evaluation of the Karius Plasma Next-Generation Sequencing Test for Pathogen Detection in Pediatric Patients At Risk for Invasive Fungal Infection

Saturday, June 9, 11:00 a.m. to 1:00 p.m.
Exhibit and Poster Hall, Building B, Halls B2-B5
POSTER #382: Validation of A Microbial Cell-Free DNA Sequencing Test for Infectious Disease
Dr. Timothy A. Blauwkamp

Saturday, June 9, 12:00 p.m.
Booth 2422 on the Exhibit Hall floor
ASM Emerging Tech Talk
Mickey Kertesz, Chief Executive Officer at Karius

Saturday, June 9, 1:00 p.m., Exhibit Hall, Industry Showcase A
Clinical Application of the Karius Test – a Plasma Next-Generation Sequencing Test for Pathogen Detection

o Dr. Joseph M. Campos, Interim Chief of the Division of Laboratory Medicine at Children’s National Health System
Presentation: Clinical Experience with the Karius Test at Children’s National Medical Center
o Dr. Simone A. Thair – Biomedical Informatics Postdoctoral Research Fellow at Stanford University and SEP-SEQ study lead
Presentation: SEP-SEQ Trial – Determining the Etiology of Sepsis with the Karius Test
o Dr. Timothy A. Blauwkamp – Chief Scientific Officer at Karius
Presentation: Clinical Applications of the Karius Test

Sunday, June 10, 12:45 p.m. to 2:45 p.m.
Exhibit and Poster Hall, Building B, Halls B2-B5
POSTER #716: Evaluation of the Karius Plasma Next-Generation Sequencing Test for Pathogen Detection in Pediatric Patients At Risk for Invasive Fungal Infection
Dr. David Hong

Attendees can visit Booth 1215 to connect with the Karius team at ASM Microbe.

About Karius, Inc.
Karius is a life sciences company focused on transforming infectious disease diagnosis 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 unprecedented insight into the microbial landscape, providing clinicians with a comprehensive, quantitative test capable of identifying more than a thousand pathogens directly from blood and helping industry accelerate drug development. For more information, visit kariusdx.com and follow us on Twitter at @kariusdx.

References

1 Data presented at IDWeek 2017, 279 – The SEP-SEQ Trial – A Pilot Study Characterizing the Performance of a Novel Plasma Next-Generation Sequencing Assay to Detect Cell-Free Microbial DNA in Patients with Sepsis
2 Direct Detection and Quantification of Bacterial cell-free DNA in Patients with Bloodstream Infection (BSI) Using the Karius Plasma Next-Generation Sequencing (NGS) Test, IDWeek 2017
3 Data to be presented at ASM Microbe 2018, June 9: The SEP-SEQ Trial. Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay, Dr. Simone Thair
4 Data presented at ASM Microbe 2017, Session 266, Talk 8

* Results reported the next day for about 80% of samples received by 8:30 a.m. Monday to Saturday

Media Contact
Karius, Inc.
Denise Terry
media@kariusdx.com

Antenna Group
Sean Lenehan
karius@antennagroup.com
415-977-1918