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Karius Next-Generation Sequencing Blood Test for Infectious Disease Used in a Nohla Phase 2 Cellular Therapy Clinical Trial

Karius, Inc., a life sciences company transforming infectious disease diagnostics with genomics, today announced that they have entered into an agreement with Nohla Therapeutics, Inc. to use the Karius next-generation sequencing (NGS) plasma test for pathogen detection in Nohla’s Phase 2 randomized trial evaluating the company’s lead product, NLA101, in acute myeloid leukemia (AML) patients with chemotherapy-induced neutropenia.

The Karius test for infectious diseases detects microbial cell-free DNA (cfDNA) in plasma from more than a thousand pathogens from a single blood draw in one day using NGS, including bacteria, DNA viruses, fungi and protozoa. The test enables clinicians as well as biopharma partners, such as Nohla, to easily monitor immunocompromised patients for infections. Nohla is using the Karius test to evaluate infections in adult patients with chemotherapy-induced neutropenia who have received their novel cellular therapy NLA101. NLA101 is a universal, off-the-shelf stem and progenitor cell therapy that has the potential to provide short-term hematopoietic recovery and also may provide long term immunologic and clinical benefits. The Karius test provides a quantitative assessment of pathogen DNA in both clinically-documented infections and subclinical infections.

"We're pleased to work with Nohla Therapeutics to provide quantitative monitoring of pathogen DNA to aid in the assessment of patients receiving NLA101 in this trial,” said Dr. David Hong, Karius Medical Director. “Patients undergoing intensive chemotherapy have a higher risk of infectious complications which often are not detected by standard microbiologic techniques. Our comprehensive platform for pathogen detection covers a broad range of over a thousand bacteria, DNA viruses, and eukaryotic pathogens including yeasts and molds. We are excited to work with Nohla as they advance patient care in patients with hematological malignancies.”

This agreement further demonstrates the potential of Karius’ innovative infectious disease platform for the development of novel therapeutics. Karius will provide laboratory testing and analysis services to support Nohla’s Phase 2 Trial, entitled “A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia”. Incorporating the Karius test into the Phase 2 study will enhance the understanding of NLA101’s potential effectiveness in preventing infections.

"The Karius Next Generation Sequencing cell-free microbial DNA test will augment our Phase 2 clinical trial and allow us to evaluate how NLA101 can potentially prevent infections in neutropenic acute myeloid leukemia patients receiving high dose chemotherapy," said Colleen Delaney, MD, Founder and Chief Medical Officer of Nohla. "We look forward to the results of this study and evaluating NLA101’s potential to improve patient outcomes in this high-risk population."

About the Karius Test

The Karius Digital CultureTM Test uses next-generation sequencing (NGS) and analytics for the broad and rapid detection of microbial cell-free DNA through a standard blood draw. Unlike conventional culture and panel testing methods that test for a narrow range of pathogens, the Karius test can detect over a thousand pathogens including bacteria, DNA viruses, and eukaryotic organisms such as yeasts, molds, and protozoa. Results are typically available within one day of sample receipt. Through Karius’ CAP-accredited and CLIA-certified laboratory service, the test empowers doctors to diagnose infections quickly while sparing patients the pain and risk of invasive biopsies, and provide rapid and more targeted treatment.

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