Karius said today its next-generation sequencing (NGS) plasma test for pathogen detection will be used by Nohla Therapeutics will use in its Phase II trial evaluating the company’s lead product, NLA101, in acute myeloid leukemia (AML) patients with chemotherapy-induced neutropenia.
The value of the clinical collaboration was not disclosed.
Karius will provide lab testing and analysis services to support Nohla’s Phase II trial (NCT03301597). Karius’ Digital Culture™ Test for infectious diseases is designed to detect microbial cell-free DNA (cfDNA) in plasma from more than 1,000 pathogens from a single blood draw in one day using NGS—including bacteria, DNA viruses, fungi and protozoa.
The test is intended to enable clinicians, and biopharmas to easily monitor immunocompromised patients for infections. Results are typically available within one day of sample receipt, according to Karius.
The Karius test provides a quantitative assessment of pathogen DNA in both clinically-documented infections and subclinical infections. Nohla is using the Karius test to assess infections in adult patients with chemotherapy-induced neutropenia who have received NLA101, a universal, off-the-shelf stem and progenitor cell therapy designed to provide short-term hematopoietic recovery, with the potential for long term immunologic and clinical benefits.
“Our comprehensive platform for pathogen detection covers a broad range of over a thousand bacteria, DNA viruses, and eukaryotic pathogens including yeasts and molds,” Karius Medical Director David K. Hong, M.D., said in a statement. “We are excited to work with Nohla as they advance patient care in patients with hematological malignancies.”
Added Colleen Delaney, M.D., Nohla founder and CMO: “The Karius Next Generation Sequencing cell-free microbial DNA test will augment our Phase II clinical trial and allow us to evaluate how NLA101 can potentially prevent infections in neutropenic acute myeloid leukemia patients receiving high dose chemotherapy.”