Dive Brief:
- Liquid biopsy company Karius said Thursday it has raised $100 million to expand the use of a test designed to detect more than 1,000 pathogens in a blood sample.
- Karius said on its website that the test is authorized under the Clinical Laboratory Improvement Amendments of 1988, the regulatory pathway used for laboratory developed tests, as opposed to being OK’d for the U.S. market by the Food and Drug Administration. However, the FDA recently finalized a new rule to begin regulating lab developed tests.
- Karius said 400 U.S. hospitals are using the test, which uses genomic analysis and artificial intelligence to help physicians diagnose infections in immunocompromised patients. The series C financing positions Karius to try to serve demand for the laboratory developed test outside of hospital settings.
Dive Insight:
People who are immunocompromised, such as those who have recently received a bone marrow transplant, are at increased risk of infection. When patients present with symptoms of infection, doctors need to quickly identify the biological cause to provide effective, targeted treatment and minimize the use of broad-spectrum antibiotics.
Identifying the pathogen causing the symptoms is challenging. Patients may be infected with rarely seen pathogens, there are overlaps between the symptoms of different infectious diseases, and established tests such as blood culture can miss cases and delay treatment.
Metagenomic next-generation sequencing (mNGS) of pathogen nucleic acid has emerged as a potential way to accelerate diagnosis. However, authors of a 2021 study of the test in the journal Clinical Infectious Diseases argue that more studies of the technology’s real-world impact need to be conducted.
By detecting pathogen cell-free DNA from bacteria, viruses, fungi and eukaryotic parasites, the tests could enable physicians to find the cause of an infection even if they lack a hypothesis. Karius and IDbyDNA, which Illumina acquired in 2022, are among the companies in the field.
CEO Alec Ford said in a statement that the “additional $100 million will significantly enhance our capacity to deliver rapid diagnostic testing to more patients.” Khosla Ventures co-led the financing round with new investors 5AM Ventures and Gilde Healthcare.
Karius shared news of the financing alongside the results of a multi-center study of 257 hospitalized adults with pneumonia and active hematologic malignancies. Karius’ test detected 40% more cases when added to the standard of care.