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Karius Launches Karius Focus™ | BAL: A Comprehensive and Timely Solution for Diagnosis and Management of Suspected Infectious Pneumonia and Other Lung Infections Among Immunocompromised Patients

From a single blood sample, the Karius Test can non-invasively and rapidly detect over 1000 pathogens causing both deep-seated and bloodstream infections.

Karius

News & Press Releases

AI is trained to spot warning signs in blood tests

This new blood test could change everything for immunocompromised patients

Karius to Expand Agnostic Pathogen Detection Capability to RNA Genomes

Karius snares FDA breakthrough tag for genomic infectious disease blood test

Karius Test Receives FDA Breakthrough Device Designation

The New Era of Life Sciences 2024

)--Karius®, Inc., a leader in metagenomic sequencing for infectious disease diagnostics, announces the launch of Karius Focus | BAL, a microbial cell-free DNA test that helps physicians accurately identify the pathogens causing pneumonia and other lung infections. The product became available nationwide on April 28, 2025.

“Lung infections are common and often lethal among immunocompromised patients yet current diagnostic tests fail to identify a specific infectious cause in most cases,” says Dr. Brad Perkins, Chief Medical Officer, Karius. “Karius has demonstrated that our plasma-based test (Karius Spectrum™) significantly improves diagnostic yield among immunocompromised patients with pneumonia. We expect the Focus | BAL test to further improve diagnostic yield among immunocompromised patients who undergo bronchoscopy with bronchoalveolar lavage (BAL) for suspected pneumonia and other lung infections. The combination of Karius plasma- and BAL-based diagnostic tools, used alone or in combination, should substantially improve care.”

Utilizing the same microbial cell-free DNA technology as Karius Spectrum™, this test is designed to rapidly identify the etiology of lung infections and improve diagnostic yield over standard-of-care testing. With just 1 mL of BAL fluid, Karius Focus | BAL can detect and classify over 500 pathogens associated with lung infections—all within a single day of sample receipt.

Bronchoalveolar lavage (BAL) is a widely used procedure for evaluating patients with suspected lung infections, particularly in immunocompromised populations. Yet, standard-of-care testing frequently fails to identify the causative pathogen, often requiring multiple tests and leading to delays in care. Karius Focus | BAL addresses these diagnostic gaps by providing clinicians with a single, comprehensive answer—delivered quickly and conveniently.

“Karius Focus | BAL significantly advances pulmonary diagnostics by integrating rapid turnaround, extensive pathogen coverage, and clinical accuracy,” said Alec Ford, CEO of Karius. “Karius is committed to closing the gap in diagnostics for immunocompromised patients with suspected pneumonia and other lung infections to improve and save lives, and to return as quickly as possible the focus of care to their other underlying cause of illness.”

Karius Inc., a global leader in genomic diagnostics for infectious diseases, harnesses metagenomics, next-generation sequencing, and artiﬁcial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. Karius Spectrum™ and Karius Focus™ | BAL provides clinicians with actionable insights to enhance patient management, particularly in immunocompromised populations at high risk for severe infections. These Laboratory Developed Tests (LDT) are conducted in the company's CLIA-certified and CAP-accredited laboratory, delivering precise, timely, and clinically impactful results to healthcare providers nationwide.

 – Karius®, Inc. today announced it has been awarded a contract from the Division of Research, Innovation, and Ventures (DRIVe), under the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Valued over $600,000, the contract enables Karius to extend its current DNA pathogen detection capabilities to include RNA pathogen detection from a variety of human samples.


“We are delighted to partner with BARDA DRIVe in developing highly scalable tests that can rapidly identify any type of pathogen anywhere in the body,” said Tim Blauwkamp, Chief Scientific Officer and co-founder of Karius. “Our agnostic test for DNA pathogens has already served over 60,000 hospitalized patients, and this new project brings our vision of rapid, comprehensive diagnostics for every patient one step closer.” This contract follows a $100M Series C announcement earlier in the year to expand its Karius Test® beyond the 400 U.S. hospitals currently using it and to support research into the broader applications of Karius’ metagenomics technology. Additionally, Karius announced that the Karius Test has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.


To learn more about Karius visit kariusdx.com. To learn more about Karius’ contract with the Agnostic Diagnostics Program, please visit the BARDA website. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50124C00023.


Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 400 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt. 

A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification for multiple applications including pneumonia, endocarditis, invasive fungal infections, and infectious causes of febrile neutropenia and fever of unknown origin. The Karius Test also has been incorporated into the diagnostics recommendations in the 2023 Duke-ISCVID Criteria for Infective Endocarditis.


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Consort Partners for Karius
kariusdx@consortpartners.com

Karius Secures BARDA Contract to Expand Agnostic Detection of Pathogens

 a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

“The Karius Test is commercially available nationwide as a laboratory developed test. We are seeking FDA marketing authorization of the Karius Test for lung infections in immunocompromised patients because improved diagnostic tests are urgently needed for these patients,” stated Brad Perkins, M.D., Chief Medical Oﬃcer of Karius. “As noted in the 

American Thoracic Society (ATS) Workshop Report for Immunocompromised Host Pneumonia: Deﬁnitions and Diagnostic Criteria

 lung infections have high morbidity and mortality in immunocompromised patients, which is why advances in technologies like metagenomic sequencing used for the Karius Test are vital in improving the diagnosis and treatment of these patients.”

The 

 is a voluntary program for certain medical devices and device-led combination products that provide for more eﬀective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these innovative medical devices.

Clinical data that support the use of the Karius Test in pneumonia for immunocompromised patients includes the results of the 

 study, where results showed that the Karius Test increased the relative yield for detection of a probable cause for pneumonia by 40%.

 Additionally, the Karius Test identiﬁed clinically relevant non-pneumonia infections in 39% of subjects.

 These additional data highlight the ATS Workshop Report observation that "the existing clinical deﬁnition of pneumonia is syndromic and lacks speciﬁcity," 1 and support the value of approaches that are agnostic to both the pathogen and the site of infection like the Karius Test.

“Recent data from several trials indicate that the Karius Test oﬀers a speedy, accurate, and sensitive diagnosis of infectious causes of pneumonia and related infections in immunocompromised patients. As such, it represents a major advance in the care of patients with hematologic cancers and those undergoing stem cell transplantation,” said Norman E. Sharpless, MD; former Director of the National Cancer Institute and Acting Commissioner of the Food and Drug Administration, and member of the Karius board.

New data from the PICKUP study on the cost-eﬀectiveness of the Karius Test will be presented at the 

American Thoracic Society Annual Meeting 2024

 International Conference.

To learn more about Karius Test diagnostic applications for infectious disease, including pneumonia, endocarditis, invasive fungal disease, febrile neutropenia, and fever of unknown origin, visit us at 

1 Cheng et al, Annals of the American Thoracic Society, 2023
2 Bergin SP, et al. Clinical Infectious Diseases. October 2023

Karius Inc., a global leader in genomic diagnostics for infectious diseases, harnesses metagenomics, next-generation sequencing, and artiﬁcial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis.

Karius Test® is a Laboratory Developed Test (LDT) performed in a CLIA-certiﬁed and CAP-accredited laboratory to perform high-complexity clinical laboratory testing. The Karius Test®, used in over 400 healthcare institutions across the United States, identiﬁes more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt.

A landmark study in the 

 found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identiﬁcation.



Karius Test® Receives FDA Breakthrough Device Designation to Aid in the Diagnosis of Infectious Disease

, Inc., a world leader in genomic diagnostics for infectious disease, today announced it has secured $100 million in Series C funding. The round was co-led by Khosla Ventures and new investors 5AM Ventures and Gilde Healthcare. Also investing was new investor Seventure Partners, and existing investors Softbank Vision Fund 2, General Catalyst, HBM Healthcare Investments, Blue Water Life Sciences, Innovation Endeavors, Waycross Ventures, and others.

This investment will enable Karius to extend its reach beyond the 400 U.S. hospitals currently using the Karius Test®, an infectious disease diagnostic test that utilizes genomic analysis and artiﬁcial intelligence to detect over 1,000 pathogens from a single blood sample. The funding enables Karius to address increasing demand from healthcare providers to expand access to the Karius Test beyond the hospital setting. Additionally, it will support research into the broader health implications of Karius’ microbial cell-free DNA technology beyond infectious diseases.

“Every minute in the U.S., ﬁve cancer patients are admitted to the hospital due to infections—conditions that are often overshadowed by their primary diagnosis but are equally lethal, leading to nearly 1,000 deaths daily,” said 

. “This worrying reality emphasizes a critical and frequently overlooked gap in our healthcare system: the urgent need for faster diagnostic solutions. At Karius, we confront this challenge head-on. The Karius Test can reduce the time required to identify the cause of infections, as every minute counts for cancer patient survival. This additional $100 million will signiﬁcantly enhance our capacity to deliver rapid diagnostic testing to more patients, where faster treatment saves more lives and signiﬁcant healthcare resources.”



Karius also announced the appointment of three new board members joining recent additions, Dr. Norman Sharpless M.D., former National Cancer Institute Head, and Elizabeth O'Farrell, former Eli Lilly executive:

Alex Morgan, M.D., Ph.D., Partner at Khosla Ventures

Joep Muijrers, Ph.D., General Partner at Gilde Healthcare

Andrew Booth, Venture Advisor to 5AM Ventures, and CFO of AbCellera Biologics

"Investing in Karius addresses critical gaps in healthcare diagnostics,” stated 

. “Traditional methods can be slow and can contribute to overuse of antibiotics, particularly risky for immunocompromised patients and fueling Antimicrobial Resistance (AMR). Precisely identifying pathogens allows for targeted treatment, minimizing the use of broad-spectrum antibiotics and reducing the risk of AMR proliferation. This investment aligns with our commitment to advancing technologies for better public health outcomes."

“We are thrilled to partner with Karius and to support the company in its journey to help deliver better care at lower cost to some of the most vulnerable patients out there,” added 

Joep Muijrers, General Partner at Gilde Healthcare

.

“Karius’ strong revenue and growth illustrates how impactful the Karius Test is to clinical care. We are proud to co-lead the company’s Series C as Karius expands into new markets and moves to proﬁtability,” added 

Andrew Booth, Venture Advisor, at 5AM Ventures

.

“Over the years, we’ve witnessed ﬁrsthand the repeat impact Karius has made on patient management across numerous clinical settings,” added 

Vali Barsan, M.D., Karius Board Member and investor for SoftBank Investment Advisers

. “Alongside our new as well as existing investors, we’re proud to extend our partnership with the Karius team as they continue to scale precision metagenomics for more rapid and deﬁnitive diagnostics that enable better patient outcomes.”

Karius’ Series C ﬁnancing coincides with the positive results from the PICKUP

 trial, a landmark multi-center study enrolling 257 hospitalized adults with pneumonia and active hematologic malignancies across 10 leading medical centers, including Duke University Health, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and University of California, San Francisco Medical Center. When added to the standard of care workup, the Karius Test detected 40% (21/52) more infections with a potential to change medical management for 81% (17/21) of these cases, demonstrating a signiﬁcant additive diagnostic value in patients with blood cancers or bone marrow transplants. This ﬁrst-of-its-kind study underscores the Karius Test's potential to transform the diagnostic journey and patient care.

“We’ve done extensive due diligence, and the value that Karius brings to patients and the healthcare system at large is abundantly clear,” 

said Isabelle De Cremoux, CEO and Managing Partner of Seventure Partners

. “The clinical evidence clearly shows its potential to help more patients. We’re excited to join Karius at such a key strategic time for the company as they grow to support the wider commercialization of the Karius Test.”

Learn more about Karius’ solutions for infectious disease diagnostics by visiting 

Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics, next-generation sequencing, and artiﬁcial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 400 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identiﬁes more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt.

A landmark study in the 

 found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identiﬁcation. The Karius Test also has been incorporated into the diagnostics recommendations in the 

2023 Duke-ISCVID Criteria for Infective Endocarditis

1.	Bergin SP, et al. Clinical Infectious Diseases. October 2023


Karius Raises $100M Co-Led by Khosla Ventures, 5AM Ventures and Gilde Healthcare, to Expand Access to Advanced Genomic Diagnostics in Infectious Disease, Addressing Antimicrobial Resistance Crisis

 - A pivotal multi-center study published in Clinical Infectious Diseases demonstrates the effectiveness of the Karius Test®, a blood test based on metagenomics next generation sequencing of microbial cell-free DNA, by increasing the identification of pathogens causing pneumonia in immunocompromised patients by 40% (20/52) when combined with usual care diagnostic testing

. This first-of-its-kind PICKUP Study–a collaborative effort among ten leading medical institutions including Duke University Health System, University of Pittsburgh Medical Center, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center, City of Hope, Tulane Medical Center, University of California, San Francisco Medical Center, University of Colorado Denver, Weill Cornell Medicine, and Memorial Sloan Kettering Cancer Center–demonstrated the additive diagnostic value of the Karius Test in managing pneumonia patients with blood cancers.

“Pneumonia commonly complicates hematopoietic cell transplantation and treatment of hematologic malignancies, yet current diagnostic standards identify a causative pathogen in less than half of our patients undergoing bronchoscopy and extensive noninvasive testing,” said Dr. Stephen Bergin, Duke Clinical Research Institute faculty and Principal Investigator for the PICKUP Study. “Often clinicians must weigh the risks of invasive procedures in medically fragile patients with an anticipated low diagnostic yield. The PICKUP Study significantly advances our understanding of how noninvasive plasma microbial cell-free DNA (mcfDNA) sequencing can enhance management of pneumonia.” Pneumonia is a leading cause of death among patients currently undergoing treatment for blood cancer, as they are often at elevated risk of infection throughout their treatment

Identifying the specific cause of pneumonia in patients with blood cancers who are often severely immunocompromised is difficult and critically important to successful treatment. “This well-designed clinical trial conducted at leading academic centers shows that the Karius Test is highly valuable in immunocompromised patients with suspected infection,” said Dr. Ned Sharpless, former Director, National Cancer Institute, and newest Karius board member. “The ability to identify the causal pathogen with true urgency is critical in this patient population, and more rapid diagnosis through use of the Karius Test will reduce suffering and death in these vulnerable patients.”

The Study, “Pneumonia in the ImmunoCompromised – Use of Karius Test for the Detection of Undiagnosed Pathogens (PICKUP),” enrolled 257 hospitalized adults with pneumonia and active hematologic malignancies, had recently undergone a hematopoietic cell transplant, or were receiving immunosuppressive therapy for active graft versus host disease.

“Adding this novel platform to current standards of care significantly improved causative pathogen identification. Future PICKUP Study publications will evaluate the impact of plasma microbial cell-free DNA sequencing on time to diagnosis, detection of co-infections, and potential avoidance of invasive procedures,” said Dr. Stephen Bergin. This primary study endpoint measured the additive diagnostic value of the Karius Test, defined as the percent of patients where the Karius Test identified the cause of pneumonia for whom all usual care testing was negative within 7 days of admission through adjudication. Results showed that the Karius Test identified the probable cause of pneumonia in 12% (21/173) of patients (P<0.001, 95% confidence interval 7.7 yo 18%), when all usual care testing, including bronchoscopy failed to identify a probable cause of pneumonia. The study also evaluated and found that antimicrobial therapy could have been optimized among 81% (17/21) of patients in whom the Karius Test exclusively identified a probable cause of pneumonia

. In several instances, the Karius Test also identified probable causes of pneumonia when all usual care testing failed to find hard-to-identify pathogens such as 

Rhizomucor pusillus, Nocardia cyriacigeorgica, Legionella

. Editors of Clinical Infectious Diseases, a journal published by the Infectious Diseases Society of America (IDSA) concluded, "mcfDNA sequencing is likely to bring added diagnostic value for some heme/STC [hematologic malignancy/stem cell transplant] patients with pneumonia." 

“These patients have much to gain through an improved etiologic diagnosis, and the better and more directed treatment of these infections that make this possible,” said Brad Perkins, Chief Medical Officer at Karius. “This is not only beneficial in the avoidance of the direct morbidity and mortality associated with these infections (26.6% of our enrolled patients died during this study) but in also gaining earlier and uninterrupted access to in-many-cases increasingly life-saving treatments for their underlying disease, in this case hematologic malignancies.”


Schuster MG, et al. Open Forum Infect Dis. 2017;4(2):ofx050

Lucena CM, Torres A, Rovira M, et al. Bone Marrow Transplant. 2014;49(10):1293-9.

Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 300 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt. A landmark study in the 

 found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification. The Karius Test also has been incorporated into the diagnostics recommendations in the 

Karius Test® Improves the Diagnosis and Management of Pneumonia in Patients Undergoing Treatment for Blood Cancer

– Karius®, Inc. a world leader in liquid biopsy for infectious diseases, is announcing the appointment of two healthcare veterans to its Board of Directors: Norman (Ned) Sharpless, M.D. and Elizabeth (Liz) O’Farrell.

Sharpless, highly regarded for his contributions to healthcare leadership and patient-centric innovation, served as the Director of the National Cancer Institute (NCI) from 2017 to 2022. His achievements include the prioritization of the Childhood Cancer Data Initiative and the Cancer Moonshot program, along with the introduction of the NCI's Equity and Inclusion Program in response to the 2020 calls for racial justice. In 2019, Sharpless served as the U.S. Food and Drug Administration's (FDA) Acting Commissioner for seven months. His tenure focused on the opioid crisis, youth e-cigarette use, new drug approvals, and leading the FDA's COVID-19 response, including emergency authorization of vaccines and treatments, before resuming his role as the director of NCI.


Karius CEO, Alec Ford, stated, "Ned brings an important perspective to our mission to improve treatment for those most at risk from infectious diseases. His deep understanding of the interplay between cancer and infectious diseases, particularly in the context where infections are a leading cause of morbidity and mortality in cancer patients—accounting for up to 50% of deaths—is invaluable. He recognizes that to win the war on cancer, we must also develop more effective strategies to address infections in these patients."


Former Eli Lilly executive, O'Farrell, joins the Board with more than two decades of global responsibility within a multinational public company. Known for fostering a positive work culture and driving transformative change through collaboration, her financial and business acumen is an asset to Karius.


"Liz’s impressive track record and visionary leadership in global finance make her a significant addition to our board," added Ford. "She has demonstrated the ability to identify areas for improvement and drive transformative changes throughout her career. Together, Ned and Liz will be instrumental as we strive to further our work in infectious disease diagnostics through genomics."


Sharpless brings his extensive knowledge of oncology and genetic research to enhance Karius' research and development efforts. Chairing the Audit Committee, O’Farrell's financial and operational expertise will play a key role in strategic growth, reinforcing Karius' global leadership position in infectious disease detection. 

“Infection causes so much suffering in patients with cancer, and our ability to treat infection remains imperfect,” Sharpless said. “I am excited by the Karius approach to help clinicians diagnose infectious disease, relying on next-generation sequencing and artificial intelligence to identify deadly pathogens sooner and with much greater sensitivity than standard approaches. I believe this technology can transform the management of infection in patients with cancer and other diseases, and am excited to play a role in its development as a member of the Board.” “I’m very excited to have the opportunity to join the Karius Board of Directors at such an exciting time for the company,” O’Farrell said. “I look forward to leveraging my financial and operational experience to support the Karius team in their mission to improve the lives of patients with undiagnosed infectious disease.”


Dr. Sharpless most recently held the position of the Director of the National Cancer Institute (NCI), spearheading initiatives to advance cancer research, prevention, and treatment. Previously, he served as the Acting Commissioner for Food and Drugs at the U.S. Food and Drug Administration(FDA) in 2019 and as the director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center from 2014 to 2017. Dr. Sharpless began his clinical training at Massachusetts General Hospital and the Dana-Farber Cancer Institute and co-founded G1 Therapeutics and Jupiter BioVentures. Dr. Sharpless is a graduate of the University of North Carolina School of Medicine where he is now the Professor of Cancer Policy and Innovation.


Ms. O’Farrell’s successful career spanned 24 years at Eli Lilly, where she held several executive management positions including General Auditor, CFO of Lilly USA, and SVP of Policy and Finance. Her final role before retiring in 2017 was as Chief Procurement Officer and Head of Global Shared Services. She possesses a wide range of experience in accounting and reporting, FP&A, operational finance and audit. Elizabeth also serves as the Audit Committee Chair on two other Boards, namely Geron Corp (where she also serves as Lead Independent Director) and Lensar Inc. Additionally, she holds the position of Chairperson at PDL BioPharma (private) and serves as a Board Director, audit committee member and compensation committee member at Genmab A/S. Elizabeth earned an MBA in Management Information Systems and a BA in Accounting from Indiana University Bloomington.


Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 300 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt. A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification. The Karius Test also has been incorporated into the diagnostics recommendations in the 2023 Duke-ISCVID Criteria for Infective Endocarditis.