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

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– 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.

Karius Inc. Adds Dr. Norman Sharpless, Former National Cancer Institute Head, and Elizabeth O’Farrell, Eli Lilly Veteran, to its Board of Directors

 – Karius®, Inc. a world leader in liquid biopsy for infectious diseases, has announced the inaugural inclusion of the Karius Test® in the 2023 Duke-ISCVID Criteria for Infective Endocarditis by the International Society of Cardiovascular Infectious Diseases (ISCVID)

. Using microbial cell-free DNA from a single blood draw, the Karius Test can detect over 1,000 pathogens, including pathogens responsible for infective endocarditis.

Infective endocarditis is a serious condition that results from an infection leading to inflammation of the heart's lining, valves, or blood vessels. Untreated, it is uniformly fatal. Traditional diagnostic methods, such as blood cultures, can take several days

 to yield results, often fail to identify the underlying pathogen causing an infection,

 and positivity rates are decreased due to prior antimicrobial therapy

. The Duke Criteria was introduced 30 years ago by leading medical experts to enhance and standardize the diagnosis of infective endocarditis. The Criteria has been periodically updated to incorporate technological advances and research discoveries.

The latest version of the Criteria – produced by a working group of 25 subject matter experts from five continents and six infective endocarditis-related subspecialties – has for the first time included hypothesis-free metagenomics sequencing, the technology behind the Karius Test, for fast identification of hard-to-detect pathogens. Specifically, the new Duke-ISCVID Criteria recognizes the high importance of this type of sequencing found in the Karius Test when blood cultures fail to identify a causative pathogen. This acknowledges the Karius Test’s ability to quickly detect difficult-to-diagnose causes of endocarditis such as 

. The working group based their recommendations on multiple studies demonstrating the ability of the Karius Test to rapidly detect these pathogens within a day of specimen receipt. For example, studies have shown that the Karius Test has a higher diagnostic yield than standard testing for identifying causative pathogens in patients with endocarditis (80% yield for Karius Test vs. 30% for blood culture

, n=10) and that the Karius Test can detect the causative pathogens over a much longer period than blood culture (38.1 days for the Karius Test versus 3.7 days for blood culture

 and challenges in diagnosis increases risk for poor health outcomes,” said Brad Perkins, MD, Chief Medical Officer of Karius. “These updated guidelines reflect our real-world experience with use of the Karius Test for infective endocarditis as an important tool for physicians to rapidly and more accurately diagnose and manage infective endocarditis as well as other serious infections, particularly among immunocompromised patients. We appreciate the efforts of these experts for recognizing the growing importance of plasma microbial cell-free DNA metagenomic sequencing as an important new diagnostic test for infective endocarditis patients.”

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.

 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

For additional information regarding the diagnostic application of the Karius Test for endocarditis, please go 

__________________________________________

The 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis: Updating the Modified Duke Criteria

, 2023;, ciad271, https://doi.org/10.1093/cid/ciad271
2. Liesman RM, Pritt BS, Maleszewski JJ, Patel R. 

Laboratory Diagnosis of Infective Endocarditis

. 2017 Sep;55(9):2599-2608. doi: 10.1128/JCM.00635-17.
3. Vogkou CT, et al. 

. 2016 Aug;35(8):1227-45.
4. Eichenberger EM, et al. 

. 2021 May 1;40(5):486-488.
6. Chen H, Zhan Y, Zhang K, Gao Y, Chen L, Zhan J, Chen Z, Zeng Z. 

The Global, Regional, and National Burden and Trends of Infective Endocarditis From 1990 to 2019: Results From the Global Burden of Disease Study 2019

. Front Med (Lausanne). 2022 Mar 9;9:774224. doi: 10.3389/fmed.2022.774224.

Karius Test®, a Liquid Biopsy for Infectious Diseases, Incorporated into Diagnostics Recommendation in the 2023 Duke-ISCVID Criteria for Infective Endocarditis

REDWOOD CITY, Calif., and CAMBRIDGE, Mass., 

April 11, 2023 – Karius®, the world leader in liquid biopsy for infectious diseases, and eGenesis, Inc. a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, today announced a partnership through which the two companies will develop infectious disease diagnostics for xenotransplantation initially from porcine to primates and ultimately to humans. Through the partnership, Karius will leverage its platform to power the detection and quantification of pathogens with potential to occur in porcine organ donors.

Karius’ expanded platform for detection of microbial cell-free DNA will power the surveillance and diagnosis of potential infection in both the porcine organ donor and recipient, pre- and post-transplant.  Karius and eGenesis will collaborate in the development of this expanded platform and plan to complete this work by early 2024.

More than 100,000 people in the U.S. wait on the organ transplant list each year, and many more never get approved to be on the waiting list. An estimated 6,000 of these patients will die each year before they receive an organ transplant. The field of xenotransplantation has evolved to meet this growing demand, with companies working to genetically modify animal-derived organs for successful transplantation into humans. While great advancements have been made in recent years, infection is still a major threat.


Mitigating the risk of xenogeneic disease transfer is a core tenet of eGenesis’s approach to xenotransplantation. The company’s proprietary eGenesis Genome Engineering and Production (EGEN™) Platform leverages cutting-edge gene editing technologies to inactivate all detectable copies of endogenous retrovirus sequences within the porcine genome to prevent the virus from being passed from the organ donor to the recipient.


“While we are taking numerous measures to ensure our porcine donors are free from infectious agents, the ability to broadly monitor for infection transmission between species is important for ensuring the safety of xenotransplantation,” said Michael Curtis, Ph.D., Chief Executive Officer at eGenesis. “With our gene-editing technology, we have an unprecedented ability to engineer human compatible organs to address the organ shortage, and this partnership is a key step in our goal to make xenotransplantation safe.”

"We are excited to partner with eGenesis to accelerate the availability of safe xenotransplantation for the many people and families who may benefit from this important progress," said Brad Perkins, M.D, Chief Medical Officer at Karius.  "Patients who receive solid organ transplants regardless of source are at high risk for varied causes of infection, and can particularly benefit from Karius' unbiased, rapid, and non-invasive detection of pathogens."

Early in 2022, Karius’ technology was able to observe microbial cell-free DNA originating from a porcine pathogen in a patient who underwent the first xenotransplant, as published in New England Journal of Medicine. The porcine cytomegalovirus was consistently detected over 60 days post transplant, through serial testing, which was later confirmed by orthogonal technologies.

Karius’ technology employs an unbiased approach to detecting pathogens and offers a versatile and adaptable platform that can be modified to include new pathogens of both human and pig origin.

“One of the fundamental advantages of our technology lies in its differentiated ability to provide a wide lens into the organisms that may threaten patients, regardless of their origin,” said Sivan Bercovici, Chief Technology Officer at Karius. “The expansion into infectious disease diagnostics in xenotransplantation provides another proof point for our platform’s plasticity through data and AI.”

Karius, Inc., the world leader in liquid biopsy for infectious diseases, harnesses genomics and AI to transform infectious disease diagnostics. The Karius Test ® is a lab developed test which enables rapid and non-invasive detection of more than 1,000 pathogens from a single blood draw. Through the use of its test, Karius aims to improve patient outcomes, support antimicrobial stewardship efforts, and reduce invasive diagnostic use. The company today is focused on transforming the diagnosis of infections in immunocompromised patients to address the more than 800 infection related deaths that occur daily in cancer patients across the US. For more information, visit 

eGenesis is leveraging a genome engineering-based approach in the development of safe, effective and transplantable organs. The company’s EGEN™ platform is the only technology of its kind to address both viral risk and cross-species molecular incompatibilities. eGenesis has demonstrated durable preclinical success to date and is advancing development programs for kidney transplant, pediatric and adult heart transplant, extracorporeal liver perfusion and islet cell transplant. Learn more at www.egenesisbio.com.

Karius and eGenesis Partner to Help Accelerate Xenotransplantation for Patients in Need of Organ Transplants

, the world leader in liquid biopsy for infectious diseases, today announced a partnership with Capstone Health Alliance, a group purchasing organization focused on supply chain savings in hospitals and other organizations, to streamline patient access to the Karius Test

. The Karius Test is a lab developed test that can non-invasively and rapidly detect 1,000 + pathogens throughout the body from a single blood sample. Through the partnership, doctors at over 265 Capstone member hospitals across the U.S. can now more easily order the Karius Test for patients harboring hard-to-diagnose infections.

Capstone and Karius are focused on expanding access to quality medical care – especially for patients at high risk, such as those with compromised immune systems. There will be nearly 3 million hospitalizations this year in the U.S. alone from infections in the immunocompromised1. For these patients, infections can be particularly dangerous, and targeted early treatment is key to a positive clinical outcome.

“We are thrilled to partner with Capstone Health Alliance to accelerate access for patients to our metagenomic infectious disease test,” said Brad Perkins, MD, Chief Medical Officer of Karius. “With better access to the Karius Test, we’re excited for the opportunity to get fast, accurate tools into the hands of clinicians to empower earlier diagnosis and treatment of potentially life-threatening infectious diseases.”

The partnership will broaden institutional access to microbial cell-free metagenomics technology used by the Karius Test, which is currently being utilized across institutions nationwide, including children’s hospitals and transplant centers. Clinical evidence has demonstrated that the Karius Test helps clinicians diagnose bloodstream

“The Karius Test is a much-needed addition to a doctors’ toolkit against infectious disease, especially now that several potentially deadly infections with overlapping symptoms are making a comeback,” Robin Lincoln, Capstone’s Chief Contracting Officer, said. “Capstone can provide easier access to this platform to over 265 hospitals representing 36,000 licensed beds in our alliance. We are pleased to partner with such a reputable company as Karius to work together to broaden the awareness of this potentially life-saving test option.”

, facilities within the Capstone network have already begun using the Karius Test to identify rare infections including peritoneal tuberculosis and tularemia, as well as species of 

This week at the American Society of Microbiology Microbe 2022 Meeting, Karius will be presenting a data synthesis of pathogens detected in 15,165 patients, which represents the largest testing cohort of patients in which plasma microbial cell-free DNA has been identified and quantified.

1 Claims-based analysis from Clarify Health, 2021
2 Armstrong A., et al. Pediatr Blood Cancer. 2019;66(7):e27734.
3 Hong D., et al. Diagn Microbiol Infect Dis. 2018;92(3):210-213.
4 Rossoff, et al. Open Forum Infect Di. 2019;6(8):ofz327.

Karius is a life sciences company focused on generating genomic insights for infectious diseases with a non-invasive blood test that helps clinicians make rapid treatment decisions. By mapping each patient’s microbial landscape from a single blood draw, Karius envisions a world where infectious disease is no longer a major threat to human health.

Capstone Health Alliance is a group purchasing alliance of healthcare and non-healthcare members that delivers cost savings through the power of aggregation and collaboration. Based in Fletcher, North Carolina, Capstone’s membership includes 265 hospitals representing more than 100 health systems across 24 states and represents over $10 billion in acute care supply chain spending. Capstone also represents over 25,000 non-acute and business & industry members. Capstone delivers quantifiable savings and actionable data that enable better purchasing decisions for our members. In addition to cost savings initiatives, Capstone members collaborate to share best practices all with the intent of improving cost, quality, and outcomes.

Karius® Partners with Capstone Health Alliance to Widen Patient Access to Liquid Biopsy Test for Infectious Diseases

, the world leader in liquid biopsy for infectious diseases, announced today the addition of two key executives to best position the company for continued growth. Bill Quirk, who most recently served as Chief Financial Officer at Freenome, is joining Karius in the same capacity, and Steve Malaska, most recently the General Counsel at Dascena, Inc., has been named its Chief Legal Officer.

Quirk’s financial experience includes extensive success raising capital on Wall Street for leading diagnostics and life sciences tools companies. He spent nearly 20 years as an award-winning analyst at RBC Capital Markets and Piper Sandler, leading the healthcare research team while going in-depth on the molecular diagnostics industry and pioneering efforts in the fledgling synthetic biology market. At Freenome, Quirk oversaw one of the largest Series C raises in the diagnostics industry.

”With increased momentum in our commercial operations, it is a great time to join this tremendous team working towards life-changing improvements to diagnosing infectious diseases,” Quirk said, “Karius has that unique combination of technology, mission, and people that set us up for long term success.”

Malaska brings more than 30 years of intellectual property, legal and management experience in the diagnostic, biotech, pharma, and technology industries to his position, including his role as co-founder and CEO of Kota Biotherapeutics. Prior to his time at Dascena, he held senior leadership and General Counsel stints at Intellectual Ventures, Ceptyr and Immunex Corp., and was a patent attorney for multinational pharmaceutical company Hoffman La-Roche.

“I am excited to join Karius at this critical juncture of the company as it builds its commercial operations for the liquid biopsy Karius TestTM and expands its industry-leading capabilities in diagnosing pathogens” Malaska said. “Karius’s technology will change outcomes in a positive way for patients impacted by a number of different diseases and I look forward to contributing my experience and expertise to those efforts.”

“The Karius team is very fortunate to have Bill and Steve joining our organization right now. Our rapid growth and expansion will benefit significantly from their experience and their leadership will help drive many of our most important decisions in the years ahead”, Alec Ford, CEO of Karius said.

The appointments conclude a strong year of achievements for Karius, which is now offering the Karius TestTM to hospitals across the country. The company received a first-in-class approval for its Karius Test for pathogen detection from the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP), expanding access to critical infectious disease testing for patients in New York. The Karius Test is a liquid biopsy that can non-invasively and rapidly detect more than 1,000 pathogens from a single blood sample for infections located throughout the body. The Karius Test was also recently recognized as “Infectious Disease Testing Solution of the Year” at the 2021 BioTech Breakthrough Awards.

Karius is a life sciences company focused on generating genomic insights for infectious diseases with a non-invasive blood test that helps clinicians make rapid treatment decisions. By mapping each patient’s microbial landscape from a single blood draw, Karius moves closer to a vision of a world where infectious disease is no longer a major threat to human health.

Karius Prepares for Further Growth with New Chief Financial Officer, Chief Legal Officer Appointments

, the world leader in liquid biopsy for infectious diseases, has been selected as the winner of the “Infectious Disease Testing Solution of the Year” award, for its ground-breaking diagnostic technology, the Karius TestTM, at the inaugural BioTech Breakthrough Awards. The awards program was initiated this year by 

, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products, and services around the globe, with the aim of performing the most comprehensive evaluation of life sciences and biotechnology tools, services and companies today.

The BioTech Breakthrough Awards honors excellence and recognizes the creativity, hard work, and success of companies, technologies, and products in the life sciences and biotechnology industry. This year’s program attracted more than 1,200 nominations from over 12 different countries throughout the world. The Karius Test was chosen as a breakthrough innovation in the field of infectious diseases. The test has the ability to non-invasively identify more than 1,000 clinically relevant pathogens from a simple blood draw, within a single day of receipt. No other commercially available test is capable of this type or breadth of detection for infectious diseases.

“We are profoundly grateful for this award from BioTech Breakthrough. To be one of their first winners is a true honor. We will continue to advance diagnostic science and technology in the fight against infectious diseases,” said Alec Ford, CEO of Karius. “With the Karius Test, physicians have a new and important tool to help reduce the typical trial-and-error method of diagnostic testing for infectious diseases. For the most vulnerable patients, getting the right diagnosis in a timely manner can sometimes be the difference between life and death.”

The Karius Test is designed to be fast, accurate, and non-invasive. The test only requires 5 mL of blood to detect the pathogen(s) likely causing an infection because it’s based on microbial cell-free DNA (mcfDNA). Even when an infection is localized deep in the body, mcfDNA can be detected in the blood. Karius leverages the latest in genomics and AI to make sense of massive amounts of DNA data, teasing out specific microbial signatures tied to an infection. The result is a clear, accurate picture of the likely pathogen causing an infection.

“One of the most common and deadly medical complications is an infection on top of an existing condition. Approximately 60% of cancer deaths are due to infections. Invasive tests and blood cultures can take weeks for results. Some physicians rely on empirical treatment, which is contributing to the rise of superbugs,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards. “Using the Karius Test has the potential to both improve patient outcomes and lessen the strain on clinicians pursuing an accurate diagnosis. Karius is helping clinicians save lives, using a unique combination of genomics and AI. Congratulations on this ingenious innovation and for being the winner of our ‘Infectious Disease Testing Solution of the Year’ award.”

, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services, and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Food Science and BioAgriculture, and more. For more information visit 