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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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Bay Area-based company can help test for monkeypox through blood testing

Rapid Diagnostic Methods and Technologies in the Management Of Infectious Diseases

How Karius aims to transform the diagnosis of infections with a non-invasive liquid biopsy

Metagenomic Sequencing Moves to the Clinic

How This Multi-Million Dollar Startup Could Make It Easier to Identify the Next Epidemic

The Top 25 Biotech CEOs of 2021

 – 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

__________________________________________

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

, 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 

Karius Test Named “Infectious Disease Testing Solution of the Year” at Inaugural 2021 BioTech Breakthrough Awards

– Karius, the world leader in liquid biopsy for infectious diseases, has received approval from the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) for its Karius Test for pathogen detection. The Karius Test is commercially available from a single CLIA-certified and CAP-accredited laboratory in Redwood City, CA, as a Laboratory Developed Test (LDT). The decision by CLEP is a first-in-class approval of a clinical metagenomics test for the detection of infectious diseases, and will expand patient access to critical testing in New York.

The Karius Test is primarily used to detect specific causative pathogens in immunocompromised patients and other specific clinical syndromes. Immunocompromised patients are particularly vulnerable to infection; for example, 60% of deaths among cancer patients are due to infection (Elfaituri M.K.et al. J. Clin. Oncol., 2019).

The NYS permit covers Karius Testing for all five pathogen categories, namely bacteriology, mycobacteriology, mycology, parasitology, virology, and is an important validation granted via one of the most stringent laboratory certification programs in the country. It reaffirms the quality, accuracy, and reliability of Karius’ non-invasive single-draw blood test that uses next-generation sequencing of microbial cell-free DNA to rapidly detect over 1,000 bacteria, DNA viruses, fungi, and parasites causing both localized and bloodstream infections.

“We applaud this decision from the NY State Department of Health, as this first-in-class approval will accelerate access for patients in New York to our metagenomic infectious disease diagnostic test,” said Alec Ford, CEO of Karius. “Doctors and hospitals all across the country are aware of the rigorous review process CLEP adheres to when evaluating laboratory tests, and we are proud of meeting these high quality standards. With better access to the Karius Test, we’re excited for the opportunity to help get fast, accurate diagnoses into the hands of clinicians and reach more patients in New York.”

For more information, please visit kariusdx.com and follow @KariusInc on Twitter.

Karius receives New York State permit for its liquid biopsy test to detect infectious diseases

Leading authority on infectious disease, Dr. Bradley Perkins, to accelerate clinical evidence of the Karius TestTM, a liquid biopsy for infectious disease

, the world leader in liquid biopsy for infectious diseases, announced Bradley Perkins, MD, as the company’s new Chief Medical Officer (CMO). Dr. Perkins most recently served as the co-founder and Chief Medical Officer at The Commons Project Foundation, helping establish it as the premier non-profit organization building global digital services and platforms for the common good.

Dr. Perkins’s extensive leadership background in both the public and private sectors began during his time at the Centers for Disease Control and Prevention (CDC), where he led the investigation into the anthrax attacks in the U.S. – at that time the largest inquiry in CDC history. He later served as the CDC’s Chief Strategy and Innovation Officer, before taking executive roles at Vanguard Health Systems and Human Longevity, Inc.

“Winning the battle against infectious diseases is an urgent global health priority,” said Dr. Perkins. “By giving doctors a powerful new diagnostic tool, Karius has established itself as one of the most innovative companies helping to improve outcomes for patients suffering from infectious diseases. I’m excited about the potential for it to scale even further, allowing us to impact lives on a global level.”

“Brad’s experience dealing with major health issues at the highest level will be invaluable to Karius as we enter our next growth phase,” said Karius CEO Alec Ford. “I am pleased to welcome Brad to a team that is focused on our vision of a world where infectious disease is no longer a major threat to human health.”

Dr. Perkins’ appointment comes on the heels of a year of tremendous growth for Karius. A $165 million Series B funding round, led by SoftBank Group’s Vision Fund 2, was the largest AI healthcare investment of Q1 2020, according to CB Insights. Karius was also recognized by Forbes as one of America’s top 50 most promising artificial intelligence companies.

The company also saw increasing adoption of its Karius Test, a liquid biopsy that can non-invasively and rapidly detect more than 1,000 pathogens from a single blood sample. The Karius Test helps clinicians avoid invasive, low-yield, and sequential diagnostic tests that can delay treatment for the most vulnerable hospitalized patients. The Karius Test is now being used in over 100 hospitals and healthcare systems across the United States.