Dr. Kertesz co-founded Karius in 2014 to bring the novel pathogen detection technology he and colleagues developed at Stanford closer to the bedside. Based in Redwood City, California, Karius now provides a Next-Generation Sequencing based test that is able to identify over a thousand pathogens from a single blood draw. Prior to founding Karius, Dr. Kertesz was the CEO and co-founder of Moleculo, a long-reads DNA sequencing company, which was acquired by Illumina in late 2012. Read his full bio.

PMWC 2018 Michigan takes place June 6-7, 2018.

Q&A with Mickey Kertesz

Q: Tell us a little bit about Karius – what problem(s)/need(s) are you trying to address and what technology is behind it to achieve this?

A: The challenge we see is that patients are suffering needlessly from undiagnosed infections. Infectious diseases have a profound global impact, responsible for roughly 20% of all human deaths each year. This includes patients we commonly encounter with sepsis, compromised immune systems, and difficult-to-diagnose infections.

Current diagnostic methods may be invasive, limited in their ability to detect pathogens, challenging to interpret, or susceptible to contamination.

A rapid, accurate infectious disease diagnosis can enable clinicians to improve patient care and outcomes by tailoring more effective antibiotic/antifungal therapy, eliminating unnecessary procedures, and guiding antimicrobial stewardship.

Karius provides a comprehensive, CLIA-certified, CAP-accredited test capable of identifying more than 1,000 pathogens from a standard blood draw. It uses next-generation sequencing to detect cell-free pathogen DNA circulating in a patient’s bloodstream, with a typical turnaround time of one day from sample receipt.

Q: Can you discuss a couple of use cases that demonstrate Karius’ approach?

A: The Karius™ test is being used in a number of applications, including detecting pathogens in diagnostically challenging or culture-negative infections like sepsis, endocarditis, fever of unknown origin, and patients who have received antibiotic pre-treatment.

We are also able to quickly and accurately identify many deep-seated infections such as invasive fungal infections that might otherwise require invasive biopsies, and monitor immunocompromised patients who are susceptible to a broad range of pathogens, including stem-cell transplant recipients.

Clinicians across the country are using the Karius test to be able to precisely target antimicrobial therapy in some cases where blood cultures are negative, including febrile neutropenia and infections with fastidious organisms.

Q: You are developing cell-free DNA testing for infectious disease diagnostics - is there enough signal (material) to make this happen?

A: For infectious disease detection, the pathogen DNA signal in plasma is about one millionth the level of the human DNA signal. The signal for individual pathogens is often much less than that, unless the patient is very sick. This makes it hard for widely available technologies to be able to extract meaningful information.

Karius is the first team to characterize this microbial cell-free DNA signal (cfDNA) and offer a commercial cell-free test in the United States to detect pathogens.

We do this by putting great focus on the rigorous standards of our laboratory procedures. These include reducing environmental contamination, enriching the pathogen DNA signal to increase the signal:noise ratio, and controlling for known sources of bias. This combination of techniques gives us far better sensitivity and precision than standard NGS protocols, allowing us to accurately and rapidly detect and identify pathogens from the cfDNA signal.

Q: What are the advantages of cell-free DNA testing and what are some challenges that still need to be overcome to make its detection a routine in the clinic?

A: With cell-free DNA, there are three main advantages: we can rapidly detect a broad range of pathogens from infections throughout the body. Firstly, cfDNA allows us to see nearly every class of microbes with a single test. Secondly, an infection can also be picked up anywhere in the body, meaning that the patient may not need to undergo an invasive biopsy. Lastly, cfDNA closely tracks the level of infection in real-time – if a patient has an infection and it clears, the cell-free DNA signal also dissipates.

Compared to other diagnostic companies, our main differentiator is that we are a broad test, and most others are narrow panels or tests for single pathogens. While blood cultures are fairly broad and can grow a variety of microbes, they are prone to becoming sterile once the patient is put on antibiotics. Once this happens, the patient is even harder to diagnose, but our test can still detect the pathogen DNA. In these ways, the genomics approach carries many advantages to the alternative options.

The challenges to making this a routine part of clinical care include changing the current paradigm of diagnostic testing and helping clinicians trust that there can be a better way than the current standard protocols.

Q: What needs to be achieved and how should we all work together as a community to take infectious disease diagnostics into the genomics area? What are some of the major challenges we need to overcome?

A: As a precision medicine community, we can work together to raise awareness in our networks about the opportunities for improved patient outcomes as a result of genomics. We can demonstrate the benefits with clinical studies, and share our findings openly. We will need to overcome existing hospital infrastructure, work our way into standard medical training, and find early adopters within the medical system to champion this wave of precision medicine for the benefit of patients.

Q: Is there anything else you would like to share with the PMWC audience?

A: We believe that in five or six years, genomics will be the standard way to diagnose infectious diseases.

To sum up, Karius arms physicians with a single test that can deliver a potentially life-saving diagnosis, often more quickly than traditional testing methods, when time is critical. Compared head-to-head with several traditional methods, the Karius test proved faster and more sensitive; in many instances, detecting pathogens missed by standard culture-based methods.

A number of clinical trials are currently underway to gather data about the impact of Karius testing on invasive fungal infections in immunocompromised patients, fever and neutropenia, endocarditis, and other culture-negative sepsis syndromes. Karius is well positioned to become an important tool for clinicians working in infectious disease, oncology, transplantation and critical care.

We are open to collaborations with doctors and researchers across the US, and have launched a Clinical Investigator Awards program to grant $50,000 to two promising research projects in the field of Applied Infectious Disease Genomics. You can submit your application here before June 30, 2018 – http://events.kariusdx.com/CIawards.

Interview with Daniella Beller, Manager, Maccabi Research Institute Biobank

Q: What makes the Maccabi Research Institute biobank unique?

A: To explain the uniqueness of the Maccabi Biobank (named “Tipa” in Hebrew which means “drop” or “just a little”), first you must know a little about Maccabi.

Read More

Why We Need Public-Private Partnerships (PPP) To Foster Drug Discovery

Investments in pharma R&D has substantially increased over the last decades. Yet there appears to be no clear correlation to the number of newly approved drugs. This fact is accompanied by ever-increasing healthcare costs, fueled by an aging population and the parallel rise in the chronic disease burden.

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Precision Medicine: A Decade of Improving the Standard of Care

In January, PMWC will host its 2019 Silicon Valley event, the largest Precision Medicine conference in the world with over 2,500 attendees gathering at the Santa Clara Convention Center. We are humbled and honored to have reached this stage of growth and are looking forward to continuing our work with key stakeholders and decision makers across the industry to ever strengthen this forum for exchange of critical and timely topics, to move the field of precision medicine forward and to improve the Standard of Care.

Read More

Interview with David Hong from Karius

Q: What need is Karius addressing?

A: Physicians often have difficulty pinpointing the exact pathogen that is causing disease. Conventional diagnostics like blood cultures or PCR can have poor sensitivity due to pretreatment with antibiotics, the breadth of potential pathogens present, and the requirement for invasive procedures to access deep-seated infections.

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Interview with Charles Jaffe, MD, PhD from HL7

Q: What need is HL7 addressing?

A: For more than three decades, HL7 has provided the platform to enable global health data interoperability. This is more important than ever, as the cost of healthcare has increased exponentially, and the complexity of clinical evidence has grown to an almost unmanageable state.

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Interview with Eden Haverfield from Invitae

Q: What need is Invitae addressing?

A: Our mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae is uniquely positioned to answer some of life’s most serious and complex questions with the highest quality genetics and at an affordable price.

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Call by Ralph Snyderman (Duke U.) for Big Changes to Get to the Next Level of Precision Medicine

Beyond next-generation gene sequencing and developing diagnostic tools and targeted therapies, theoverall approach to clinical care has to be re-envisioned to fulfill the promise of precision medicine. Care must move from sporadic treatment of episodic disease (a reactive mode) to predicting disease and then acting to prevent and mitigate it (a proactive mode).

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Interview with William Hearl From Immunomic Therapeutics, Inc.

Q: What need is Immunomic Therapeutics, Inc. addressing?

A: Immunomic Therapeutics’ nucleic acid vaccines have the potential to utilize the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory.

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Interview with Ralph Snyderman from Duke University

Q: What are some of the critical contributions that academic institutions and medical centers are making to implement and accelerate precision medicine?

A: Over the past decade, the field of precision medicine has created technologies enabling far more personalized and effective health care delivery. Many of the most dramatic advances have come in the field of oncology but targeting care to the needs of the individual is rapidly achieving broader applications.

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Interview with Catherine Reinis Lucey from UCSF

Q: What research are you or your lab focusing on and why, and what problem(s) are you trying to solve?

A: My work involves designing, implementing and studying innovations in medical education that allow our medical schools to fulfill our social contract to improve the health of our communities and reduce the suffering of our patients.

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Interview with Gunnar Carlsson from Ayasdi

Q: What need is Ayasdi addressing?

A: Ayasdi is pioneering the application of artificial intelligence to value-based care by targeting two of the most complex problems in healthcare: population risk stratification and clinical variation management.

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Interview with Nikole Kimes from Siolta Therapeutics

Q: What need is Siolta Therapeutics addressing?

A: Chronic diseases, including inflammatory diseases such as asthma, now represent the leading cause of mortality and morbidity worldwide.

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Note from Dr. Patrick Conway, President & CEO, Blue Cross and Blue Shield NC to PMWC

VC activity is booming in healthcare, with second quarter drawing in $5.1 billion in capital. That is 22% of the total $23 billion raised by all VC-based companies in the U.S., according to latest Pricewaterhouse Coopers quarterly report.

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Interview with Atul Sharan, Co-founder and CEO, CellMax Life

Q: CellMax has developed non-invasive blood tests based on Circulating tumor cells CTC. How do you see these tests being adopted clinically?

A: Survival rates are greater than 90% for cancers that are detected at an early stage.

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Interview with Wendell Jones from Q² Solutions | EA Genomics

Q: What need is Q² Solutions | EA Genomics addressing?

A: As a leading provider of genomic services in clinical trials and discovery, Q² Solutions | EA Genomics advances science by harnessing technological expertise to drive understanding of the human genome and disease biology to detect the effects of therapies.

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University of Michigan

The Precision Medicine World Conference (PMWC), held annually in Silicon Valley, is coming back to North Carolina for its 2nd Conference back at Duke University on September 24-25, 2018.

PMWC 2018 Duke, the 15th installment of the conference, will spotlight the explosion of biomedical technologies, driving initiatives that enable the translation of precision medicine into direct improvements in health care.

 

  • Track 1 will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
    • Digital Phenotyping
    • Precision Public Health
    • Pharmacogenomics
    • The Microbiome
    • Rare Disease Diagnosis
    • Digital Health/Health and Wellness
    • Early Days of Life Sequencing
    • Diversity in Precision Medicine
    • Resilience
    • AI and Machine Learning
    • Gene Editing
    • Large Scale Bio-data Resources to Support Drug Development (PPPs)
    • Point-of Care Dx Platform
    • FDA Efforts to Accelerate PM
    • Implementation into Health Care Delivery
    • Next Gen. Workforce of PM
    • Immunotherapy
    • Robust Clinical Decision Support Tools
    • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
    • Neoantigens
    • Emerging Technologies In PM

The Precision Medicine World Conference (PMWC), held annually in Silicon Valley, is coming back to North Carolina for its 2nd Conference back at Duke University on September 24-25, 2018.

PMWC 2018 Duke, the 15th installment of the conference, will spotlight the explosion of biomedical technologies, driving initiatives that enable the translation of precision medicine into direct improvements in health care.

 

    • Track 1 will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
      • Digital Phenotyping
      • Precision Public Health
      • Pharmacogenomics
      • The Microbiome
      • Rare Disease Diagnosis
      • Digital Health/Health and Wellness
      • Early Days of Life Sequencing
      • Diversity in Precision Medicine
      • Resilience
      • AI and Machine Learning
      • Gene Editing
      • Large Scale Bio-data Resources
        to Support Drug Development (PPPs)
      • Point-of Care Dx Platform
      • FDA Efforts to Accelerate PM
      • Implementation into Health Care Delivery
      • Next Gen. Workforce of PM
      • Immunotherapy
      • Robust Clinical Decision Support Tools
      • Creating Clinical Value with Liquid Biopsy
        ctDNA, etc.
      • Neoantigens
      • Emerging Technologies In PM
  • Track 2- PMWC 2018 Duke Showcase, will enable 15-minute company presentations on latest novel technologies. Apply to present here.
big data diagnostics session

Clinical Dx Showcase

crispr showcase

Emerging Therapeutics Showcase

NGS Showcase

Genomic Profiling Showcase

AI Showcase Session Image

AI and Data Sciences Showcase

  • Luminary and Pioneer Awards, honoring individuals who contributed, and continue to contribute, to the field of Precision Medicine
  • 500+ multidisciplinary attendees, from across the entire spectrum of healthcare, representing different types of companies, technologies, and medical centers with leadership roles in precision medicine

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