Ephraim L. Tsalik, MD, MHS, PhD, FIDSA

Danaher Diagnostics, Chief Scientific Officer for ID Diagnostics
Duke University Medical Center, Adjunct Professor
Durham VA Health Care System, Emergency Department Service Staff
ARLG Diagnostics Subcommittee Member
ARLG Innovations Working Group Member

About my role in ARLG

My journey with the ARLG began in 2014 while a junior faculty member at Duke. I had two primary roles in ARLG: 1) as a contributor and 2) and as recipient. As a recipient, I have been the principal investigator for the Rapid Diagnostics in Categorizing Acute Lung Infections (RADICAL) series of studies.

The RADICAL studies were founded on the ‘radical’ idea that we could measure a patient’s immune response to determine whether a bacterial or viral infection was present even when the pathogen itself could not be found. The RADICAL studies began with pre-clinical work that validated host gene expression biomarkers in large patient cohorts. RADICAL-2 supported the translation of these biomarkers to point-of-need diagnostic test platforms and validated them in larger and more heterogeneous populations. MASTER-RADICAL extended the test development in collaboration with Biomeme, a Philadelphia-based molecular diagnostic company. RADICAL-3 is next and will evaluate the clinical utility of this innovative test to improve antibiotic use.

As a contributor to ARLG, I have been the associate director of the ARLG Laboratory Center, where I worked with other ARLG leaders. The goal of the Lab Center is to interface with industry, investigators, and other academic partners to leverage ARLG resources that include:

• Intellectual access to international thought leaders,
• Microbiological access to clinically well-characterized Gram-positive and Gram-negative bacteria through the Virtual Biorepository (VB) Catalogue, and
• Financial support of studies that advance or evaluate diagnostics for antibacterial
  resistance.

My work in diagnostics led to an interest in the MASTERMIND (MASTER protocol for evaluating Multiple INfection Diagnostics) concept that is based on the following premise: One single participant can provide information and samples for the simultaneous evaluation of multiple diagnostics. This concept, similar to platform studies used in oncology, represents the first standardized approach in the development of
diagnostics.

The ARLG’s first successful MASTERMIND study was the MASTER-GC study which evaluated three different platforms for the detection of extragenital gonorrhea and chlamydia infections. One of our biggest achievements of this study was the collaboration
of three companies, who are typically competitors in this space, to work together towards one common goal: Use the study results to support their own FDA application for these new indications.

The next MASTERMIND study will focus on blood-stream infections. We are interested in evaluating diagnostics that detect pathogens directly from a blood sample, without the need for culture. There have been some truly exciting innovations in this area and we are excited to evaluate those in hopes of accelerating their development and clinical use.

Impact of ARLG Research Funding to my Career

ARLG’s support is perhaps most evident in the results and accomplishments of successful science, whether in the RADICAL projects, MASTERMIND studies, or countless interactions with academic and industry collaborators. What some may not be aware of is how ARLG’s support has allowed me to grow and develop.

My ARLG engagements have allowed me to take part in incredible science and work with incredible people. They served as inspiration for what is possible and allowed me to develop my own expertise in the diagnostics space. I successfully moved through the academic ranks to become a tenured associate professor at Duke. Building on that success, I recently accepted a position as the Chief Scientific Officer for infectious diseases at Danaher Diagnostics. In that role, I will identify what investments we can make now that will produce the next generation of infectious disease diagnostics. This will include host response-based diagnostics, which enables me to continue working on the science I have been developing since 2008. There is no doubt I would not have achieved this milestone without the support and opportunities provided by the ARLG.

Although I will necessarily have to step away from some of my ARLG responsibilities, I am excited to continue working on the MASTERMIND-BSI project and to join the Diagnostics Subcommittee and the Innovations Working Group. Indeed, my ability to remain a part of the ARLG while taking a position within industry speaks to ARLG’s desire to learn from all members of the ID community as it works to address the antibacterial resistance problem.

Benefits of ARLG
Beyond the personal benefits already described, I have also appreciated ARLG’s visionary and innovative approach to combat antimicrobial resistance. They are not constrained to following the well-worn path and will gladly take the road less traveled if it improves processes or delivers better solutions. This is evident in ARLG’s science and projects. More importantly, this approach will benefit people all over the world. As a result, ARLG’s impact will be felt far, wide, and for a long time to come.