Ephraim Tsalik, MD, PhD
Duke University Medical Center
Associate Director of Diagnostics and MASTERMIND (MASTER protocol for evaluating Multiple INfection
Diagnostics)
About my role in ARLG
I have two primary roles in ARLG: 1) as a contributor and 2) and as recipient. As a recipient, I am the principal investigator for the Rapid Diagnostics in Categorizing Acute Lung Infections (RADICAL) study. ARLG has been a supporter of RADICAL from the
project’s initial phase. We are currently in phase two of three expected phases. RADICAL-I focused on the development of a platform capable of measuring gene expression in a clinically meaningful way. RADICAL-II is testing the platform in a heterogeneous population
with considerations for age, ethnicity, co-morbidities, and geographic location. We envision RADICAL-III as a clinical-utility study where real-time results will be used to determine the clinical value of the test in discriminating bacterial and viral infections. RADICAL results will
be presented at IDWeek 2018tm and ARLG created this summary of study results geared towards the public reader.
As a contributor to ARLG, I am the associate director of the ARLG Laboratory Center, where I work with other ARLG leaders. Our goal 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.
An example of the MASTERMIND protocol in action is the MASTER-GC study. MASTERGC 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. Extragenital infections are infrequent enough that no one company would be motivated to fund an individual research and diagnostic program; however, the companies agreed to participate knowing that ARLG was providing funding, resources, and support. In the end, the companies were happy with their participation and the study has the potential to be a
win-win situation for all parties involved.
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.
Impact of ARLG Research Funding to my Career
My career has always focused on the type of questions that we are investigating in RADICAL and MASTERMIND. ARLG’s support has been instrumental for the development and advancement of these studies by providing financial security that allows me to focus on the work and resources to hire and support research staff. In addition, I have received recognition in the institutional and scientific communities for this new and evolving approach to diagnosing illness that has the potential to answer larger questions in science and medicine.
Benefits of ARLG
Personally, what I have appreciated most from ARLG is their visionary and innovative approach to combat antimicrobial resistance. When I started out in my career researching new diagnostic approaches for host-gene expression, I often encountered skepticism and received many negative responses from conventional funding sources. However, ARLG recognizes that we cannot continue with the same approach and expect a different solution. I really want to express my gratitude to ARLG for their willingness to take a risk on an outlandish idea that has turned into an exciting and a promising RADICAL change to clinical practice.