Click the dots below to navigate Pearl Diagnostic’s history as a company and learn more about the development of our technology over the last two decades.
Built to Transform Diagnostics
About Us
Pearl Diagnostics is rooted in decades of experience in patient care and diagnostic device development at top institutions, allowing us to bring urgently needed clinical tools to health care providers.
Our technology emerged from decades of translational research by our founders, advisors and collaborators, enabling us to bring urgently needed clinical toolsets to health care providers.
Our Leadership
The Pearl Diagnostics team has expertise at every step of the diagnostics value chain, from early R&D to commercialization activities that result in new clinical diagnostic standards.
PearlDx Team
Dr. Kieren Marr is Founder and Vice President of Clinical Development of Pearl Diagnostics and a Professor of Medicine, Oncology and Business at Johns Hopkins. An international thought leader on fungal infections and immunosuppressed hosts, she has performed research on preventing infections for over 25 years, with discoveries in both diagnostics and therapeutics. In 2015, Thomson Reuters named Dr. Marr as “One of the World’s Most Influential Scientific Minds”, ranking in top 1% of cited researchers worldwide.
Irina has 25 years of leadership experience in R&D product development, manufacturing, Operations, and Quality in the In Vitro Diagnostic industry. Her accomplished, outcome-driven leadership has a proven success rate, including bringing multiple IVD tests from concept to market. With an emphasis on immunoassay development, process development, manufacturing, and commercialization, Irina is well-versed in all aspects of IVD product development, Quality Management systems, and Regulatory submissions. She has coordinated and managed product development from research to production, regulatory submissions, and market. She also has experience in Point of Care concepts and product development, creating and motivating successful project teams, and accomplished in budget and human resources management. Lastly, Irina's leadership has demonstrated a unique ability to learn and adapt to new cultures while driving change and continuous improvement in every organization she's in.
Mr. DeWayne Davenport is the Chief Executive Officer of Pearl Diagnostics and has 20 years of commercial leadership across Molecular Diagnostics, NGS, Biotechnology, and In-Vitro Diagnostics. He has led the commercialization of several small to midsized company with responsibility for commercial strategies to significantly grow organization’s revenue and profit. Notably, he has led US and European commercial launch of more several laboratory and Point-of-Care diagnostics.
Dana Neitzey plans and maintains lab operations and experiments at Pearl Diagnostics. Dana has worked in industry planning and conducting molecular research for more than a decade, following work at Johns Hopkins and the NIH. Dana’s experience ranges from cancer cells to bacteria, fungi and viruses—designing assay protocols and SOPs as well as actively leading experiments in the lab. Dana’s research has contributed to multiple publications in fields such as vaccines, metabolic engineering, and cancer research.
Patricia has 20 years of experience in researching infectious diseases and 3.5 years of experience in clinical and environmental laboratories, quality assurance and regulation, and immunoassay development. Patricia has a PhD In Infectious Diseases (University College Dublin, Ireland), MS in Medical Parasitology (Universidade Nova de Lisboa, Portugal), and Post-Doctoral in Microbial Pathogenesis (University of Maryland Baltimore). During her Post-Doctoral work, Patricia developed ELISA assays for the detection of antibodies in Chlamydia sp.
For over 25 years, Robin has facilitated organizational success for numerous businesses in various industries. As a Certified Public Accountant and I/O Psychologist, Robin’s multi-faceted tool set proves to be an asset to companies trying to realize their full potential because she can address the fiscal and functional aspects, as well as the softer organizational factors of enterprise achievement. Her skills include financial reporting and internal controls management, operational and process systems development, federal and state tax compliance, and nurturing the invaluable human determinants of organizational success.
Executive Board
Dr. Kieren Marr is the Director of Pearl Diagnostics and a Professor of Medicine, Oncology and Business at Johns Hopkins. An international thought leader on fungal infections and immunosuppressed hosts, she has performed research on preventing infections for over 25 years, with discoveries in both diagnostics and therapeutics. In 2015, Thomson Reuters named Dr. Marr as “One of the World’s Most Influential Scientific Minds”, ranking in top 1% of cited researchers worldwide.
Dr. Bradley Spellberg, Director, is a Professor of Clinical Medicine, Associate Dean for Clinical Affairs and Chief Medical Officer at LA County and University of Southern California. He is an international thought leader on antimicrobials and infections and as co-founder of 3 companies, has helped to translate three molecules currently in clinical trials.
John H. Cammack is Managing Partner of Kingcedar Holdings, an investment holding company specializing in enterprises advancing medical technologies, SaaS business services and behavioral health. He is also a Partner in the Bridge Builders Collaborative, a national coalition of private investors dedicated to improving behavioral health and mental wellbeing. From 2015-2019, Mr. Cammack served as a Mentor-in-Residence at John Hopkins University, where he advised faculty on commercialization strategies. From 1991 to 2009, Mr. Cammack was a senior executive at T. Rowe Price where he served as Division Head and member of the firm’s Operating Steering Committee, Institutional Marketing Steering Committee, Compliance Oversight Committee and the T. Rowe Price Investment Services Board. Past board assignments include SignalVine, Calvert Education and FactoryFour. Volunteer board assignments include the Mutual Fund Education Alliance, the Foundation for Financial Planning, CFP Board of Standards, Phi Beta Kappa Investment Committee, Cure Violence, Creative Alliance, Venture for America (Baltimore) and the Maryland Philanthropic Network. In addition, John is an emeritus member of the Alpha Group, a study group of Wealth Management CEOs and industry thought leaders. Mr. Cammack is a Phi Beta Kappa graduate of Denison University with a BA in History and received his MBA from Columbia University.
Scientific Advisory Board
Dr. Maertens is currently a professor of Haematology at the University Hospitals Leuven, Campus Gasthuisberg Leuven, Belgium. His major professional interest is fungal and viral infections in patients with haematological disorders, development of new management approaches to invasive aspergillosis, non-invasive diagnosis of opportunistic respiratory infections, and haplo-identical allogeneic stem cell transplantation. Dr Maertens has published over 400 articles and book chapters on antifungal management and diagnosis in several prestigious journals. He is a co-editor of the book “Diagnosis of Fungal Infections” and has made tremendous contributions in development of diagnostics and prevention strategies. He is the past chair of the EORTC-Infectious Diseases group and the current chair of the European Conference on Infections in Leukaemia (ECIL).
Dr. Sheppard is Professor in the Departments of Medicine, Microbiology & Immunology at McGill University in Montreal, Canada. He practices Infectious Diseases and Medical Mycology at the McGill University Health Centre and currently serves as the Vice President of the Infectious Diseases and Vaccination Programs Branch at the Public Health Agency of Canada. His primary clinical area of interest is human fungal disease, particularly invasive aspergillosis in the immunocompromised host. His group has made important discoveries pertaining to Aspergillus glycobiology, pathogenesis, and has developed immunologic tools for use in diagnostics and therapeutics.
Dr. Zhang is an Associate Professor of Pathology at the Johns Hopkins University School of Medicine and the Medical Director of Medical Mycology Laboratory at the Johns Hopkins Hospital.
Dr. Zhang's research focuses on developing rapid and nonculture-based tools for fungal diagnostics. These include identifying fungal pathogens from FFPE tissue blocks, fungal antigen assays, host-driven response assays, multiplex PCR and next-generation sequencing to rapidly identify fungal pathogens directly from clinical samples. He is also interested in studying identification and characterization of new emerging fungal pathogens, the role of fungal pathogens in cystic fibrosis patients, and antifungal drug resistance.
Dr. Zhang is an Executive Editor of Medical Mycology and an Editorial Board Member of the Clinical Microbiology Reviews. He is a Section Editor (Mycology) for the Manual of Clinical Microbiology (13th Edition). He serves as an advisor to the Clinical and Laboratory Standards Institute (CLSI) Antifungal Susceptibility Testing subcommittee and a member of the College of American Pathologist (CAP) Microbiology Committee. He is also a co-founding chair of recently created Fungal Diagnostics Laboratory Consortium (FDLC) in the USA/Canada.
Dr. Zhang's research focuses on developing rapid and nonculture-based tools for fungal diagnostics. These include identifying fungal pathogens from FFPE tissue blocks, fungal antigen assays, host-driven response assays, multiplex PCR and next-generation sequencing to rapidly identify fungal pathogens directly from clinical samples. He is also interested in studying identification and characterization of new emerging fungal pathogens, the role of fungal pathogens in cystic fibrosis patients, and antifungal drug resistance.
Dr. Zhang is an Executive Editor of Medical Mycology and an Editorial Board Member of the Clinical Microbiology Reviews. He is a Section Editor (Mycology) for the Manual of Clinical Microbiology (13th Edition). He serves as an advisor to the Clinical and Laboratory Standards Institute (CLSI) Antifungal Susceptibility Testing subcommittee and a member of the College of American Pathologist (CAP) Microbiology Committee. He is also a co-founding chair of recently created Fungal Diagnostics Laboratory Consortium (FDLC) in the USA/Canada.
PearlDx Timeline
2004
First in vitro diagnostic in serum is cleared by FDA
2009
Antibody Identification and Assay Development
2012
More Knowledge on the Nature of Urinary Antigens
2014
Dr. Marr and MaryAnn Shallcross Found MycoMed Technologies
2017
MycoMed partners with AsTeC
2018
IA Urine Antigen Detection Using a Lateral Flow Test
US Patents Issued
2019
MycoMed Discovers that Antigens are Displayed in and on Microbial Extracellular Vesicles
2020
Cystic Fibrosis Foundation Awards Grant
2022
MycoMed Becomes Pearl Diagnostics
CE Mark Issued for MycoMEIA Aspergillus Assay
2023
MycoMEIA Sales in Europe
The first in vitro diagnostic in serum as an aid to diagnose invasive aspergillosis is cleared by FDA.
Dr. Marta Feldmesser, at the Albert Einstein College of Medicine, develops monoclonal antibodies against the fungus Aspergillus fumigatus, with the goal of studying lung infections; surprisingly, she finds that these antibodies go into the bladder early after lung infection. Dr. Kieren Marr, working at the Johns Hopkins Medical Center, initiates clinical research protocols to collect urine samples from people hospitalized with invasive aspergillosis (IA), and uses these samples to better understand microbial antigens in urine.
Further characterization shows that the unusual antibody, mAb476, detects small molecular weight antigens in urine from people with pulmonary aspergillosis, as confirmed in animal models. This work is published for the first time in PLOS One. The team files a patent focused on the key diagnostic components of identified novel antibodies and methods of using those antibodies in assay kits to bind to Aspergillus antigens.
MycoMed Technologies, LLC is founded as a Johns Hopkins spinout company by Dr. Marr and MaryAnn Shallcross (formerly of Abbott Laboratories) to commercialize Dr. Marr’s research, focusing on the development of commercially available tests to diagnose fungal infections. The team obtains grant support from the National Science Foundation (NSF) and the National Institute of Health (NIH).
The NIH-supported Aspergillus Technology Consortium (AsTeC), led by Dr. John Wingard, partners with MycoMed to provide access to more patient urine samples that further validate the company’s diagnostic tests.
Clinical Infectious Diseases publishes the article “Urine Antigen Detection as an Aid to Diagnose Invasive Aspergillosis,” marking the major academic journal debut of this diagnostic approach.
USPTO issues patents covering antibodies, methods of using antibodies and kits binding molecules to detect galactofuranose (galf) and methods to process urine to disable inhibitors in urine.
The team submits patent coverage on how to detect microbial EVs in urine and presents data at the European Conference on Clinical Microbiology and Infectious Diseases (ECCMID).
Encouraged by the non-invasive assays in development by MycoMed and collaborators, the Cystic Fibrosis Foundation awards a grant to the team at JHU and MycoMed to deepen research into the detection of Pulmonary Aspergillosis in CF patients.
Along with its seed investment round, MycoMed Technologies, LLC becomes Pearl Diagnostics, Inc., recognizing the company’s broadened R&D focus beyond EV detection of fungal infections to other pathogens, including bacteria. Pearl Diagnostics also refers to the diagnostic “pearls” that give clinicians pivotal insight into what is causing illness.
Pearl Diagnostic receives the European CE mark designation for the MycoMEIA™ Aspergillus Assay, allowing for commercial sales in Europe.
The Pearl Diagnostic leadership team adds Irina Baburina, Ph.D. as Vice President of Research & Development, and DeWayne Davenport, MBA, as Senior Vice President of Commercialization in preparation of MycoMEIA sales beginning in Europe under CE mark later in 2023.
