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.
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.
Founder & Director
VP of Research & Development
Sr. VP of Commercialization
Research & Development Scientist
Chief Financial Officer
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.
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.
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