Embleema and George Washington University-led Consortium Wins FDA Contract to Advance the Fight Against Infectious Disease Outbreaks

Embleema, a New Jersey-based healthcare technology company, has partnered with investigators at The George Washington University (GW) and Temple University (TU) to advance the Food and Drug Administrations (FDA) Database for Reference Grade Microbial Sequences (FDA-ARGOS).

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Thursday, October 28, 2021
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University, Data Management, Education, Technology, FDA, Health, General Health, Research, Infectious Diseases, Software, Science, George Washington University, Research, Molecular medicine, Ecosystem, Database, Vaccine, DRS, Genomics, Crandall, FDA, Temple University, Food, Pandemic, Severe acute respiratory syndrome coronavirus 2, Simonyan, CEO, ARGOS, GW, Microbiology, Biochemistry, Therapy, Weatherall Institute of Molecular Medicine, Pharmaceutical industry, Medical device
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NEW JERSEY, United States
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Summary
Key Points: 
  • Embleema, a New Jersey-based healthcare technology company, has partnered with investigators at The George Washington University (GW) and Temple University (TU) to advance the Food and Drug Administrations (FDA) Database for Reference Grade Microbial Sequences (FDA-ARGOS).
  • Embleema was awarded a contract worth $1,992,223 by the FDA for the development of quality matrix tools for FDA-ARGOS containing regulatory grade reference genomes for diagnostic use and regulatory science.
  • It is also clear that regulators need a sustainable, evolving ARGOS ecosystem that can be continuously enriched with novel information on existing and emerging pathogens.
  • Embleemas standard technology platform accelerates personalized medicine by expediting evidence generation and regulatory reviews of new treatments.


Embleema, a New Jersey-based healthcare technology company, has partnered with investigators at The George Washington University (GW) and Temple University (TU) to advance the Food and Drug Administration’s (FDA) Database for Reference Grade Microbial Sequences (FDA-ARGOS). Embleema was awarded a contract worth $1,992,223 by the FDA for the development of quality matrix tools for FDA-ARGOS containing regulatory grade reference genomes for diagnostic use and regulatory science.

Considering the on-going SARS-CoV-2 pandemic, it is more critical than ever to have accessible, interoperable, reliable, and curated information to evaluate the spread of viral and bacterial species, respiratory, food and environmental pathogens in the context of current and future pandemics, seasonal epidemies, and potential biological threats. The deluge of unverified or heterogeneous genomic information flowing from thousands of sources around the world can be overwhelming for research and regulatory scientists who are trying to develop and evaluate diagnostic devices or vaccines. There is a need to have well characterized and reliably sourced isolates connected with systematized, quality controlled, well annotated regulatory grade sequences that are representative and clinically relevant. It is also clear that regulators need a sustainable, evolving ARGOS ecosystem that can be continuously enriched with novel information on existing and emerging pathogens.

Using the Embleema HIVE technology platform, the Consortium’s world-class team in the field of microbiology and bioinformatics with vast expertise in research and regulatory sciences will enhance ARGOS, a standard, regulatory-grade knowledge base of genomic sequences enriched with quality-control, variation, structural and functional annotations accessible for the wider scientific community.

“We are delighted to partner with GW and Temple University to help the FDA enable academic researchers, life sciences, health agencies and regulators to rapidly and easily access critical information for developing new vaccines, therapies and diagnostics faster against pathogens such as SARS-CoV-2,” said Robert Chu, CEO of Embleema.

“I am excited to work with Drs. Simonyan, Crandall and Pond who are leading authorities in bioinformatics and genomics on this foundational project. Our goal is to provide high-quality reference genomic data and comprehensive annotation for use in regulatory science research and the development of diagnostics, therapeutics, and vaccines,” said Dr. Raja Mazumder, Professor of Biochemistry and Molecular Medicine and Co-Director of The McCormick Genomic Proteomic Center at The George Washington University.

About Embleema

Embleema’s standard technology platform accelerates personalized medicine by expediting evidence generation and regulatory reviews of new treatments. From establishing trusted real-world and clinical data networks to making complex data sets regulatory grade, Embleema helps its clients from life sciences, academia, regulatory agencies, and patient advocacy build a healthier world. For more information, please visit www.embleema.com.

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