Developing metagenomic-based Infectious Disease tests for use in clinical settings is complex, the development process can be extremely costly and time consuming. A CLIA lab can spend years and millions of dollars before they even launch a test. And, following launch constant investment may be required to continuously improve technology and databases.

The Explify Platform provides a turn-key solution that seamlessly integrates into clinical laboratory workflows, enabling laboratories to develop Infectious Disease tests quickly while minimizing time and costs.

Explify analytics and databases utilize deep machine learning for continuous improvement so laboratories using the Explify Platform always have the most up-to-date and advanced technology.

Case Study: Implementing Explify for Respiratory Pathogen Testing at a Reference Laboratory

Fleury is a Brazilian reference laboratory that provides medical laboratory testing services carrying out 3,500 tests in 37 areas throughout Brazil.

Since conventional diagnostic test results frequently come back negative for patients hospitalized with pneumonia, Fleury was looking to build a more comprehensive diagnostic solution using NGS-based metagenomics to help their clients identify pathogens often missed by PCR and culture.

Contact us to learn how the Explify Platform can enable your lab’s test development

Infectious Disease and Microbiome research requires the comprehensive and accurate identification and profiling of microorganisms. IDbyDNA offers Explify Research to collaborating institutions to identify microorganisms in any sample type and provide clinical information to associate those organisms to health and disease phenotypes.

Case Study: University of Groningen, The Netherlands

The University of Groningen is a global research university, located in Groningen, The Netherlands. Faculty in the Personalized Microbiology Research Group were interested in studying the use of metagenomics for clinical diagnosis. They needed a testing platform to enable their work. After making an assessment of the metagenomic tools available they chose to evaluate the Explify Platform.

Empowering Biopharma Innovation

  • Bioproduction Safety
  • Companion Diagnostics
  • Clinical Trials

Bioproduction safety

The safety of vaccines and other biological products is essential for industry and regulatory agencies. Reagents and materials used in the manufacturing process, especially those derived from animals, pose risks of introducing adventitious agents (viral, bacterial, or fungal contaminants) into the manufacturing process.

To ensure product safety, extensive testing is performed using various in vitro and in vivo tests. While generally effective, conventional tests have inherent limitations that may lead to adventitious agents being missed, highlighting the need for new virus detection technologies.

Explify offers a new approach for adventitious agent testing:

  • Identifies any known virus or emerging virus using comprehensive and curated databases of all known viruses
  • Detects viruses, bacteria, and fungi
  • Identifies unknown microorganisms without requiring prior knowledge of potential targets

Companion diagnostics

Novel antimicrobial agents often target specific pathogens. To determine which patients will most benefit from novel therapeutics, clinicians need to accurately and specifically identify those targeted pathogens.

Companion diagnostics developed on the Explify Platform enable the accurate identification of specific pathogens in patient samples that can potentially guide more efficient treatment decisions.

Clinical trials

Conducting clinical trials for novel antimicrobial drugs requires the rapid and accurate identification of target patients.

The Explify Platform enables pharmaceutical companies to quickly identify the appropriate patients to enroll and the diagnostic tools to manage clinical trials.

Case Study: Developing Explify Tests For Clinical Trials and Companion Diagnostics For Novel Antimicrobial Therapies to Treat Drug Resistant Bacterial Infections

Locus Biosciences is an emerging biotechnology company focused on the discovery and development of a next generation CRISPR-Cas platform for precision antimicrobials.

Locus needed to develop a diagnostic test for patient selection and evaluation for their clinical trials of LBx-PA01 a CRISPR-based precision antimicrobial product that targets and precisely eliminates Psedomonas aeruginosa, including multidrug-resistant strains identified as a “Serious Threat” by the CDC.

Locus partnered with IDbyDNA to develop an Explify-based companion diagnostic test that will allow Locus to quickly identify patients who are likely to benefit from treatment with LBx-PA01, increasing the probability of successful clinical trial results. Once LBx-PA01 reaches the market, the test will ensure that the medication will be given to patients with the greatest opportunity to benefit from it, improving patient outcomes and reducing the overall cost of treatment.

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