Clinical Diagnostics

iDTECT® Dx 

The iDTECT® Dx Blood test is a new approach to the identification of pathogens. The test, which is the first IVD CE Marked metagenomic test using next generation sequencing (NGS) to identification microorganisms responsible for infections in patients, was originally developed at the renowned Institut Pasteur, by worldwide experts in the domain of infectious diseases.

  • The iDTECT® Dx test utilizes advanced metagenomic methods to identify bacteria and viruses in blood samples from patients.
  • Using proprietary methods developed by PathoQuest, blood samples are prepared and then analyzed using the latest next-generation sequencing technology to identify genomic sequences of pathogens which may be present in a patient’s blood.
  • Genomic sequences identified are then compared to a comprehensive and curated database PathoQuest has developed which contains genomics sequences from over 1,200 bacteria and viruses. The company works with experts in clinical microbiology and infectious diseases to regularly update the database and determine clinicallyrelevant pathogens which should be included in this database.
  • A report identifying any pathogens present in the blood sample is provided to microbiologists and physicians to assist them to determine the most appropriate treatment approach.

The iDTECT® Dx Test is performed in 3 steps:

Patient's blood sample

PathoQuest’s patented sample preparation

Sequencing

Automated workflow

Matches sequencing results with a proprietary database

Benefits

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Innovative

Identifying pathogens – the problem associated with the current clinical approach

The iDTECT® Dx Blood test differs from conventional testing methodologies because it does not require a lab to “grow” the microorganisms, and does not require microbiologists and clinicians to preselect which bacteria or viruses they want to test for.

The iDTECT® Dx test can identify DNA and RNA sequences from bacteria and viruses present in only small quantities in blood samples and also utilizes a non-targeted approach to the identification of pathogens.

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Clinical benefits

What are the potential clinical benefits of the iDTECT Dx Blood Test?

  • The iDTECT® Blood Test is designed to improve the ability and frequency to identify pathogens responsible for infections, especially in immunocompromised patients, potentially enabling clinicians the ability to better identify and utilize targeted antibiotic therapies and avoid overutilization and extended use of broad-spectrum antibiotics.
  • The test is thus also intended to help reduce the use of inappropriate and ineffective broad-spectrum antibiotic therapies in order to potentially help improve antibiotic stewardship and reduce risks of antibiotic resistance.
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Database & Software Suite

PathoQuest has developed proprietary tools to optimize the analysis steps and allow for rapid and accurate identification of pathogens present in blood samples. The entire pipeline is packaged into a state-of-the-art cloud-based software solution that is scalable, robust, and easy to manage.

  • A fully validated and expertly curated proprietary database derived from publicly available collections of genomic information on bacteria and viruses.
  • A fully automated process that can analyze large amounts of sequencing data and export results report in less than 30 minutes.

The above contributes to suboptimal patient outcomes, prolonged hospital staystreatment-related complications, and finally an increased cost of care. Ineffective identification of pathogens, the inappropriate use of antibiotics, and the progressive development of antimicrobial resistance also put patients at risk following commonly performed elective surgical procedures such as prosthetic orthopedic surgery and when receiving cancer treatment.

Quality and Regulatory

To comply with In Vitro Diagnostic Device Regulation (98/79 CE) and to continually improve the effectiveness of the Quality Management System (QMS), the company implements a Quality Management Program following several ISO standards recognized and linked to international regulations  ISO 13485, US cGMP 21 CFR part 820 and ISO 9001.

iDTECT® Blood is the first and only CE-IVD metagenomic test for blood stream infections.

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