, a genomic expert for biologics testing and a leader in improving pathogen identification in clinical biological samples, today announced the initiation and enrollment of the first patient in a medico-economic study testing the company’s metagenomic iDTECT™ Blood test. The IDENTIFY (NCT03364257
) trial will enroll approximately 100 adult and pediatric patients from three Assistance Publique – Hôpitaux de Paris sites. The test will be run in the Saint Louis Hospital Microbiology Department laboratory using PathoQuest’s IVD CE iDTECT Blood
IDENTIFY, a multicenter prospective study, will assess the performance of iDTECT Blood to identify the causal pathogen for bloodstream infection in patients treated for acute leukemia or receiving stem cell transplants who develop febrile neutropenia, a key driver for increased healthcare costs in these patient populations.
Results from iDTECT Blood will be compared to those from conventional testing methods, which typically includes blood cultures or PCR testing. Information on clinical and resource utilization will also be collected for key dimensions associated with the management of patients with febrile neutropenia. This includes the extent and repetition of tests and procedures used for pathogen identification, antimicrobial strategy, complications associated with antibiotics, the profile and clinical evolution of bloodstream infection episodes, and the type of hospitalization required during a 30-day period.
“Sequencing platforms are now more broadly available in academic clinical microbiology laboratories. This gives us the appropriate setting to assess the clinical performance of iDTECT Blood in conditions very close to routine practice,” stated Dr. Jerôme Le Goff, Microbiology Department, Saint Louis Hospital (Paris, France) and Microbiology Coordinator for the study. “The broad spectrum of pathogens accessible with this test should increase the rate of bacteria and virus identification in deeply immuno-compromised patients and could reduce the number of complementary procedures required when no pathogen is identified with the conventional methods.”
All patients undergoing a stem cell transplant procedure or treated with chemotherapy for an acute leukemia develop neutropenia, which increases their susceptibility to infection and reduces their ability to efficiently respond to such situations. Nearly all patients will consequently present with at least one episode of febrile neutropenia. The identification of a responsible pathogen remains a challenge in this patient population and conventional testing techniques result in the identification of a pathogen in only about 20% to 30% of patients. The rapid administration of an appropriate antimicrobial regimen is an essential step in infection control for these seriously ill patients for whom bloodstream infection is a life-threatening condition, and in the absence of microbiological information, broad spectrum antibiotics are systematically used instead of targeted antibiotics. There is therefore a need for improved microbiology diagnostic methods that have the potential to enable a more personalized antimicrobial treatment strategy.
“In immunocompromised patients presenting with a suspicion of infection, the identification of the responsible pathogen is often not possible with current methods. This has an impact on the selection of the most appropriate antimicrobial strategy,” said Professor Gérard Socié, Head of the Stem Cell Transplantation Department at the Saint Louis Hospital (Paris, France) and Coordinating Investigator for the study. “This trial with iDTECT Blood will give us precise information on how this new test could influence anti-infective strategy and ultimately patient management.”
“The initiation of the IDENTIFY study underscores our commitment to bringing new and innovative tests to microbiologists and clinicians,” said Jean François Brepson, President and CEO of PathoQuest. “By improving the identification of a causal pathogen, iDTECT will enable an optimized and individualized care for immunocompromised patients with suspected infections. This study is also an essential step for the path to obtain full reimbursement for the test.”
About iDTECT™ Blood
PathoQuest has developed iDTECT Blood, the first and only clinical CE IVD metagenomic test for infectious disease diagnosis. Using a single blood sample, the test provides clinicians and microbiologists with a culture-free method for detecting more than 1,200 bacterial or viral pathogens in a turn-around time of 48 hours. The test is run in expert microbiology laboratories, accredited for the method, which allows to minimize the time between sampling and laboratory processing, and to streamline the interactions and decision process between microbiologists and the treating clinical team.
PathoQuest, a spin out of Institut Pasteur, is a life sciences company offering a game changing metagenomics approach to improving pathogen detection in biological samples. PathoQuest’s technology combines a Next-Generation Sequencing (NGS) platform and a proprietary sample preparation process which is applicable to several types of samples with a proprietary pathogen genome sequence database and automated analysis pipeline. The company’s solution provides microbiologists and clinicians with a comprehensive analysis covering all known clinically relevant human pathogens.
Based on the company’s technological platform, PathoQuest also offers biopharmaceutical companies a disruptive approach to secure production of biologics like vaccines and recombinant proteins. PathoQuest’s Biological Genomic Services are currently being utilized by several major biopharma companies. A strategic partnership has been recently signed in that field with Charles River Laboratories.
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