PathoQuest Achieves CE Mark for the iDTECT™ Blood Test
News Oct 28, 2016
PathoQuest has announced CE marking for iDTECT™ Blood, the company’s new clinical test offering a game-changing NGS-based metagenomics approach that improves the breadth of pathogen detection. Compared to the currently available solutions, iDTECT Blood, a proprietary sample-to-report test, provides clinicians a significantly improved method for detecting bacteria and viruses in blood samples from patients with suspected infections, especially immunocompromised patients.
“With this CE marking, PathoQuest will execute its global strategy and enter in early access programmes in selected countries.” stated Helene Peyro-Saint-Paul, M.D., PathoQuest’s Chief Medical Officer. “We believe iDTECT Blood will contribute to improved antibiotic stewardship and precision medicine strategies in infectious diseases, ultimately leading to better patient care.”
Professor Olivier Lortholary, Professor and Chair of the Department of Infectious and Tropical Diseases at Hôpital Necker-Enfants Malades, Paris, indicated that “In some clinical situations, especially when a patient is immunocompromised, culture and PCR tests are often unable to provide sufficient information to select the most appropriate targeted anti-infective therapy. With the availability of iDTECT Blood, clinicians will be able to expand their experience on the basis of the results already obtained in a proof-of-concept study completed at Necker-Enfants Malades and Européen Georges Pompidou hospitals (Paris, France) on a cohort of over 100 immuno-compromised patients.”
“CE marking of the iDTECT Blood test is a major milestone for PathoQuest. It validates the robustness of our sample-to-BioIT analysis solution, driven by PathoQuest’s proprietary iDTECT database and software” stated Jean-Francois Brepson, PathoQuest’s CEO. “This achievement materializes the leading position of PathoQuest in clinical metagenomics applied to infectiology. We are currently implementing the initial steps of our launch plan to make the test available to selected hospitals in Europe and in the US. We are also progressing towards our goal of establishing key strategic partnerships with companies and institutions which recognize the value of our NGS-based pathogen identification solution.”
Researchers have created a portable and fast-acting test that can distinguish Ebola infections from other fever-causing infectious diseases such as Lassa fever and malaria in around 30 minutes. Although further testing is required, this could be useful during febrile disease outbreaks.READ MORE