bulls schreef op 29 september 2016 10:38:
Ik had een emailtje gestuurd met de vraag over de FDA clearance.
Moet je eens lezen...
many thanks for your e-mail and your interest in our company.
Here a brief overview on Curetis:
Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. So we offer a device platform and disease specific tests, the Unyvero Application Cartridges, for enabling a fast identification of the most relevant pathogens (incl. different bacteria and fungi) as well as antibiotic resistance markers in 4-5 hours. Traditional tests in the Microbiology normally take at least 24-72 hours, but sometimes also several weeks. Having timely and relevant data on most important pathogens and antibiotic resistances available is of high importance in severely ill patients as they have to be treated as fast as possible with adequate antibiotics. Scientific data assumes that in up to 45% of all cases patients are treated with inadequate antibiotics. So summing up, we aim with our tests to deliver relevant information about pathogens and antibiotic resistance markers underlying a certain disease in short time so that clinicians can adjust their treatment regimen earlier, supporting a quicker recovery of the patient and leading to hospital savings.
As you might have seen, there are currently three cartridge-based tests for severe cases in pneumonia, implant and tissue infections and blood culture which are CE-marked and commercially available in Europe.
An abdominal infection test is expected to be completed by end of year 2016. Further applications include, sepsis host response, urinary tract infections, and cardiology associated infections as well as an expanded respiratory panel.
For commercializing diagnostic products in the U.S. it has to be cleared by the FDA. Initially we seek clearance for the Unyvero System and the LRT55 Lower Respiratory Tract cartridge. LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 (HPN = Hospitalized Pneumonia) cartridge marketed outside the U.S.
The FDA approval process for diagnostic tests and platform is different from the process requested for drug approval. Regarding the U.S. FDA timeline, we have publicly guided to the following:
Patient sample enrolment (prospective as well as retrospective samples) has been completed in June 2016. Completion of the comparator analysis including contrived specimen testing is expected in the second half of 2016. Subsequently, data will be un-blinded in fall of 2016 and a statistical analysis will be conducted on all data – we anticipate more than 350,000 data points from this trial, so this needs to be done thoroughly and will take some time.
FDA submission is anticipated before the end of the year, with a goal of securing FDA clearance for Unyvero and commercialization of our products in the U.S. in the first half of 2017. As result we expect a FDA clearance for Unyvero.
The FDA process is a so-called 510k or de novo 510k which has a statutory review process of 90 days, however, in practice can take significantly longer. We simply cannot speculate on the FDA’s actual review timeline and whether they will have questions that require additional data to be submitted before clearance.
I hope we could answer your questions.
You might find it also interesting to take a look at our corporate presentation (http://www.curetis.com/en/pr/downloads.html) and our latest press releases (http://www.curetis.com/en/pr/downloads.html).
With kind regards,
Elena