The U.S. FDA confirmed that data required for the submission can largely be based on clinical samples previously collected during the original Curetis U.S. FDA trial for the Unyvero LRT Application Cartridge, Curetis said on Friday.
Curetis believes that U.S. FDA feedback has substantially de-risked the planned submission of the Unyvero LRT Application Cartridge for BAL and that the requirements agreed upon with the Agency should allow Curetis to accelerate generating the required data and prepare for an early submission, with an expected clearance decision in 2019.
BAL is another common method for the diagnosis of lower respiratory tract infections, in which the lower airways are flushed with saline solution. The lavage fluid is then analyzed for the presence of pathogens. Sensitivity of the Unyvero LRT Application Cartridge for BAL has been further optimized for this more diluted sample type. It is estimated that half of the samples obtained for the diagnosis of lower respiratory tract infections are BALs, and Curetis believes that a clearance for this additional sample type would increase the total addressable market for the Unyvero LRT Application Cartridge in the U.S. accordingly, it said.
Furthermore, as part of the 510(k) submission, Curetis also plans to include data on an assay for one additional pathogen, Pneumocystis jirovecii. This fungus is particularly relevant in lower respiratory tract infections in patients with compromised immune status, such as transplant recipients or AIDS patients.
Johannes Bacher, COO of Curetis, said: “We are very pleased with the feedback we received during our recent meeting with the FDA. With the confirmation of the 510(k) regulatory pathway and valuable feedback on the data requirements, we have considerably de-risked this commercially important extension of Unyvero LRT utility to bronchoalveolar lavage samples.”
Chris Emery, CEO & President of Curetis USA Inc.“Our commercial campaign for introducing Unyvero LRT in the U.S. market is gaining momentum, with several accounts having entered into commercial evaluation agreements and a strong pipeline of further near-term commercial opportunities. Once the addition of BAL specimen usage is cleared by the FDA, the Unyvero LRT Application Cartridge for use with these samples will strengthen our position as one of the first movers in syndromic testing for lower respiratory tract infections.”