Company News: Curetis Accelerates 510(k) Submission Preparation for Unyvero LRT in BAL Specimen Based on Positive FDA Feedback
— S. FDA and Curetis agree on 510(k) requirements for clearing BAL as additional sample type for Unyvero LRT
— S. commercial roll-out gaining traction, with first dozen Unyvero Analyzers placed and first commercial evaluation agreements signed
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that following a recent meeting, the U.S. FDA has confirmed the suitability of the 510(k) clearance pathway for Curetis’ Unyvero LRT Application Cartridge specifically optimized for the detection of microbial pathogens in bronchoalveolar lavage (“BAL”) samples.
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. Overall, the Company 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.
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.
The Company also reported that the U.S. commercial roll-out of the Unyvero LRT Application Cartridge for tracheal aspirates launched in June 2018 is gaining traction. Since the launch, the U.S. commercial team has qualified about 140 accounts in the top 1,000 hospitals initially targeted with about 80 being deeply vetted. Several accounts have entered into clinical and commercial evaluation agreements and with a dozen Unyvero Analyzers placed beyond FDA trial sites have since then started the on-site evaluation of the Unyvero System and LRT Application Cartridge. These and many further of these vetted accounts are expected to be converted to commercial accounts over the next several quarters with about a dozen accounts constituting near-term opportunities currently at the contract negotiation stage. These initial accounts on average are expected to have Unyvero LRT cartridge volumes of 700 to 800 annually once they become commercial customers with some accounts having significantly higher total potential annual testing volumes. The Company expects to provide an update on target placement numbers for Unyvero Analyzers in the U.S. market around the J.P. Morgan Healthcare Conference in early 2019.
“We are very pleased with the feedback we received during our recent meeting with the FDA,” said Johannes Bacher, COO of Curetis. “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.”
“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,” commented Chris Emery, CEO & President of Curetis USA Inc. “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.”