Company News: Curetis´ Unyvero HPN Application Receives Singapore Health Sciences Authority Approval; Updates on Sepsis Host Response Test

— Market authorization paves way for broader Unyvero commercial roll-out in ASEAN region through partner Acumen Research Laboratories

— Near-term clinical validation study of first cartridge-based molecular test for Sepsis Host Response panel licensed from Acumen in preparation

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that Acumen Research Laboratories Pte Ltd. (Acumen), its partner for the commercialization of Unyvero in the ASEAN region, has received approval by the Singapore Health Sciences Authority (HSA) to market the Unyvero HPN Hospitalized Pneumonia Application Cartridge in Singapore.

With this approval, Unyvero HPN is now fully registered as a Class C IVD medical device with the Singapore Medical Device Register (Device Registration No: DE0501196). After the initial placement of Unyvero Systems under the GN-27 exemption at early adopter sites such as Raffles Hospital, Farrer Park Hospital, and Parkway Laboratories, the HSA approval now allows for a more comprehensive roll-out in Singapore as a bridgehead to the ASEAN region. Acumen expects that the approval in Singapore will facilitate market entry into other countries of the region including Malaysia, Indonesia, and Thailand going forward.

The HSA review and approval process for the Unyvero BCU Blood Culture Application Cartridge as a second application for the Singaporean and ASEAN markets is ongoing. Acumen and Curetis further intend to submit the Unyvero ITI Implant and Tissue Infection and Unyvero IAI Intra-Abdominal Infection Application Cartridges for HSA approval.

Curetis and Acumen also announced that the development of the Unyvero SHR Sepsis Host Response Application Cartridge for the rapid identification of patients with bloodstream infections and sepsis has been completed. The cartridge is based on a proprietary gene expression biomarker panel licensed by Curetis from Acumen in 2015. In the coming months, the Companies expect to initiate clinical validation work on this first cartridge-based rapid molecular test for sepsis alongside a laboratory-developed test (LDT) based on the same biomarker panel already offered by Acumen to hospitals in Singapore. The validation work will focus on demonstrating concordance of the analytical and clinical performance of two tests in the same patient population.

“In only four to five hours, the new Unyvero HPN test enables detection of 21 pathogens and 19 antibiotics resistance markers that are highly relevant for the diagnosis of hospitalized patients with suspected pneumonia. This will not only help to improve outcomes for these patients, but also facilitate the more prudent use of antibiotics and thereby help mitigating the growing antimicrobial resistance challenge,” commented Siew Hwa Ong, PhD, CEO of Acumen. “We are also pleased with the progress of the Unyvero SHR Application Cartridge building on our biomarker panel, as this rapid and easy-to-use molecular test bears great potential in addressing the diagnostic challenges clinicians are facing in treating sepsis.”

“This first approval of a Unyvero Application in an Asian market serves as a bridgehead to the entire ASEAN region and marks an important milestone in the commercial growth strategy of Curetis,” said Oliver Schacht, PhD, CEO of Curetis. “With an expected near-term clearance decision from the U.S. FDA for the Unyvero Lower Respiratory Tract Application and the solid progress we are making with our partner Beijing Clear Biotech with regulatory studies in China, we are setting the stage for significant commercial expansion of Unyvero in the years to come.”