NEW YORK (GenomeWeb) – Curetis said today that it has received approval from Singapore regulators for its Unyvero test cartridge for the diagnosis of pneumonia in hospitalized patients.
The PCR-based cartridge is designed to detect 21 pneumonia pathogens and 19 genetic markers of antibiotic resistance, and runs on the company's Unyvero molecular diagnostic instrument. According to Curetis, its Southeast Asian marketing partner Acumen Research Laboratories has been cleared by the the Singapore Health Sciences Authority (HSA) to offer the test.
"This first approval of a Unyvero application in an Asian market serves as a bridgehead to the entire [Association of Southeast Asian Nations] region and marks an important milestone in the commercial growth strategy of Curetis," CEO Oliver Schacht said in a statement.
Curetis said that the HSA is currently reviewing a Unyvero blood culture cartridge for the diagnosis of bloodstream infections, and that tests for intra-abdominal infections and implant and tissue infections are expected to be submitted to the agency for approval.
Additionally, development of a Unyvero sepsis host response cartridge based on a gene expression panel licensed from Acumen has been completed, Curetis said. The companies plan to begin clinical validation studies to demonstrate that the assay offers the same analytical and clinical performance as a lab-developed test that uses the same biomarkers and is currently offered by Acumen in Singapore.
"With an expected near-term clearance decision from the US [Food and Drug Administration] for the Unyvero lower respiratory tract [test] 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," Schacht added.
Earlier this week, Curetis said that it had missed previous guidance on Unyvero instrument placements due a delay that pushed the planned US launch of the system to 2018.