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Curetis Receives Malaysia, Thailand Regulatory Approvals

NEW YORK (GenomeWeb) – Curetis announced today its distribution partner, Acumen Research Laboratories, has received its first approvals to market certain of its products in Malaysia and Thailand. The approvals are expected to further the commercial rollout of Curetis' Unyvero automated molecular diagnostic platform.

Specifically, Singapore-based Acumen has won approval to market the Unyvero BCU Blood Culture Application Cartridge in Thailand and the Curetis Hospitalized Pneumonia Application Cartridge in both Malaysia and Thailand. Both cartridges run on the Unyvero system.

With the new approvals, the pneumonia panel is now fully registered as an IVD medical device in Singapore, Malaysia, and Thailand, Curetis noted in a statement.

"The further regulatory approval of several Unyvero Application Cartridges in Asian markets beyond the Singapore bridgehead have the potential to contribute to further growth of our Unyvero business in the entire [Association of Southeast Asian Nations] region," Curetis CEO Oliver Schacht said in a statement.

The firm is now preparing for a significant commercial expansion of its Unyvero portfolio in Asia in the coming years, Schacht said, with expectation of a near-term regulatory submission to the Chinese National Medical Product Administration for the Unyvero HPN Application by its partner Beijing Clear Biotech, as well as further clinical studies supporting market access in China and beyond.

Acumen and Curetis intend to submit additional Unyvero Application Cartridges for regulatory approval in the ASEAN markets to further the commercial roll-out of Unyvero in the region, the firm said.

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