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Anitoa Systems Molecular Monkeypox Test Receives CE Mark

NEW YORK – Anitoa Systems announced on Wednesday that its PCR-based test for monkeypox has received CE marking.

The assay runs on Anitoa's Maverick qPCR system and uses an extraction-free multiplex reagent to test orthopoxvirus and monkeypox gene targets in skin lesion samples from patients suspected of monkeypox infection. The test is designed to be used at the point of care with no need to transport samples to a central laboratory, Anitoa said in a statement.

The Sunnyvale, California-based company said that it has started deploying the test in selected clinics in Africa. The assay is part of the company's ongoing program to develop tests for neglected tropical diseases in low resource settings, such as dengue, yellow fever, and malaria.

Anitoa's portable Maverick instruments can operate on battery power and rely on the firm's proprietary complementary metal-oxide-semiconductor (CMOS) biosensor technology for fluorescence and chemiluminescence molecular imaging. The qPCR instrument received CE marking in December 2020 and is registered and listed with the US Food and Drug Administration as a Class II 510(k)-exempt medical device.

All of the firm's qPCR instruments have CE marking under the EU's new In Vitro Diagnostic Regulation rules, although the moneypox test received CE marking under the old In Vitro Diagnostic Directive rules, a spokesperson for the company said via email. The new rules, which went into effect at the end of May, have more stringent requirements for certification. 

Multiple diagnostic companies and laboratories have begun developing and rolling out monkeypox tests in the past month, including Becton Dickinson, Cepheid, Altona Diagnostics, and CerTest Biotec.