The CE Mark confirms that the Company's Maverick series products meet the requirements of the European In-Vitro Diagnostic Devices Directive and allows Anitoa to commercialize its kits throughout the European Union and other CE Mark geographies
Anitoa Systemc, market leader in rapid, portable PCR-based molecular testing, has announced the award of CE (Conformité Européene)-IVD Mark for its Maverick series portable qPCR instruments. The CE Mark confirms that the Company’s Maverick series products meet the requirements of the European In-Vitro Diagnostic Devices Directive and allows Anitoa to commercialize its kits throughout the European Union and other CE Mark geographies.
Maverick is packed with technology innovations from Anitoa, a young Silicon Valley medical device company. These innovations include a unique proprietary low-light sensitive, complementary metal-oxide-semiconductor (CMOS) 4-channel fluorescence optics system that allows fast and highly multiplexed DNA detection without the need for field calibration, while reducing cost and footprint. Maverick is further enhanced with a cloud-based software that is seamlessly connected to the Internet and enables cloud data storage and retrieval – another key requirement for deployment of portable instruments.
Applications of Maverick include near-patient in vitro diagnostics, food, agriculture and environment testing, forensics, and basic biological research. Anitoa has previously demonstrated Maverick technology in detecting several types of pathogen DNA and RNA strands, such as Hepatitis B and C, HIV, African Swine Flu, Influenza A and B and SARS-COV-2 (Covid-19). Maverick has been shown to achieve reliable detection of only 3 copies pathogen molecule DNA per sample with over 10 orders of magnitude in dynamic range.
“We are excited to now offer laboratories in the EU and other international markets a portable solution for rapid and on-site nucleic acid to help combat diseases such as COVID-19,” said Dr. Zhimin Ding, CEO of Anitoa Systems. “We believe our portable qPCR instruments and its associated SW solutions offer features that uniquely meet the needs of the EU and other international markets through the highly sensitive detection of key life-threatening pathogens while being extremely cost effective.”
Source: Company Press Release