NEW YORK – Anitoa Systems has received the CE-IVD mark for its Maverick portable qPCR instrument. The Sunnyvale, California-based medical device company will now be permitted to commercialize the system within the European Union and other countries that recognize the CE mark.
"We are excited to now offer laboratories in the EU and other international markets a portable solution for rapid and on-site nucleic acid [testing] to help combat diseases such as COVID-19," Zhimin Ding, CEO of Anitoa Systems, said in a statement.
The Maverick instrument enables multiplexed nucleic acid detection using proprietary complementary metal-oxide-semiconductor (CMOS) four-channel fluorescence optics, the firm said, supporting testing without the need for calibration in the field. The instrument is also paired with cloud-based software that allows for cloud storage and retrieval of data.
"We believe our portable qPCR instrument and its associated [software] 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," Ding said. The firm previously said its instrument would cost in the range of $3,500 to $6,000, depending on the number of optical channels.
Anitoa said it has demonstrated the Maverick system for the detection of hepatitis B and C, HIV, African Swine Flu, influenza A and B, and SARS-CoV-2. The instrument has been shown to reliably detect three copies of pathogen genome per sample, with over 10 orders of magnitude in dynamic range, according to the firm.