Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

ChatGPT Does As Well As Humans Answering Genetics Questions, Study Finds

Researchers in the European Journal of Human Genetics had ChatGPT answer genetics-related questions, finding it was about 68 percent accurate, but sometimes gave different answers to the same question.

Sequencing Analysis Examines Gene Regulatory Networks of Honeybee Soldier, Forager Brains

Researchers in Nature Ecology & Evolution find gene regulatory network differences between soldiers and foragers, suggesting bees can take on either role.

Analysis of Ashkenazi Jewish Cohort Uncovers New Genetic Loci Linked to Alzheimer's Disease

The study in Alzheimer's & Dementia highlighted known genes, but also novel ones with biological ties to Alzheimer's disease.

Tara Pacific Expedition Project Team Finds High Diversity Within Coral Reef Microbiome

In papers appearing in Nature Communications and elsewhere, the team reports on findings from the two-year excursion examining coral reefs.