The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.

The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.

Cvaid Medical Ltd. secured $4 million in a series A financing to further develop its mobile stroke diagnostic, monitoring and treatment platform. The Israeli Rad Biomed investment fund led the round with participation from Philips Ventures and Sanara Capital. As part of the financing, a representative from Philips will join the board. The smartphone-based system, Cvaid uses artificial intelligence to process and analyze video and voice recordings to identify and assess the severity of patients experiencing stroke, also called cerebrovascular accidents.

A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.

PARIS – Ziwig SAS has developed the Endotest saliva test, for quickly detecting endometriosis. François Golfier, head of the gynecology-obstetrics department at Angers University Hospital and chairman of the endometriosis committee for the National College of French Gynecologists and Obstetricians, claims this new generation of in vitro diagnostic medical devices is going to be a game-changer “as it finally allows this chronic debilitating disease to be detected sooner and within the space of just a few days.”

Visby Medical Inc. reeled in more than $100 million in a series E round led by Ping An Voyager Partners. The funds will be used to scale production capacity of Visby’s instrument-free, single-use real-time polymerase chain reaction (RT-PCR) platform from tens to hundreds of thousands of tests per month.

Selux Diagnostics Inc. raised $50 million in a series C financing to support the commercial launch of its next-generation phenotyping (NGP) rapid antimicrobial susceptibility testing platform. RA Capital Management LLC led the round with participation from Sands Capital, Schooner Capital and Northpond Ventures, all returning investors.

Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment.

The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.