Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.

HONG KONG – A new algorithmic module developed by Rsip Vision Ltd. makes it possible to generate automated expert-level assessment of heart functions, facilitating quick and reliable detection of cardiac illness and heart attacks.

The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw.

Two-Photon Research Inc. (TPR) has launched a diagnostics platform it said improves coronavirus detection via aptamers, small molecules that change shape when binding to a protein at the surface of the SARS-CoV-2 molecule that causes COVID-19. Light shone onto a vial containing a patient’s saliva and the Aptamer Molecular Photonic Beacon (AMPB) generates negative or positive results that are instantly displayed on a smartphone and stored for planning purposes by public health officials.

Coagulo Medical Technologies Inc. raised $6.5 million in financing to accelerate delivery of its precision-medicine coagulation diagnostics platform. 20/20 Healthcare Partners led the investment with participation from Sands Capital, Good Growth Capital, IAG Capital Partners, and private investors. The company also received funding through a Small Business Innovation Research (SBIR) grant from the National Science Foundation to develop a COVID-19-related coagulation test.

LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot field study indicated sensitivity is less than 40%, and a nationwide roll out already is in train. At present 116 areas of the country are due to implement community testing from next month, health care workers are due to be handed personal LFT supplies to test themselves twice a week, and the government is about to mandate use of the tests in schools after Christmas.

Heru Inc., a medical technology company using artificial intelligence (AI) to advance vision diagnostics and augmentation, has completed class I device registration with the U.S. FDA for its cloud-based diagnostic application for visual field exams. Heru’s software works with commercially available augmented reality or virtual reality (AR/VR) headsets to provide a subjective visual field exam, with results immediately available to clinicians through a web portal.

HONG KONG – A research team at the Chinese University of Hong Kong (CUHK) has developed a fully automated, low-cost and rapid microrobotic diagnostic system that can be used with multiple pathogens, including COVID-19. The system works by integrating fluorescent microrobots with an external magnetic actuation system to detect pathogens in patient samples.