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.

Clinical-stage oncology company Nuview Life Sciences Inc. is developing a cancer diagnostic test and treatment delivery system that could reduce the need for costly, less accurate tests and surgical biopsies. The binary – yes/no – test employs a proprietary peptide construct, NV-VPAC1, that targets a specific receptor, called vasoactive intestinal peptide receptor type 1 (VPAC1), that is overexpressed on the surface of cancer cells.

TORONTO – Waterloo, Ontario-based health startup Kenota Inc. has raised $9 million in series A funding to develop an in-clinic allergy test that takes less than 30 minutes and requires only a few drops of blood from a mild finger prick. This brings the total investment to $11 million for a point-of-care system that detects antibodies signaling allergies to egg, milk and peanuts and that will eventually search out environmental allergies to bee stings and shellfish.