Coronavirus company news summary - PathogenDx obtains CE mark for microarray assay - IIT Bombay researchers develop test for disease severity - Verdict Medical Devices
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Coronavirus company news summary – PathogenDx obtains CE mark for microarray assay – IIT Bombay researchers develop test for disease severity

22 Jul 2021

PathogenDx has obtained the CE-IVD mark allowing the sale and supply of its DetectX-Rv Microarray Assay for Covid-19 in Europe. The test is designed to identify SARS-CoV2 within three hours following RNA extraction using nasopharyngeal swabs and nasal aspirate or fluid. DetectX-Rv, which could analyse several samples simultaneously, has a 100% specificity. It also holds Emergency Use Authorization (EUA) in the US.

A research team led by the Indian Institute of Technology Bombay has developed a blood test to identify Covid-19 patients who can potentially develop serious symptoms. The test is expected to aid hospital triage by enabling healthcare workers to prioritise patients for hospital and intensive care admission. It leverages the attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) method to measure changes that severe Covid-19 causes in blood biochemistry.

China-based Joysbio has reported that its rapid Covid-19 antigen test showed the ability to identify new SARS-CoV-2 variants, including the Delta (B.1.617.2), Alpha (B.1.1.7), Gamma (P.1) and Beta (B.1.351) variants. A clinical analysis of 492 samples in Italy demonstrated a 98.13% sensitivity and 99.22% specificity with the test, which delivers results in 30 minutes. More than 100 million kits of the test have been sold in Europe for personal and professional application.