The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.
Reflexion Medical Inc. appears to be on a roll. A little more than a month after unveiling a tie up with Merck & Co. Inc., it now has reported a collaboration with Telix Pharmaceuticals Ltd., a radiopharmaceutical company developing molecularly targeted radiation products.
RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
Research focused on finding viable solutions to counter the COVID-19 pandemic continues at an explosive pace with a total of 588 potential therapeutics and vaccines at the forefront of scientific efforts launched by industry, academia and government.
Keeping you up to date on recent developments in diagnostics, including: Broad scale genomic testing for childhood illness; Deep learning model for cancer prognosis; Placenta attachment theory.
Researchers working as part of the Quantitative Imaging Biomarkers Alliance (QIBA) have recently validated an open-source algorithm that can be used to measure blood flow using existing 3D ultrasound technology from major manufacturers. They published their results in the June 30, 2020, issue of Radiology.
Chinese scientists at Peking University (PKU) in Beijing have developed a new in vitro patient-derived tumor-like cluster (PTC) model, which predicted the outcomes of neoadjuvant and conventional chemotherapies in colon, gastric and breast cancer patients, with a clinical consistency of >93%.
Thermo Fisher Scientific Inc. is working with Daiichi Sankyo Co. Ltd. to develop a companion diagnostic (CDx) to identify non-small-cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who could be eligible for the Tokyo-based company's cancer drug, Enhertu.
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