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FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. ....
Study finds significant variation in biomarker test utilization and treatment for non–small-cell lung cancer Biomarker testing surveys specific disease-associated molecules to predict treatment response and disease progression; however its use has complicated the diagnosis of non-small-cell lung cancer (NSCLC). In a new study in The Journal of Molecular Diagnosis, published by Elsevier, investigators provide for the first time a complete overview of biomarker testing, spanning multiple treatment lines, in a single cohort of patients. Using exploratory data analysis and process-mining techniques in a real-world setting, investigators identified significant variation in test utilization and treatment. They also found that while whole-genome sequencing, in which a patient s unique DNA is mapped at once, may not be a cost saving alternative to biomarker testing, as some have suggested, it may have other benefits for patients, such as decreasing the time between test ....
New strategy may change the course of evolving COVID-19 pandemic Launched in April 2020 by the World Health Organization (WHO), European Commission, France and The Bill & Melinda Gates Foundation, the ACT Accelerator is a partnership of leading public health agencies with equity at its heart. In under a year, the ACT Accelerator has driven real progress to accelerate the end of the COVID-19 pandemic. It has accelerated the development of COVID-19 tests, treatments, vaccines and health systems and transformed the ability to tackle COVID-19 on a global scale, but only if the world can ensure the equitable distribution of these vital tools. ....
Warning signs for Alzheimer's disease (AD) can begin in the brain years before the first symptoms appear. Spotting these clues may allow for lifestyle changes that could possibly delay the disease's destruction of the brain. ....
The COVID-19 pandemic has taken a heavy toll on human lives, with over two million casualties so far. Equally devastating has been its economic toll. Now, a new study describes the features and frequency of long-haul symptoms in COVID-19. ....