Medtech Insight: global medical technology news & analysis
Warning Letter Close-Outs – February 2021
01 Mar 2021
No device-related close-out letters were released by the US FDA last month.
Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.
Biomedical researchers are developing countermeasures – including diagnostics – at federal agencies to detect the 2019 novel coronavirus, using prior test platforms for disease outbreaks of SARS-CoV and MERS-CoV as prototypes, the director of the National Institute on Allergy and Infectious Diseases (NIAID) said this week.
NIAID chief Anthony Fauci and two other infectious-disease researchers described efforts to date at the Centers for Disease Control and Prevention (CDC) to develop a new coronavirus assay in China and the US in a recent Journal of the Medical Association (JAMA) editorial, as health authorities reported on 24 January that a Chicago woman who had traveled to Wuhan province in China – where the virus originated – has also tested positive for the disease.
In addition to the news about the second patient stricken with the coronavirus, as of 24 January there are 63 cases being monitored in the US in at least 22 states, says Nancy Messonnier, director of the CDC’s National Center for Immunization. She added that the new patient, a woman in her 60s, is stable, but has been isolated in a Chicago-area hospital as a precaution, after public health officials positively identified the first known US carrier of the disease in Seattle, WA, on 21 January.
Will The Coronavirus Become An Epidemic?
“The situation with 2019-nCoV is evolving rapidly, with the case count in China currently growing into the hundreds,” wrote the NIAID’s Fauci and his co-researchers, Catharine Paules of Penn State University’s Infectious Disease Division and Hilary Marston, another NIAID bioresearcher and a JAMA policy advisor.
“The extent, if any, to which the transmission of 2019-nCoV might lead to a sustained epidemic remains an open and critical question,” the authors noted.
“So far, it appears that the fatality rate of 2019-nCoV is lower than that of SARS-CoV (severe acute respiratory syndrome coronavirus) and MERS-CoV (Middle East respiratory syndrome); however, the ultimate scope and effects of the outbreak remain to be seen,” they added.
One example of the research community’s response to the most recent coronavirus outbreak, is that platform diagnostic modalities are being rapidly adapted to include 2019-nCoV, which would allow for early recognition and isolation of cases. As far as treatments, broad-spectrum antivirals – including remdesivir and RNA polymerase, as well as lopinavir/ritonavir – have shown promise against MERS-CoV in animal models and are also being assessed for activity against 2019-CoV, the bioresearchers wrote.
Medtech Insight: global medical technology news & analysis
01 Mar 2021
No device-related close-out letters were released by the US FDA last month.
Medtech Insight: global medical technology news & analysis
By Sue Darcey 01 Mar 2021
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.
Medtech Insight: global medical technology news & analysis
By Reed Miller 01 Mar 2021
Local Medicare carrier Novitas met with monitoring companies to discuss rates for long-term ECG monitoring, but no final decision on...
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