The ID Pipeline: FDA Activity From the Week of March 15, 2020
Here is a look at infectious disease-related FDA news from the week of March 15, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of March 15, 2020.
FDA Grants Emergency Expanded Access to Nitric Oxide Delivery System
Bellerophon Therapeutics has announced that the FDA is granting emergency expanded access to allow its inhaled nitric oxide delivery system INOpulse to be used in the treatment of disease caused by the novel coronavirus (COVID-19).
Nitric oxide is important to immune responses against infections. The company cited in vitro studies that show nitric oxide inhibits the replication of the virus which caused severe acute respiratory syndrome, SARS-CoV-1.
In a clinical study of patients with SARS-CoV-1 infections, iNO demonstrated a reduction in the need for ventilation support and improvement in lung infiltrates according to chest radiography.
Read the full press release.
FDA Issues Emergency Authorization For ePlex SARS-CoV-2 Test
The US Food and Drug Administration (FDA) has issued Emergency Use Authorization for the ePlex SARS-CoV-2 test, produced by GenMark Diagnostics. The company announced the authorization Thursday, March 19.
The authorization comes as regulators seek to correct what has been perceived by some as a shortage of testing in the United States.
“Demand for our tests has been extraordinary, especially as centralized testing supply has been limited,” said Scott Mendel, Genmark’s Interim Chief Executive Officer.
The ePlex test detects SARS-CoV-2 RNA using nasopharyngeal swab samples. The test can only be used with the company’s ePlex system, which had a global coverage of over 500 analyzers as of December 31, 2019.
The test automates the diagnostic process, providing results in less than 2 hours. The system has the capacity to process up to 96 tests in an 8-hour period.
Read the full article.
Abbott Receives FDA Emergency Use Authorization for COVID-19 Test
The US Food and Drug Administration (FDA) has issued Emergency Use Authorization for Abbott’s molecular COVID-19 test.
In response to the authorization the company announced that 150,000 of the Abbott RealTime SARS-CoV-2 tests are being shipped within the United States. Tests have already been sent to facilities in 18 states including New York and Washington where the majority of US COVID-19 cases have been recorded.
The tests are utilized on the m2000 RealTime System, a platform which uses polymerase chain reaction technology for rapid diagnosis. More than 175 m2000 systems are used in hospital and laboratories across the United States.
According to Abbott, the systems can run high volumes of up to 470 tests in 24 hours.
The company will also be scaling up production to manufacture 1 million tests per week by the end of March.
Read the full article.