Today, the State of Nevada announced it has received notification from the Food and Drug Administration (FDA) to take responsibility to determine the quality of newly developed COVID-19 test kits and kit components, one of three states to earn the flexibility from the FDA.
According to a press release from the Nevada Health Response press room:
The ability of the State to develop, assess and conduct its own testing is a positive step which will increase capacity to test for the virus causing COVID-19.
The State is looking for every opportunity to protect the health of its citizens and the ability to develop testing will benefit our response to this public health issue.
“This change in Nevada’s status will allow the State of Nevada, not the FDA, to determine whether products associated with testing are safe and effective for testing,” said Dr. Mark Pandori, director of the Nevada State Public Health Laboratory. “This means that when labs in Nevada do validation studies on products to determine whether they are effective prior to launching testing, they can submit their findings to the state, not the FDA, for approval. This is a much faster process. By the end of next week, we should have data on novel products for testing that should increase testing capacity considerably.”
While this does not mean every citizen will be tested immediately, it does give the state’s health care providers more accessibility to prioritize testing of those with serious symptoms, as well as the key populations of vulnerable citizens and health care workers most likely to have come in contact with COVID-19. As there is not yet a treatment for COVID-19, it has been advised that those with mild symptoms do not need to be tested.
The NSPHL has the capacity to test patients for weeks, and will continue doing so while it is evaluating new products for use in testing.
“I am proud that Nevada has taken this step and I commend our labs for their ongoing work to bring peace of mind to Nevadans through testing for COVID-19,” said Governor Steve Sisolak.
Nevada is among three states capable of assessing products and components on its own. States indicated by the FDA to have developed their own systems of evaluation can be found here https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.
