FDA Expands Access to Coronavirus Test

The U.S Food and Drug Administration (FDA) announced an Emergency Use Authorization (EUA) to enable expanded use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel.

This EUA was issued on February 4, 2020, outlining the use of the 2019-nCoV Real-Time RT-PCR Diagnostic Panel for patients who meet the CDC’s criteria for 2019-nCoV testing.

This diagnostic is a reverse transcriptase-polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, using nasal or oral swabs.

A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their healthcare provider to manage their symptoms and determine how to best protect the people around them.

Furthermore, negative test results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The CDC says ‘the 2019-nCoV is not that same as the coronaviruses that commonly circulate among humans and cause mild illness, like the common cold.

Moreover, a diagnosis with coronavirus 229E, NL63, OC43, or HKU1 is not the same as a 2019-nCoV diagnosis.

These are different viruses and patients with 2019-nCoV will be evaluated and cared for differently than patients with common coronavirus diagnoses, says the CDC.

“Since this (2019-nCoV) outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release.

This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting public health.”

Most patients confirmed with a 2019-nCoV infection have developed a fever and/or symptoms of acute respiratory illness.

However, limited information is currently available to characterize the full spectrum of a clinical illness associated with 2019-nCoV infection.

The FDA can issue EUAs to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing such disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS).

During January 2020, HHS Secretary Alex Azar declared a public health emergency recognizing the potential threat that 2019-nCoV poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat.

As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of 2019-nCoV, it was determined by the HHS that a EUA was crucial to ensure timely access to diagnostics.

Additionally, the FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak.

The FDA said ‘ the agency is dedicated to actively working with other 2019-nCoV diagnostic developers to help accelerate development programs and requests for EUAs. In fact, several have already requested and received the EUA template for this outbreak.

EUA Background:

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents when there are no adequate, approved, and available alternatives.

The FDA is an agency within the U.S. Department of HHS, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Coronavirus Testing news published by Coronavirus Today.