FDA Issues First EUA for Antigen-Focused COVID-19 Diagnostic Test: Goal Contribute to Dynamic & Comprehensive Testing Capability

May 9, 2020 | Antigen Test, COVID-19, Diagnostics, Emergency Use Authorization, EUA, FDA, Testing

FDA Issues First EUA for Antigen-Focused COVID-19 Diagnostic Test: Goal Contribute to Dynamic & Comprehensive Testing Capability

The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. Apparently, this class of diagnostic test can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. Issued to Quidel Corporation for the Sofia 2 SARS Antigen FIA, the test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Other nations such as Taiwan and Germany have evidenced that to transition the nation out of a COVID-19-based lockdown, a systematic and pervasive testing regime must be in place. Hence a pillar of the American response to COVID-19 must include high quality diagnostic testing—this is a high priority for the FDA and obviously a directive behind this most recent—and first—EUA for an antigen-based test.

To Date, FDA Issues EUA for Two Types of Test

The FDA has issued EUAs for two types of tests during the pandemic, including 1) polymerase chain reaction (PCR) tests, and 2) Serological tests. PCR tests are a molecular diagnostic testing technique that detects genetic material from the virus and can diagnose an active COVID-19 infection. While on the other hand, Serological tests look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus as part of either an active infection or a prior infection—the FDA notes that serological (or antibody) tests should not be employed to diagnose active infections.

An Antigen Test

Now the FDA issues an EUA for a different class of diagnostic test known as an antigen test. These are utilized for rapid detection of the virus that causes COVID-19.

Strengths for each Class of Test

Each test type or class has a specific and unique role in support of the war against the COVID-19 pandemic. For example, PCR tests are, according to the FDA news release, highly accurate—however, conducting these tests as well as analyzing the results is time consuming. The antigen test, on the other hand, can be employed rapidly for fast results—literally within minutes. But the antigen test has a downsize: they may not detect all active infections and are no where nearly as sensitive as the PCR test. Hence positive results from the antigen test is highly accurate, but there is a higher chance of false negatives. Antigens are important though as they can be produced at a lower cost than PCR tests, and as multiple manufacturers enter the market, these tests can scale to millions of Americans per day due to a simpler design. Antigen tests fit into the FDA’s strategy that this low-cost test can be made in the millions over time and contribute to helping the country better identify infection rates closer to real time.

More EUAs to Come

Although this is the first such antigen test to be approved via the EUA process, the FDA expects more to come. The regulatory agency also announced that they would provide an EUA template for antigen tests, comparable to ones released for the other types of tests. The goal: help manufacturers streamline submissions and help expedite the agency’s review and issuance of additional EUAs.

The Company

Quidel Corporation (Nasdaq: QDEL) is a major American diagnostic manufacturer operating worldwide. Founded in 1979, they are based in San Diego, California. The company is 40 years young, with commercialized products in the healthcare market since 1984. Originally known for lateral flow products used in physician’s offices, our product lines have expanded through robust product development to include tests in infectious disease and reproductive health that are used in hospitals, reference labs, and clinics as well. Their current products fall generally into these categories: (1) lateral flow, where we are market leaders in infectious disease and reproductive health; (2) direct fluorescent antibodies (DFA), with expertise in infectious disease and virology; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent immunoassay products (Sofia); and (4) molecular diagnostic products. Whether at their headquarters in San Diego, California, at their research and manufacturing operations in Ohio, Massachusetts, and Germany, or through the company’s Commercial organization around the world, the Company is delivering a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody testing to molecular diagnostic tests that further improve the quality of healthcare.

Business & Finance

Publicly traded, Quidel’s shares trade at $158.60 for a market capitalization of $5.98 billion. The stock price is at near historic highs. With about $562 million in annual revenue, they drive an expected $177 million in profits. The company holds about $53 million cash in bank. 

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