San Diego Business Journal

Diazyme Laboratories Inc., the Poway-based life sciences affiliate of General Atomics, has introduced two antibody tests to detect COVID-19. The business made the announcement on March 23.

Its new tests are known as the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits.

Interest in the products has been “overwhelming,” said Dr. Chong Yuan, managing director of Diazyme Laboratories, in a recent interview. He said the business is working to bring a second test — a rapid test — to market, and has notified the Food and Drug Administration about it.

A lab technician can run the tests announced on March 23 on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. Chemiluminescence is light emission that is a product of chemical reactions.

Emergency Use

“To make the tests available, Diazyme followed the FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency …,” Yuan said in a statement issued by the company.

“We thank the FDA for its prompt response to our requests and its guidance in making additional tests available to combat the current novel coronavirus outbreak. Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with our IgM and IgG tests. The fully automated serological tests that we provide have high specificity, sensitivity and clinical agreement with samples confirmed with the standard nucleic acid testing method (RT-qPCR),” Yuan said in the statement.

The tests have yet to be reviewed by the FDA.

Yuan said his company’s antibody tests are complementary to nucleic acid tests. The latter often produce false negatives, he said.

Government notices on GA’s announcement say that results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. In addition, positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Diazyme has a U.S. workforce of about 120, as well as four employees in Germany and 45 in Shanghai. Partners in China helped Diazyme develop its test as the initial coronavirus outbreak took place in that country.

A Range of Diagnostic Tests

Diazyme’s complete product line includes diagnostic blood tests for cardiac markers, diabetes, vitamins and nutritional assessments, liver disease, renal disease and electrolytes. Customers include LabCorp and Quest Diagnostics.

Yuan formed Diazyme in 1999, and partnered with GA in 2000. The business was spun off as a GA affiliate in 2017. GA remains a major shareholder, Yuan said.

Much of General Atomics’ business is military. Its Aeronautical Systems affiliate builds the Predator family of unmanned aircraft in Poway. The business is also developing a new kind of launch and recovery machinery for the U.S. Navy’s latest aircraft carriers.

GA also has its namesake nuclear reactor business, and it runs an experimental nuclear fusion reactor in Sorrento Valley. The latter facility brings in university researchers from all over the world.

General Atomics was founded in 1955 as an arm of General Dynamics. It cycled through a few owners until the Blue family bought it in 1986. The business is privately held and does not disclose revenue.