By Marie Rosenthal, MS

The need for novel coronavirus testing is great in the United States, and the government is responding by encouraging diagnostic companies to develop tests under the FDA’s Emergency Use Authorization (EUA) process. 

GenMark Diagnostics Inc. submitted an EUA to the FDA for its ePlex SARS-CoV-2 test, which tests for the novel coronavirus that causes COVID-19, and is expecting to receive a response quickly. Test results would be available in less than two hours. 

The ePlex SARS-CoV-2 test is a rapid diagnostic test that can be run in hospital laboratories instead of sending the test out to larger diagnostic laboratories, which is required for the two currently cleared FDA tests by Roche and Thermo Fisher.  Those tests are high-throughput, high-complexity tests that require specially trained technicians to run usually at very large centralized hospital or reference labs. 

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The ePlex system is easy to use, with less than 2 minutes of hands-on time. This means the ePlex test can be run by almost any laboratory with an ePlex system, and new clients could be brought up to speed quickly. 

Additionally, the ePlex system enables truly rapid testing, as in most cases, the test is sent to the on-site lab where it can be run in about 1.5 hours. Results can be given quickly to the pharmacist or clinician rather than waiting 24 to 48 hours or more for other test results.

GenMark shipped initial Research Use Only (RUO) tests on March 2 to several key hospitals and laboratories to validate the assay design using clinical samples. This was the first rapid sample-to-answer test available for RUO testing, according to company officials.

“Our priority was to help our customers address this global health emergency. We leveraged our adaptable and easy-to-use ePlex platform to quickly design and manufacture a test to accurately detect this highly contagious virus in clinical samples,” said Scott Mendel, the interim CEO.

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Dwayne Breining, MD, the executive director of labs at Northwell Health in New York, one of the RUO testing sites, said managing the level of testing coming in to hospitals is a real challenge.

“Getting tests to detect COVID-19 in the hands of our physicians and clinicians as soon as possible is one of our highest priorities in combating this rapidly expanding health emergency,” Dr. Breining said. 

This is what GenMark has been hearing from other clients, too. “We are hearing from our customers that since test results are rapid with ePlex, they are using it for more urgent testing of inpatients, ICU patients and health care providers with direct contact with patients. While they are using the other platforms for outpatients and those without symptoms,” Lisa Filippone, the director, Global Product Marketing at GenMark Diagnostics, told Infectious Disease Special Edition.

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The FDA issued EUAs to Roche Diagnostics for its Cobas COV-2 test and to Thermo Fisher for its TaqPath COVID-19 Combo kit, and is working with several other test developers. 

In addition, more than 30 laboratories have notified the FDA that they are testing or intend to begin testing soon under the FDA’s new policy for laboratory-developed tests. 

The FDA is working to quickly review and authorize diagnostics, according to FDA Commissioner Stephen M. Hahn, MD. “We have been engaging with test developers and encouraging them to come to the FDA and work with us.”

The agency updated a policy on diagnostic testing for SARS-CoV-2 to increase U.S. testing capacity. States can now take responsibility for tests developed and used by laboratories in their states. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. These laboratories would not pursue an EUA with the FDA, such as GenMark is doing. 

GenMark’s request for an EUA is under review by the FDA. If the FDA concludes that the criteria for issuance of an EUA have been met, the company will begin shipment of test kits to its customers for routine clinical use.

“GenMark is an important Northwell partner in molecular diagnostics, and we are grateful to their team for continuing to push forward a test that can rapidly identify patients with SARS-CoV-2,” Dr. Breining said.