Guardant Health has won FDA Emergency Use Authorization for a next-generation sequencing-based COVID-19 test. This is a departure from the Redwood City, CA-based company’s normal modus operandi, as the firm develops liquid biopsy tests to detect cancer.
The Guardant-19 test is a reverse transcriptase-polymerase chain reaction next-generation sequencing (rt-PCR-seq) test that detects coronavirus SARS-CoV-2 nucleic acid from upper respiratory nasal specimens including nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, interior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and nasal washes.
The test has a validated limit of detection (LoD) of 125 copies per mL and results are typically returned the next day. The heavily multiplexed testing workflow used has the ability to scale to over 10,000 tests per day.
Earlier this month, Guardant executives spoke with MD+DI about the COVID-19 test, confirming the company had filed for EUA. Executives noted the company didn’t go into developing the COVID-19 test as an additional business, but more as a civic duty. The firm also noted that it was still strongly committed cancer detection.
“While serving cancer patients remains our top priority, we are proud to be able to leverage our expertise in liquid biopsy testing to contribute to battling the COVID-19 pandemic by offering a highly accurate test that is truly additive to the testing options available today,” said AmirAli Talasaz, Guardant Health president and co-founder said in a release. “Since the beginning of the pandemic we believed it was our social responsibility to not only protect the health and safety of our employees but to also help our greater community with a return to work and school initiatives. It gives me great pride knowing that Guardant Health is able to deliver.”
Guardant said its COVID-19 test is going to be used to help Delaware State University, a Historically Black College & University, reopen safely. The test is also being used for Guardant Health employees and select partner organizations through the company’s CLIA-certified lab.
The EUA comes on the heels of Guardant receiving FDA approval for the Guardant360 CDx. This is the first liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers to obtain approval.
Guardant’s EUA also comes at a time when the Trump Administration has initiated a policy that would eliminate FDA’s ability to regulate lab-developed tests.
A posting from the Department of Health and Human Services said the change in policy was to help safeguard the American people "against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts."