Guardant Health just announced they received emergency use authorization from the FDA for a COVID test
On the recent earnings call, they mentioned that they had developed a saliva test that was only being used for employees, but they mentioned that they were willing to roll it out more to help others test for COVID. They said on the call they weren’t looking to profit off of it, but would only hope to not lose money on it.
The details in the PR seem to refer more to “nasal” test which sounds more like the common tests we’ve seen during the pandemic, rather than using saliva, but maybe it’s the same thing.
At least one school, Delaware State University, is using the Guardant COVID test for students returning to campus.
The one potential business positive on this, and I am just wagering a guess here, is even if they don’t plan to profit off the COVID test, if they previously recognized a lot of costs related to development of the test without anticipating related revenue, and rolling it out beyond just the employee base brings in enough future revenue just to break even (not to lose money), they may ultimately recoup a lot of previously recognized costs and essentially show net profit on this test going forward, resulting in a breakeven since inception situation. So even without an ultimate profit relating to COVID tests, it’s not outside of the realm of possibility that there could be a minor windfall/profit for them in the second half of 2020. We’ll see
REDWOOD CITY, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) – Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees and select partner organizations through the company’s CLIA-certified clinical laboratory.
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.
“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,”