Exclusive: Eyeing big Covid-19 testing expansion, Ginkgo rolls out 50M rapid antigen diagnostics
In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.
The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.
The tests can immediately be used for surveillance, where schools, offices or communities can monitor for outbreaks, as some places now do with wastewater testing and other technologies. With an EUA, it could also be used to give individual yes/no answers.
Ginkgo’s new Covid-19 automated, Illumina-equipped testing facility in Boston, set to open next month
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Ginkgo CEO Jason Kelly said he envisioned deploying the tests in communities in the same way some northeast colleges used once or twice-a-week testing to safely reopen in the fall. He noted the US doesn’t even have the capacity now to test a fraction of schools.
“If you look, in the US, it’s 20 million students and staff associated with colleges. So if you were testing them twice a week, it’d be about 5 million a day, and our national capacity for testing right now is a million tests a day,” Kelly told Endpoints News. “So if you’re going to actually do something like what was done for a small number of colleges nationwide, you’ve gotta bring online stuff like this.”
A decade-old upstart out of MIT, Ginkgo grew to unicorn status at the tail end of 2019 off the robotic factories it built to scale synthetic biology, supporting applications on everything from fertilizer and perfumes to novel antibiotics and engineered microbes.
During the pandemic, though, the company has concentrated its efforts on diagnostics. Most prominently, in the spring, they unveiled plans to use their array of Illumina sequencers as a new kind of diagnostic. With backing from the NIH’s RADx initiative, Ginkgo has built a new automated factory dedicated to that purpose in Boston. Once online next month, it should be able to process about 100,000 tests per day, or a full 10% increase in the nation’s current testing capacity.
Ideally, Kelly said, they’d like to eventually use it for front-end pool testing, where a school or an office mixes samples from, say, 10 different people and tests them all together in an effort to get a broad sense of whether there’s an outbreak.
“What you’re really seeing now is people put like 6 swabs in a tube and ship it to the lab,” Kelly said, laughing. “But that’s a start. In a perfect world they would also figure out how to get the swabs out of there and just send a sample to the lab that didn’t have swabs. But it’s starting to happen.”
In the meantime, they’re pushing forward with the antigen plan. The tests they are now rolling out hold the same drawbacks that have swirled around antigen tests for months: the potential for too many false positives and too many false negatives. (Kelly, echoing experts like Harvard epidemiologist Michael Mina, thinks the negatives aren’t much of a concern, as we’re already missing everyone we don’t test, though he thinks the positives are worth watching. “If you’re quarantining 5% of your workforce every day, it’s not going to work,” he said.)
Ginkgo also reviewed the paper tests that E25Bio develops and that Mina has been pushing as a way to test nearly every American every day. They decided, though, that those weren’t yet read to scale — one of the key advantages of the SD Biosensor tech. Unlike some of the antigen tests from BD or Quidel, the SD Biosensor tests require a much simpler device to read. That could allow for much broader manufacturing and distribution, similar to the Abbott tests recently purchased en masse by the government.
The reader “basically creates a bottleneck in how many tests you can actually do per day,” Kelly said. “If you can do it without a reader then your bottleneck is pretty much how many you can manufacture.”