Future of COVID tests taking shape on a yacht
NEW YORK — On Wednesday afternoon, scientist Jonathan Rothberg was sitting on his boatlaboratory in the northeastern Caribbean parsing the future of coronavirus testing. About 1,500 nautical miles away, on a decidedly nontropical First Avenue in Manhattan, the lines stretched a city block as the weary queued up for hours outside a mobile coronavirus testing site.
“You want to see my COVID testing line?” Rothberg asked when a reporter on the other end of the Zoom screen told him of the contrast. Rothberg — a Dnasequencing pioneer who once won the National Medal of Technology and Innovation from President Barack Obama — picked up an oddly shaped white box and placed it on the desk in front of him. “Here, this is my COVID testing line.”
Rothberg, 58, is the founder of Detect, a company whose eponymous product holds the promise of a new and potentially far superior approach to the current tangled system. Detect has come up with an at-home diagnostic that uses the more advanced labbased method of molecular analysis instead of the more common — and oft-derided — at-home antigen test.
In March 2020, the Connecticut-based Rothberg converted an environment-themed lab on his superyacht, the Gene Machine, to a Covid-focused one, raised $110 million from undisclosed investors, brought some staff onboard and started researching an efficient but effective way of testing for the coronavirus at home. He also enlisted Hugo Barra, former vice president at Google’s Android and Meta’s virtual reality divisions. As of last week, thanks to an emergency authorization from the Food and Drug Administration, a Detect test can be bought on the company’s website. It costs $75 for the “hub” — a device that can be reused for any future Detect test — and an individual coronavirus test.
As he docks in St. Barts for the
holidays, Rothberg and several rivals are continuing to seek the coronavirus-diagnostic holy grail: the speed and convenience of an at-home test with the accuracy of a lab one. While their vision is taking shape during the rise of the omicron variant, they imagine changing the testing world in larger ways. These efforts, they believe, eventually could lead to consumers testing themselves at home for everything from the flu to sexually transmitted diseases, in a convenient streamlining of the medical-testing process.
“The world has completely changed,” Rothberg said. “We have telemedicine now. People are taking control of their health. They don’t want to go to a lab and wait a week to get a test back. And they don’t have to.”
Antigen test failings
The mushrooming of omicron during the holiday season has laid bare America’s testing challenges.
More than 200,000 new coronavirus cases are now being documented in the United States every day, yet it’s surprisingly difficult to be counted among them. Long wait times abide for the lab-based molecular tests commonly called PCRS — hours to get swabbed, one to two days for the results. Meanwhile, the at-home antigen test (among the kinds you are likely to find out of stock at your local CVS) are not only unavailable but rife with false negatives.
The antigen test is to the molecular test like a cloth mask is to the N95. Unlike the molecular process — which searches for genetic evidence, or RNA, signaling the virus — antigen methods look for the antigens that invade the body during an infection. That means it can miss many positive cases — over 20 percent, according to numerous
studies. Antigen tests may not catch the virus unless it’s replicating heavily, which means it could miss instances in which a person is infectious but not yet wildly symptomatic.
That’s especially problematic for omicron, which transmits easily. Experts worry antigen tests in this wave could allow scores of people testing at home to go out and unknowingly infect many other people even in just the short period before the test catches up. Flagging positives early — the exact thing antigen tests struggle with — is precisely what’s needed for omicron. What’s more, Anthony Fauci, the chief medical adviser to President Joe Biden, has suggested some antigen tests may miss omicron entirely.
On Wednesday, Biden promised Americans 500 million athome tests. But that will be primarily via contracts for antigen tests, which could only perpetuate the problem: Many more people will be given false negatives and the false sense of security that comes with it, setting them loose to infect others.
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Detect isn’t the only company trying a different direction.
Cue Health, a publicly traded biomed company, also recently released an at-home coronavirus test. It uses a molecular process similar to Detect’s, creating an “amplification reaction” — basically, taking the small bits of RNA and multiplying and extrapolating from them in such a way that they can be scanned for the coronavirus. Its product comes in a slightly slicker form than Detect, with a cartridge into which a person can insert their swab. Less than a half-hour later, the results are analyzed by Cue’s software and beamed via Bluetooth to a person’s phone.
Detect involves a bit more pouring of liquids by the customer,
with a lower-tech approach that relies on enzymes, not electronics, to create that amplification reaction. It has an app but no Bluetooth; results come to cellphones in about an hour. Cue’s method involves electrochemistry and a niftier interface that’s basically a miniature PCR machine, produced at its large Southern California warehouse.
“Right now people feel either the confidence of a lab with a lot of hassle and waiting. Or they feel like they can do it at home with less accuracy,” Ayub Khattak, Cue Health’s chief executive said from San Diego, where the company is based. “Why should they have to choose?”
Executives say they shipped “millions of tests” in the third quarter as the delta variant peaked, even before omicron. Another at-home company approved for emergency use by the FDA, Lucira, also uses molecular testing. The test costs $75 and employs a similar amplification system, known as LAMP.
These tests can be very effective. The Mayo Clinic found that Cue Health is 98 percent as sensitive (that is, how many positive tests it catches) as the highly regarded lab PCR. Cue has been used by Major League Baseball and the NBA, both of which require highly accurate testing that is also very fast. The firm is the basketball league’s official tester this season; when Luka Doncic or Kevin Durant tested positive, it’s because Cue said they did.
But these tests don’t come cheap. At Cue, a reader costs $249 (it too is compatible with future tests), while a three-pack of coronavirus tests runs $225. A more premium subscription, with fulltime access to a doctor by videolink, costs an extra $50 to $90 per month.
Insurance does not pay for athome molecular tests. Rothberg says he expects Detect’s price to
drop once scale increases. (The company says it is producing tens of thousands of tests each week and hopes to soon pass 1 million.) Khattak says the value has to be taken in context.
“For the price of a gym membership, you get 10 Pcr-quality tests and 24/7 access to a physician for a year,” he said, describing one plan.
But the price question is not easily dismissed by experts. To import lab technology into the home could, for all its convenience, means bringing all the costs with it, too.
“The science is good for these molecular at-home tests,” said James Collins, a synthetic-biology pioneer and MIT professor. “But the costs are high in a way that makes me wonder if they really can have the reach they want.”
Collins and his partners have developed several testing innovations of their own, including a mask that uses freeze-dried technology to detect disease. He hopes it can be commercialized in 2022, albeit more as a first-alert tool than a test.
It is not the only such innovation. Also at MIT, a new atomiclevel test is being researched to further improve accuracy.
And at Japan’s Kyoto Prefectural University, a researcher, Yasuhiro Tsukamoto, discovered that ostrich cells would react in a way that could make a mask glow if the wearer had coronavirus.
Inadequacy and innovation
At-home tests bring privacy concerns. Handing over health data — never mind biologic material — to a hyper-connected tech company will certainly make some people nervous. (Cue and Detect say they do not sell any information, and also de-identify the data before sending tests to health authorities.) More connected at-home testing does make it easier for officials to track the virus’ spread, currently a challenge.
Experts describe the new tech as part of a pattern of testing always getting better without ever being good enough — a dance between inadequacy and innovation.
“I expect technology will continue to evolve to be more accurate, especially as we learn more, but it is also possible that viral evolution will push us to create ever better technology to keep up,” said Jennifer Schneider, an expert at the Rochester Institute of Technology who has extensively studied testing.
Her colleague, associate professor Maureen Ferran, said athome molecular tests can be an important tool, but also that antigen tests can be more accurate if they “are used in conjunction with monitoring for symptoms of COVID,” and if people isolate while waiting for a follow-up lab test. Others point out that, as a general indicator, antigen tests still accurately reflect broad coronavirus trends.
For those working on these new at-home tests, however, large-scale accuracy is beside the point. “Antigen tests are the right answer when you’re talking about 300 million people,” Rothberg said from St. Barts. “But when you’re talking about your grandmother or an immunocompromised child, they’re not.”
He said his movement was gaining strength as testing lines multiplied around the country. A second boat of his docked nearby, the Gene Chaser, featured a number of staffers continuing research.
Rothberg had bought the “research vessel” as Detect ramped up.
“You can do all this Googling at home, but you can’t get a good test,” he said of what drove the company. “It shouldn’t be that way.”