Hunt is on for more accurate in-home antigen testing – The Washington Post

NEW YORK — On Wednesday afternoon, scientist Jonathan Rothberg was sitting on his boat-laboratory 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 block long, as the masked 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 told him of the contrast. Rothberg — a DNA-sequencing 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 coronavirus test that uses the advanced tool of molecular analysis instead of the more common — and oft-derided — antigen method.
In March 2020, the Connecticut-based Rothberg converted a lab dedicated to environmental studies on his superyacht (named the Gene Machine) to a covid-focused one. He raised $110 million from undisclosed investors, brought some staff onboard — literally — and started researching what he hoped would be an efficient but effective way of testing for the new coronavirus at home. He also enlisted Hugo Barra, former vice president at Google’s Android and Meta’s virtual reality divisions, and established a headquarters in Guilford, Conn., where many employees now work.
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 a pack that includes the “hub” (a reader-like device that can be reused for any future Detect test) and one individual coronavirus test. Bought separately a hub is $39, with each test costing $49.
As he docks in St. Barts for the holidays, Rothberg and several rivals are continuing to reach for the coronavirus-diagnostic holy grail: the speed and convenience of an at-home test with the accuracy of a lab one. While their plan is taking shape during omicron, they dream of a much bigger shift. They hope consumers eventually can test themselves at home for everything from the flu to sexually transmitted diseases, in a kind of radical reshaping 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.”
The mushrooming of the omicron variant during the holiday season has laid bare America’s testing challenges.
More than 200,000 new coronavirus cases are now being documented in the country every day, yet it’s surprisingly hard 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 tests (among the brands you will probably find to be out of stock at your local CVS are Abbott BinaxNOW, Quidel QuickVue and Ellume) are not only unavailable but are also rife with false negatives.
The antigen test is basically to the molecular test what a cloth mask is to the N95. Unlike the molecular process — which searches for elusive genetic evidence, or RNA, signaling the virus — antigen methods look only for the antigens that invade the body during an infection. That means it can miss many positive cases — more than 20 percent, according to numerous studies. Antigen tests may not catch the virus unless it’s already replicating heavily, which means it could miss instances in which a person is infectious but not wildly symptomatic.
That’s especially problematic for omicron, which transmits easily. Some experts worry antigen tests in this wave could allow scores of people testing at home to go out and unknowingly infect many others, even in the short period before the test catches up. Flagging positives early — the exact task antigen tests struggle with — is precisely what’s needed for omicron. The variant’s possibly higher rate of asymptomatic spread increases this danger. What’s more, Anthony S. Fauci, the chief medical adviser to President Biden, has suggested that some antigen tests may miss omicron entirely.
This week, Biden promised Americans 500 million at-home 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 them, setting them loose to infect others.
Detect isn’t the only company going in a different direction.
Cue Health, a publicly traded biomed firm, also recently released an at-home coronavirus test. It uses a molecular process similar to Detect’s, creating an “amplification reaction,” in which small bits of RNA are multiplied in such a way that they can be scanned for coronavirus evidence. (Cue’s electronics-based swab-cartridge-reader system is slightly slicker than Detect’s.) 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, and results come to cellphones in about an hour. Cue’s method, by contrast, draws on electrochemistry to create what it 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 National Basketball Association, both of which require fast, high-accuracy tests. The firm is the basketball league’s official tester this season; when Luka Doncic or Kevin Durant test 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 for other diseases), with a three-pack of coronavirus tests running $225. A more premium “subscription,” with full-time access to a doctor by videolink, costs an extra $50 to $90 per month.
Insurance does not pay for at-home molecular tests. But Rothberg says he expects Detect’s price to drop once the firm’s scale increases. (The company says it is producing tens of thousands of tests each week and hopes to soon reach into the millions.) Khattak says Cue’s 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, also mean bringing all the costs with it.
“The science is good for these molecular at-home tests,” said James Collins, an MIT professor and synthetic-biology pioneer. “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 the coronavirus. 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 in the works. Also at MIT, a new atomic-level 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 was positive.
At-home molecular tests do bring privacy concerns. Handing over health data — never mind biologic material — to a hyper-connected tech company will probably make some people nervous. (Cue and Detect say they do not sell any information and de-identify data before sending to health authorities.) A more connected form of at-home testing does make it easier for officials to track the virus’s spread, otherwise a challenge.
Experts describe the new tech as part of a pattern in which tests continually get better without ever being perfect, 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 that at-home molecular tests are a welcome development but that antigen tests can also be more accurate if “used in conjunction with monitoring for symptoms of covid” and if people isolated and followed up with a lab test. Others point out that, as a general indicator, antigen tests still reflect broad coronavirus trends.
For those working on new at-home tests, however, large-scale accuracy may be 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 the at-home movement was gaining strength as testing lines multiplied around the country. A second boat docked nearby, the Gene Chaser, featured a number of staffers continuing research. Rothberg had bought the yacht and christened it a “research vessel” as Detect ramped up.
He contemplated the company’s mission. “You can do all this Googling at home, but you can’t get a good test,” he said. “It shouldn’t be that way.”