NEW YORK – On Wednesday afternoon, scientist Jonathan Rothberg sat on his lab boat in the northeastern Caribbean, analyzing the future of coronavirus testing. At about 1,500 nautical miles, on a decidedly non-tropical first avenue in Manhattan, New York, the lines stretched for a block as tired people lined up for hours outside a mobile coronavirus test site.
“Want to see my COVID test line? Rothberg asked when a reporter across the Zoom screen told him about the contrast. Rothberg – a DNA sequencing pioneer who once won the National Medal for 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 is my COVID test line. “
Rothberg, 58, is the founder of Detect, a company whose eponymous product holds the promise of a new approach and potentially far superior to the current tangled system. Detect has developed a home diagnostic that uses the most advanced molecular analysis method in the lab instead of the more common – and often ridiculed – home antigen test.
In March 2020, the Connecticut-based Rothberg converted an environmental-themed lab on its superyacht the “Gene Machine” to a COVID-focused lab, raised $ 110 million from undisclosed investors, took on staff – literally – and began researching an efficient but effective way to test for coronavirus at home. He also hired Hugo Barra, former vice president of the virtual reality divisions of Google Android and Meta. As of last week, thanks to emergency clearance from the Food and Drug Administration, a Detect test can be purchased from the company’s website. It costs $ 75 for the “hub” – a device that can be reused for any future detection tests – and an individual coronavirus test.
As he docks in St. Barts for the holidays, Rothberg and several rivals continue to seek the holy grail of coronavirus diagnosis: the speed and convenience of a home test with the precision of a lab test. As their vision takes shape with the rise of the omicron variant, they imagine changing the world of testing in a bigger way. These efforts, they believe, could potentially get consumers to test themselves at home for everything from influenza to sexually transmitted diseases, as part of a practical streamlining of the medical testing process.
“The world has completely changed,” Rothberg said. “We now have telemedicine. People are taking control of their health. They don’t want to go to a lab and wait a week to get a test. And they don’t have to.
The proliferation of omicron during the holiday season has laid bare America’s testing challenges.
More than 200,000 new cases of coronavirus are now documented in the United States every day, but it is surprisingly difficult to be counted among them. Long wait times for molecular lab tests commonly referred to as PCR – hours for getting swabbed, one to two days for results. Meanwhile, home antigen testing (among the types you are likely to find out of stock at your local CVS are Abbott BinaxNOW, Quidel Quickvue, and Ellume) are not only unavailable but teeming with false negatives.
The antigen test is molecular test like a fabric mask is N95. Unlike the molecular process – which looks for genetic evidence, or RNA, to signal the virus – antigenic methods look for antigens that invade the body during infection. This means that it can miss many positive cases – more than 20%, according to many studies. Antigen tests may not catch the virus unless it is strongly replicating, which means it could be missing cases in which a person is infectious but not yet very symptomatic.
This is particularly problematic for omicron, which transmits easily. Experts fear that antigen testing in this wave could allow dozens of home-tested people to go out and unknowingly infect many more, even in the short period before the test catches up. Early reporting of positives – the exact thing antigen testing struggles with – is precisely what is needed for omicron. Additionally, Anthony Fauci, chief medical adviser to President Joe Biden, has suggested that some antigen tests may fail omicron altogether.
Biden promised Americans 500 million home tests on Wednesday. But this will mostly be done through contracts for antigen testing, which could only perpetuate the problem: many more people will receive false negatives and the false sense of security that goes with them, freeing them to infect others.
Detect isn’t the only company to try a different direction.
Cue Health, a publicly traded biomedical company, also recently released a home coronavirus test. It uses a molecular process similar to Detect, creating an “amplification reaction” – essentially, taking the little pieces of RNA and multiplying and extrapolating from them so that they can be scanned for coronavirus. . His product comes in a slightly smoother form than Detect, with a cartridge that a person can insert their swab into. Less than half an hour later, the results are analyzed by Cue’s software and transmitted via Bluetooth to a person’s phone.
Detection involves a bit more liquid pouring by the customer, with a less technological approach that relies on enzymes, not electronics, to create this amplification reaction. It has an app but no Bluetooth; the results are on cell phones in about an hour. Cue’s method involves electrochemistry and a more sophisticated interface that is essentially a miniature PCR machine, produced in its large warehouse in Southern California.
“Right now, people feel the confidence of a lab with a lot of hassle and expectation. Or they feel like they can do it at home with less precision, ”said Ayub Khattak, general manager of Cue Health from San Diego, where the company is based. “Why should they choose? “
Executives say they shipped “millions of tests” in the third quarter as the delta variant peaked, even before omicron. Another home business approved for emergency use by the FDA, Lucira, also uses molecular testing. The test costs $ 75 and uses a similar amplification system known as LAMP.
These tests can be very effective. The Mayo Clinic has found that Cue Health is 98% as sensitive (that is, how many positive tests it gets) as the popular lab PCR. Cue has been used by Major League Baseball and the NBA, both of which require very precise testing which is also very fast. The firm is the official basketball league 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’s also compatible with future testing), while a three-pack of coronavirus tests costs $ 225. A more premium subscription, with full-time access to a doctor via video link, costs an additional $ 50 to $ 90 per month.
Insurance does not pay for home molecular tests. Rothberg says he expects Detect’s price to drop once the scale increases. (The company says it produces tens of thousands of tests every week and hopes to surpass one million soon.) Khattak says the value needs to be taken in context.
“For the price of a gym membership, you get 10 PCR-grade tests and 24/7 access to a doctor for a year,” he said, outlining a plan.
But the question of price is not easily dismissed by experts. Bringing lab technology into the home could, for all its convenience, mean bringing in all the costs as well.
“The science is good for these molecular home tests,” said James Collins, pioneer of synthetic biology and professor at MIT. “But the costs are high in a way that makes me wonder if they can really have the reach they want.”
Collins and his partners have developed their own testing innovations, including a mask that uses freeze-drying technology to detect disease. He hopes it can be marketed in 2022, although more as an early warning tool than a test.
This is not the only innovation of this type. Also at MIT, a new atomic-level test is being researched to further improve accuracy. And at Kyoto Prefectural University in Japan, a researcher, Yasuhiro Tsukamoto, found that ostrich cells would react in a way that could make a mask glow if the wearer had coronavirus.
Home testing raises privacy concerns. Passing health data – not to mention biological material – to a hyper-connected tech company is sure to make some people nervous. (Cue and Detect say they don’t sell any information and also anonymize data before sending tests to health authorities.) More connected home testing makes it easier for authorities to track the spread of the virus, which is currently a challenge.
Experts describe the new technology as part of a testing pattern that always improves without ever being good enough – a dance between insufficiency and innovation.
“I expect the technology to continue to evolve to be more precise, especially as we learn more, but it is also possible that the viral evolution will push us to create ever better technology to keep up with the pace, “said Jennifer Schneider, an expert at the Rochester Institute. of Technology who has studied the tests extensively.
Her colleague, Associate Professor Maureen Ferran, said home molecular testing can be an important tool, but also that antigen testing can be more accurate if “used in conjunction with monitoring for COVID symptoms” and if people self-isolate while waiting for a follow-up lab test. Others point out that as a general indicator, antigen testing always accurately reflects broad trends in coronaviruses.
For those working on these new home tests, however, large-scale accuracy is irrelevant. “Antigen testing is the right answer when you’re talking about 300 million people,” Rothberg said from St. Barts. “But when you talk about your grandmother or an immunocompromised child, you don’t.”
He said his movement was gaining strength as test lines multiplied across the country. A second of his boats moored nearby, the “Gene Chaser”, featured a number of employees continuing their research. Rothberg had bought the “research vessel” as Detect was building up.
“You can do all of that Google research at home, but you can’t get a good test,” he said of what made the company tick. “It shouldn’t be like that.”