- US testing capacity for the novel coronavirus is pretty good for symptomatic people.
- But experts are pushing for frequent, cheap tests that anyone can use from the comfort of their homes.
- That would allow people without symptoms to know if they have it before they visit work, grocery stories, and family.
- Eleven companies are bringing these kinds of tests to the forefront, though many are still seeking regulatory authorization from the US Food and Drug Administration.
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Since the pandemic first hit, the US has struggled to ramp up enough testing for the novel coronavirus.
In the months since, companies have been racing to get testing to be cheap, available, and accessible enough to stem ongoing outbreaks. It's got people wishing for something that's cheap, fast, and easy to do at home to get the peace of mind that their chances of spreading the virus are much lower.
"What we all want is the accuracy of the lab in the palm of our hand," Rahul Dhanda, the CEO of Sherlock Biosciences, told Business Insider.
The Boston-based biotech and a handful of other companies identified by Business Insider are making a portable test for coronavirus that can be used at home. Others are selling tests through clinics, pharmacies, and doctors' offices that diagnose people in minutes, without the use of fancy equipment.
The hope is that frequent testing of asymptomatic people can stop outbreaks before they occur and help people make decisions about how to shop, visit family, and work without putting others at risk.
Dr. Michael Mina, a prominent epidemiology professor at Harvard, has advocated for more democratized screening, where people take the coronavirus equivalent to pregnancy tests on a near-daily basis. He's said it's our best bet to stem outbreaks in lieu of a vaccine.
Other experts say it's more helpful for the riskiest work places, like factories and cruise lines.
The best example, according to Dr. Jay Wohlgemuth, Quest Diagnostic's chief medical officer, is nursing homes. Assuming folks aren't coming into the facility if they have symptoms, positive results can be used to send people home and get a confirmatory test, he said. Negative results, on the other hand, can act as a kind of clearance.
To be sure, rapid testing can present its own challenges, as the recent White House outbreak recently showed the world. It's less accurate than than testing by lab equipment to spot the virus in samples. And it's not a one-way ticket back to normal.
"One negative test — from any of the different test types — one negative test isn't a free pass to do anything. That's a point in time measurement," Dr. Brian Caveney, LabCorp's chief medical officer, told Business Insider.
He continued: "That's part of the challenge of this. We need a good longterm strategy altogether for serially testing overtime, and that ultimately is going to be the best way to identify the virus in the community and then appropriately isolate people so that we can contain and minimize the spread as much as possible."
Here are the 11 companies bringing home or rapid testing to the forefront, according to investors, the National Institutes of Health, testing executives, and Business Insider's reporting. They're listed in order of when their tests should get regulatory clearance, according to company estimates.
Abbott Laboratories' test is shaped like a credit card, costs $5, and gives results in 15 minutes. It's only authorized to work in healthcare settings like clinics and pharmacies.
Abbott's quick test is the size of a credit card and costs $5. Authorized in August, it pairs with an app and spots coronavirus antigens from nasal swabs.
Given the $191.87 billion company's manufacturing muscle — Abbott says it can make 50 million of the card-like kits this month — the test has been called a "game changer" by the likes of analysts, HHS officials, and governors.
Abbott declined to say if it was trying to get the tests approved for home use, but President Donald Trump's administration purchased 150 million of them for schools, state governments, and nursing homes, the White House said in August.
Quest Diagnostics is developing speedier tests, one of which is slated for personal use and won't require a doctor's supervision.
Quest, a $15.76 billion lab giant, runs about 200,000 molecular tests for coronavirus every day, which is about 20% of the current US capacity, according to data compiled by Johns Hopkins.
It largely got to that number, up from just thousands of daily tests in March, by adding labs, "pool testing," which groups four samples into a single tube, and drive thru systems with Walmart, Quest's Wohlgemuth told Business Insider.
But now that supply is largely meeting demand from hospitals, Quest is developing new kinds of speedier tests for people that don't necessarily have coronavirus symptoms, he said. Called "antigen" tests, they look for antigens, or viral proteins, typically in minutes and without lab equipment.
"The real value of antigen is going to be in screening and surveillance," Wohlgemuth said. The best examples are factory operators and nursing homes who need to identify people with the virus on a constant basis, he said.
"We don't really have the tool right now to do that. And I think antigen will help. But here's the thing. You can't just then say 'Now that I have antigen I'll just take off my mask and bear hug everyone I see,'" he said.
The company is waiting on the FDA's go-ahead for a rapid antigen test for healthcare settings and intends to apply for more approval for at home use of the same technology, per Wohlgemuth; it's likely that the former will go live in October; and the latter, November.
E25 Bio has a handheld coronavirus test that marks positive and negative results with lines, just like a pregnancy test, and costs $10.
E25 is expecting FDA authorization "soon" for its coronavirus test, which uses a pair of designer antibodies combined with tiny particles to stick to viral antigens on a strip of paper inside a plastic cassette. If a person's infected, a line shows up after 15 minutes.
It's slated for healthcare settings, but the company wants to sell these kits directly to consumers for less than $10, a spokesperson told Business Insider.
E25 spun out of MIT in 2018 and makes tests for infectious diseases. In March, it won $2 million from Khosla Ventures to back its coronavirus work.
Ubiquitome is making speedy kits for healthcare settings that work with mobile apps.
Ubiquitome, a New Zealand-based genetics company, won NIH funding announced this month for its handheld, battery-powered coronavirus test. It's designed for the "field" — airports, schools, workplaces — but will first be used in hospitals and mobile labs, CEO Paul Pickering told Business Insider.
It works with PCR technology that spots viral RNA in saliva, nasal, or other samples within 40 minutes, according to the company. Healthcare workers take the samples and insert them into a tiny box, then results are reported on an app.
It's already being distributed in Asia by Swiss giant DKSH, but the test is still awaiting the FDA's go-ahead in the US. Pickering is expecting the EUA in the next few months, he said.
Scanwell Health has a test underway that spots coronavirus antibodies. With a telemedicine group, they'll ship kits to people and supervise their tests over video.
Scanwell's been working on its test since March. After submitting an application for an emergency use authorization, the FDA's temporary mark of approval, and running two clinical studies, one with Wake Forest Baptist Health, the FDA recently asked the company for more data, according to Jack Jeng, Scanwell's chief medical officer.
They're now hoping for authorization by the end of 2020, he told Business Insider. Once available, Lemonaid Health, a telehealth company, will sell the tests on its website and app, plus supervise people's tests through online doctors' appointments.
Scanwell is a two-year-old startup based in Los Angeles that makes home tests for UTIs and kidney damage. Its coronavirus kits require finger pricks of blood and look for antibodies, which our immune system makes to fight off invaders like coronavirus. If present, they bind to antigens and get captured on a tiny membrane, generating a purple line for users, Jeng said.
The whole process takes 15 minutes, but Lemonaid's healthcare people will also circle back to discuss the results, Jeng said; before insurance, Scanwell is expecting to sell the kits for $30.
Read more: A buzzy startup's struggle to make the first at-home test that can tell if you've had the coronavirus reveals a crucial roadblock to reopening the US
Mammoth Biosciences is working a personal coronavirus test that uses CRISPR enzymes to spot the virus from nasal swabs. It's meant to work in 30 minutes.
Mammoth, a biotech started 2017 by a group of founders in their twenties, is making a coronavirus test that's handheld, disposable, and doesn't require any big equipment.
Developed in part with GSK, it'll work with CRISPR technology that targets the coronavirus genome according to a guide, Janice Chen, Mammoth's chief technology officer, told Business Insider. People will take nasal swabs, insert them into a device, and then check back 30 minutes later for the result.
"So this has been a promise in diagnostics for a long time and up until now, people haven't quite been able to deliver on it," Chen said, referring to fully at-home testing.
She added: "There are a lot of reasons why, and it's a very, very tough problem, but now we have a new kid on the block, which is CRISPR."
The company received NIH funding and an emergency use authorization, the FDA's temporary mark of approval, for another coronavirus test that uses labs, but the founders hope to demonstrate the same technology can work in a handheld device.
That'll require at least one further round with the FDA, though Mammoth is aiming to make the device available to folks by the end of the year, Chen said.
Read more: Meet the 30 young leaders who are forging a new future for the $3.6 trillion healthcare industry
Sherlock Biosciences has two kinds of tests in the works. One's made for home use and could be approved in early 2021.
Sherlock is developing a portable test for coronavirus where synthetic genes activate when combined with the virus, resulting in peptides that can be detected on "lateral flow strips," or plastic kits like pregnancy tests.
The Cambridge-based biotech startup was founded last year by eight Harvard and MIT inventors, professors, and scientists, plus its CEO Rahul Dhanda, who joined after more than a decade in the pharma and diagnostics industry.
Sherlock won the FDA's go-ahead for the first-ever CRISPR-based diagnostic test in May. They're making a device with Binx Health, another testing shop, that'll let the tech work real-time in clinics, nursing homes, urgent care facilities, and other healthcare settings, Dhanda said.
The company is expecting an EUA for the at-home test in the first half of 2021, he told Business Insider.
Mesa Biotech is pumping out tens of thousands of tiny molecular tests per week. For now, only healthcare workers can administer them, but home tests are on the way.
Mesa, a testing company based in San Diego, is making 50,000 tests per week with NIH funds and aims to more than double that by the first quarter of 2021, according to CEO Ingo Chakravarty.
The FDA-authorized kit involves a handheld PCR device, which is basically a small box, and disposable cartridge for samples. If present, coronavirus DNA gets amplified inside the box and combines with a probe that triggers a positive or negative result in 30 minutes.
Chakravarty wants to make the test available to consumers and plans to submit the appropriate paperwork to the FDA by the end of the month. For now, it's being used by employers, schools, and sports teams, as long as healthcare people work the machine, according to Mesa.
Ellume wants to sell its over-the-counter coronavirus test on Amazon. It works with nasal swabs and should be priced under $30, once available.
Ellume wants to sell its coronavirus test through Amazon and over-the-counter at pharmacies and drugstores, CEO Dr. Sean Parsons told Business Insider. The Queensland, Australia-based startup makes tests that use antigen technology with a "fluorescent immunoassay platform" that spots light emitted by virus particles.
The NIH-backed effort includes a few tests, one of which is just for consumers. It comes with nasal swabs, instructions, and an app that shows people how to use the test. After 15 minutes, it reports the results over Bluetooth to smartphones.
Parsons also sees the tech helping stadiums and airports do away with on-site testing in favor of shipping people the test before they arrive in the first place. Other Ellume tests, one antibody and one antigen, are slated for clinics and doctors' offices.
Parsons, who worked on the frontlines of the 2009 H1N1 pandemic, wants to price the home test at $30 or less. But US sales are pending EUA authorization, which the company will apply for in the next few weeks, he said.
DetectaChem is trying to figure out how to make its coronavirus test available at home, but the process uses heating that can't easily be done without expensive machines.
DetectaChem has funds from the NIH to scale up production of rapid tests for healthcare settings, COO Travis Kisner told Business Insider. Outside of the pandemic, the company does a lot of work with the military and police to test for drugs and explosives.
The coronavirus test is similar to a PCR, using primers, reactionary dyes, and pH chips in a process called "isothermal amplification" to spot viral genes. It takes about 18 minutes, and the end result is a yellow mark for positive or red mark for negative, he said.
Ultimately, the company wants to make fully at-home tests, but they likely wouldn't be authorized for several more months, according to Kisner. The complex testing method requires heating that's not easy without expensive machines.
3M and MIT are making a paper-based coronavirus test that spots viral antigens.
A $95.98 billion device maker, 3M is working with Massachusetts Institute of Technology researchers on a rapid, paper-based test.
The company declined to give details about the test and approval process, but it'll work by finding antigens in samples collected in traditional healthcare settings, per a July announcement.
The project won $500,000 from the NIH, the announcement said, and the organizations said they can make millions of kits per day.
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