Australian company first to develop fully at-home COVID test
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Earlier this week, the FDA gave emergency authorization to the first at-home coronavirus test kit that doesn’t involve a prescription and returns a result within 15 minutes, without having to be sent off to a lab for analysis.
It’s a technology 10 years in the making, with 96% accuracy in clinical trials, and it’s developed by Australian company Ellume.
The regulatory approval comes as the pandemic continues to rage in the U.S. The latest figures showed more than 3,700 deaths and more than 250,000 new cases recorded in a single day after a sustained spike in infections over the last month. What’s more, health officials are concerned Christmas and New Year’s celebrations will make the situation worse.
At-home test kits from Ellume are expected to begin hitting pharmacy shelves beginning in February.
On the global edition of the “Marketplace Morning Report,” founder and chief executive Dr. Sean Parsons told the BBC’s Victoria Craig what makes his kit different from others on the market.
Below is an edited version of their conversation.
Parsons: I founded the company in 2010, after the swine flu pandemic, and we set out to create high-performance diagnostics to enable the detection of common infectious diseases like flu, especially focused on the ones that could cause pandemics. And so when the COVID pandemic struck, we were a long way down the road at having created this core technology, refined it in making a home flu test over many years. We’d used the core technology in other areas, including big partnerships with companies like Qiagen and GlaxoSmithKline. The technology was well advanced, which meant that we could move quite swiftly to create the home COVID test. What makes us different is that all of the analysis happens in this single-use analyzer, which is really the brains of the test. It’s got all of the biologicals and the asset components, as well as the electronics and optics in order to be able to interpret that result, and then it communicates that result to your phone. What’s neat is that we be able to miniaturize this, make it high performance yet affordable and compatible with an over-the-counter product.
Craig: How does the kit itself work? If I were to pick it up off the shelf and bring it home, what happens next?
Parsons: Everything that is required to perform the test is inside the box, with the exception of your personal smartphone, which you will need to use to be able to get a result from the test. The way the test works is you download a free app. The app has in it a short video, which explains how to use the test. And then step-by-step instructions, which will walk the user through the use of the test. It’s really simple. We’ve run a whole bunch of studies to be able to prove to the FDA that people can use it correctly. And it takes about five minutes to collect the sample and apply it to the test, and then about 15 minutes to obtain the final result.
Craig: PCR tests, I think, are widely seen sort of as the gold standard for these COVID-19 tests. How is yours different?
How does this test work?
Parsons: The molecular tests are terrific. They’re very, very high performance. They are, for the most part, relatively slow and relatively expensive and limited to the central laboratory settings with trained people to use them. There are a few exceptions to that where there are molecular tests at the point of care, but they’re very much the exception rather than the rule.
Our test is what’s called a fluorescent immunoassay. So we use a quantum dot nanoparticle, which we developed in conjunction with our friends at Thermo Fisher to create an ultra-bright fluorescent reporter to detect proteins of coronavirus. So ours is an antigen test which uses next-generation immunoassay technology to get improved performance on the existing immunoassay products that are in the market.
So this uses next-generation technology to get improved performance on the existing products that are in the market. That gets us pretty close to PCR, but not quite the same performance. In the clinical trial, we had 96% overall accuracy. So we’re quite close. But there are still advantages of those molecular products. Our view is that there is no single test which will which will be a silver bullet here. And that all tests have their strengths and their limitations. We see it as just part of the puzzle.
How much will the test cost and when will it be available?
Craig: So it’ll be about $30 for people in the U.S. and it won’t require a prescription. How quickly do you think you can get it onto shelves?
Parsons: We hope to have it on shelves in February. Obviously the retail opportunity is an important one, where people can buy it from a major pharmacy chain like CVS or Walgreens. Or ultimately we’d love to see the product in the U.K. in a Boots or a Lloyds. But there are other places where we believe we can do important benefit, particularly in terms of large employers. The hospital situation, in particular, where staff are essentially constantly exposed to COVID and being able to screen hospital health care workers is an important mechanism of trying to reduce the transmission of COVID. And lastly, there are uses of the product in China to enable important sporting events and other cultural events where people are in close proximity.
Craig: And to do that you’ve already started ramping up manufacturing capacity there in Australia. So when it comes to other parts of the world, are you working with other governments to approve these test kits in other countries?
Parsons: The primary focus has been the U.S. to date. We will be looking to go further afield internationally through 2021. However, on the back of the support from the National Institutes of Health RADx program, who gave us a $30 million grant earlier this year, we’re very focused on manufacturing our product and bringing it to the U.S. as quickly as we can. Those other countries, European countries in particular, are certainly places where we’d like to see the test deployed. But, for the time being, we think America will be able to soak up all of the products which we can produce.
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