Conn. entrepreneur seeks emergency authorization for DIY COVID-19 test
The at-home test that yields results in under an hour was trialed by firefighters who called it "a great resource"
New Haven Register, Conn.
GUILFORD, Conn. — An at-home COVID-19 test that is as accurate as laboratory-performed PCR tests and yields results in under an hour may be on the horizon.
The test, known as Detect, is the brainchild of Dr. Jonathan Rothberg, a Guilford-based entrepreneur known for pioneering a rapid DNA sequencing method that won him the National Medal of Technology and Innovation from Barack Obama.
To take the test, which Rothberg expects will cost between $25 and $35 at its first distribution, a nose swab is taken from the lower nostril, and the sample is put in a vial whose cap contains the reagents necessary to detect COVID-19's genetic fingerprint, according to Rothberg, who demonstrated the steps Monday via Zoom.
The vial is then heated in a reusable bay station and inserted into a reader that Rothberg said has three separate indicators: one line confirms whether human DNA was collected, one indicates whether COVID was detected and the last says whether the reader is working.
Detect has not yet received emergency authorization from the Food and Drug Administration but is currently undergoing trials, Rothberg said.
If all goes well, those trials will yield point-of-care emergency authorization, the entrepreneur continued, meaning the test could be used by individuals with proper training, such as school nurses and nursing home staff.
An FDA spokesman said Monday the agency does not comment on pending applications.
"My dream was to get a test approval before the end of the year, but as you know these are big processes," Rothberg said "We're confident in our test, and now we have to share that confidence with the FDA."
Though his team is initially seeking emergency authorization and would first provide the tests to healthcare professionals, Rothberg's ultimate goal is to make the test available to general consumers, he said.
He decided to pursue the project in early March, when he shared the idea on Twitter.
"I told the team that they had to come up with a test that didn't require a $25,000 machine ... and that they had to take all the complexity from the clinical lab and put it in a little tablet," he said. "They were able to pull that off."
In addition to providing at-home results in about 45 minutes, Rothberg said, the Detect test is meant to be as accurate as the "gold standard" of COVID-19 testing.
That standard typically entails a PCR test, which detects the virus' genetic fingerprint. But since samples must be processed in a laboratory, for patients who manage to get the test it usually takes at least a day, if not several, to learn the results.
The other main type of test on the market, known as an antigen test, can deliver results in minutes and is cheaper — it typically costs around $15 as compared to the PCR test's $130, per Rothberg — but its accuracy is also questionable.
False negative rates as high as 50 percent have been reported for antigen tests, according to a blog post from Havard Medical School last updated Sept. 30.
(The post also says the reported false negative rate for PCR tests has ranged from 2 percent to 37 percent. A report in the British Medical Journal, which the Harvard site links to, puts that range at between 2 and 29 percent.)
"While we never make claims about our own test, we make claims about our approach, and our approach is to be the most sensitive and the most specific," Rothberg said. "What we're doing is moving to the point of care, and to the home, that gold standard and PCR-like test."
As it awaits FDA approval, Detect has already been put to use locally: at a tent set up in Guilford, staff have already performed over 1500 tests on volunteers, according to Rothberg, who said those volunteers give his team feedback on how to make the kit more user-friendly.
Guilford firefighters were among the tent's visitors, per Assistant Chief Michael Shove, who described the set-up as "a great resource."
While Sonia Marino, the town's health director, said she was not very familiar with the project, she indicated she was aware of several people who had taken advantage of the Detect test.
Detect has already proven useful to Rothberg's family, as the entrepreneur said his son's roommate used the test a little over a month ago.
The roommate was positive for COVID-19, according to Rothberg, who added the result was confirmed via a laboratory test and that early detection prevented his son from getting sick.
Rothberg isn't waiting for FDA authorization to manufacture the testing kits, either — he aims to have stacks of them ready for distribution as soon as it comes through, he said, adding that his team has the capacity to manufacture 1 million tests per month but will ultimately ramp it up to at least 10 million.
According to Rothberg, some of his other companies have been involved in the fight against COVID-19, including the Butterfly Network, known for its portable ultrasound device. The entrepreneur said the scanner has been used to detect COVID's impact on the lungs.
Butterfly recently went public, merging with Longview Acquisition Corp in a deal expected to provide over $580 million in cash, according to a release. Rothberg said the merger was meant to provide capital that will be used to strengthen the impact of the device,
The entrepreneur's vision goes beyond even the current pandemic.
Down the line, the reagents used in the Detect test could be switched out for molecules that detect other pathogens, like the flu, according to Rothberg.
"We've really made a platform, not just the COVID Detect test," he said.
If a gene were found to be associated with susceptibility to COVID-19 and other illnesses, Rothberg said, the Detect test could be adapted to detect that, too.
(c)2020 the New Haven Register (New Haven, Conn.)