NEW YORK – At-home testing company LetsGetChecked recently rolled out a new, two-part test for SARS-CoV-2 and has announced its eagerness to partner with healthcare authorities in the US and Europe to bring its offering to the frontlines of the coronavirus pandemic.
The company's approach relies on an initial point-of-care lateral flow assay followed by a confirmatory real-time PCR analysis run in its laboratories. CEO and Founder Peter Foley said that the company's point-of-care testing approach could help reduce the spread of the disease, both by aiding in early diagnosis as well as reducing the burden on healthcare systems.
"The use case is that people should be testing at home, instead of going to clinics at a time when resources are tight and it's important to reduce contagion and we are telling people to self-quarantine," Foley said. "The ideal scenario from a diagnostics standpoint is being able to do it in the home."
Foley founded LetsGetChecked in 2015 with the aim of enabling people to obtain information about themselves through home diagnostics. Since then, the firm, which is based in Dublin and New York, has rolled out a menu of lifestyle, cancer screening, sexual health, and fertility and hormone tests, grown to about 160 employees, and built a CLIA-compliant laboratory in California. LetsGetChecked relies on multiple laboratory partners to carry out testing in Europe.
The firm also manufactures its own lateral flow assays, and Foley said the firm is positioned to address the kinds of constraints that are currently facing test makers. "From the very outset, we decided to take on the supply chain," noted Foley. "We have full control over everything, from the kit manufacturing side to having ISO 13485-accredited facilities in Europe and the US."
The company, which has raised $42 million over the past two years, had been focused in recent months on marketing its growing menu of tests, but refocused over the past month because of the pandemic. "When this COVID-19 issue broke, we pretty much just dropped everything and focused 100 percent on this, getting the various elements in the supply chain right, and then on being able to get these tests into the hands of the people who need them the most," said Foley.
The company devised a two-part test that involved a point-of-care, serological assay that can detect the presence or absence of SARS-CoV-2 antibodies within 15 minutes. The company says this will give users an indication as to whether or not they might have contracted the virus and should self-quarantine.
The second part of the test relies on a nasopharyngeal swab which is mailed to one of the company's labs for analysis via real-time PCR. For an actual diagnosis, getting confirmation via the lab-based real-time PCR test is important because serology tests may not be sensitive enough for diagnostic use, especially during early onset of disease.
As the company relies on multiple labs to deliver results, the platform is at the discretion of the lab. Foley said the firm's labs are using platforms that have received Emergency Use Authorization from the US Food and Drug Administration for coronavirus testing, such as those sold by Roche, Thermo Fisher Scientific, and several others.
The company has priced its assay at $129 per unit, which it says is the cost of the assay. The price covers testing, express return shipping, lab analysis, physician review, nursing support, and access to an IOS mobile application so users can access their results online.
The test is being made available to healthcare professionals initially, with the initial point-of-care assay being used to determine potential infection and need to self-isolate while awaiting confirmation. The company is reaching out to payors and providers to make the test available to frontline healthcare workers first.
"From the get-go, we realized that in a world that's got finite resources we just wanted to get what we developed to frontline healthcare workers, frontline workers, and those most vulnerable," said Foley of the approach.
LetsGetChecked has also submitted an application to the US FDA for EUA to enable the firm to offer its test directly to consumers, but does not have a specific timeline for approval, Foley said.
For its part, the FDA is wary of at-home based tests for SARS-CoV-2 tests and issued a consumer alert last month that it would go after players it believes is running afoul of regulations.
As for serology-based testing for the coronavirus, the agency issued its first Emergency Use Authorization to such a test only on Thursday to Cellex.
LetsGetChecked's direct-to-consumer kit will consist of only the nasal and throat swabs for mail in for real-time PCR analysis, not the lateral flow assay. The company will not begin offering its test before receiving the go-ahead from the FDA.
The company is, in the meantime, also working with its laboratory partners in Ireland and the UK to enable the roll-out of its test in those countries. Last week, the company also issued a statement offering its support to the Irish government, noting it had sent letters last month addressed to the Irish Health Minister and Health Service Executive underscoring LetsGetChecked's willingness to assist the government. The company is hoping to begin a dialogue with the state that could see its tests adopted for use by state healthcare professionals.
"We need to make sure we are getting these tests to those who are in most need," said Foley. "We are here to help."
According to the World Health Organization's April 3 COVID-19 Situation Report, there have been about 4,000 cases of SARS-CoV-2 in Ireland to date and nearly 100 deaths.
LetsGetChecked has already committed to manufacturing 250,000 kits to begin with. In the meantime, it is scaling up its efforts. "It's in our wheelhouse, but we just had to scale up faster and bring in equipment, machinery, and assays on the lab side to cater to this higher volume," said Foley. "It's two ends of the stick really, where we need to scale and where we are scaling to."
It's an issue that is facing manufacturers across the board as they struggle to increase kit manufacturing. "The problem is consistent everywhere in terms of the growth rate and shortage of testing," noted Foley. "The problem is a global shortage of testing and within the diagnostic space, things like kits, reagents, everything that's required, there is a common thread," he said. "Unfortunately, the market is playing catch up."