Dublin headquartered, LetsGetChecked, a global leader in the direct-to-consumer at-home health testing market, has written to Health Minister Simon Harris TD and the HSE, to offer support, as the country attempts to meet the challenge of mass testing for the coronavirus.
LetsGetChecked has developed a unique two-part test for coronavirus designed to offer the most accurate results possible, as countries struggle to meet the surge in demand for accurate testing kits.
Alongside the new two-part test, the company is uniquely placed through its existing end-to-end infrastructure and logistics network to support in-home testing for coronavirus in a way that nobody else can.
Peter Foley, CEO and Founder of LetsGetChecked said: “We set up this company to help people by providing health screening and care in the home. We have been developing our platform for years around this core concept and have delivered hundreds of thousands of tests to patients remotely. We are committed to diverting all resources to this problem so that we can be part of the solution to help people fight this global pandemic.
“We are in a unique position to act quickly and help our frontline health workers get tested safely. We hope to be able to do this as soon as possible and have written to the Health Minister and the HSE to find the quickest practical solution.
Foley said: “We all, LetsGetChecked included, have a responsibility to help wherever we can during this national crisis and we are well placed I believe, to be able to offer considerable support, should the Government require it.”
Foley continued: “We made a significant investment in setting up our own high complexity CLIA certified laboratory in the United States last year. This lab allows us to screen an incredible volume of tests each day, speeding up identification of potential cases and contributing to the understanding of what levels of the virus exist within the population. We want – desperately – to be able to do the same for our own citizens during this national emergency.”
It is hoped that the Government will engage with LetsGetChecked and allow it to start distributing testing kits to frontline healthcare providers, key workers and those that need it most.
The test itself is the first to offer immediate point-of-care (POC) results, followed by full laboratory analysis using both an oral and nasal swab sample.
The tests will not only help relieve pressure on over-stretched hospital screening services and speed up the identification of potential cases, but will also protect vulnerable populations by allowing them to be tested in the home or elsewhere by healthcare professionals, thereby minimising the exposure to critical care facilities.
Over the last five years, LetsGetChecked has developed an end-to-end infrastructure that supports in-home testing of a variety of important clinical indications. Now, during this critical time, this platform can be leveraged to provide important testing to those in need. While the company has historically sold online and through retail channels direct-to-consumer, they want to prioritise their first line of testing services to those working within the healthcare system and at-risk groups.
The breakdown of the testing process is as follows:
Part 1 is a rapid blood test that identifies an active SARS-CoV-2 infection within 15 minutes of testing using an easy-to-read POC device, similar to a pregnancy test strip. The device detects the presence or absence of SARS-CoV-2 antibodies, proteins the body produces to fight off the viral infection, which develop several days after experiencing symptoms. The test will give individuals an immediate indication as to whether they have contracted the virus and should begin self-quarantine. Individuals will also have access to a resource page available via an iOS app or online via mobile device and desktop and can request a call from a LetsGetChecked nurse to discuss next steps.
Part 2 involves a laboratory-based confirmation test using swab samples collected from both the throat and nasal cavity (step-by-step instructions are provided). Swabs are placed into a sealed transport buffer that kills the virus, but preserves the RNA for transport to the laboratory (return prepaid shipping labels included). The lab then analyses the sample for SARS-CoV-2 virus confirmation testing, Real-Time (RT) PCR.
Together, the two tests offer a unique and comprehensive approach to coronavirus testing.
As with all LetsGetChecked home health tests, support will be provided in the form of online resources, physician review, and access to LetsGetChecked’s dedicated nursing team for a one-on-one consultation. Positive COVID-19 results are reported in accordance with local, state, and federal regulations.
In the United States, the company is already working with the Food and Drug Administration (FDA) to have an emergency use application (EUA) approved for use by customers to test in the home. At launch, the full two-part test, including the POC test will only be available to healthcare professionals to ensure proper sampling for accurate results.
LetsGetChecked invested millions of dollars to set-up a CLIA certified high complexity laboratory in California late last year before the pandemic hit. The lab has enabled the company to improve access to coronavirus testing and hopes to partner with the Irish Government, as well as individual laboratory partners, to expand the availability of the coronavirus screening tests to its own citizens. As with the US, Founder and CEO Peter Foley has said: “Tests will, absolutely, be prioritised for frontline healthcare staff and at-risk groups.
He continued: “If we are able to open a dialogue with the Health Ministry and the Government, then I see no reason why we couldn’t start offering the two-part at-home test to frontline healthcare providers and key workers by mid-April.”
To maximize the accessibility to testing, LetsGetChecked is pricing the test at its true cost per unit. For transparency, this cost will cover testing, express return shipping, lab analysis, physician review, nursing support and access to a LetsGetChecked IOS mobile app so patients can access results online.
Dr Robert Mordkin Chief Medical Officer for LetsGetChecked said: “We are in the midst of a global pandemic, the magnitude of which we are still trying to understand. The best way to contain it is through sensible steps to stop the spread. Beyond that, it’s testing. Test, test, test. The introduction of it-home testing would be a game-changer in the ability to detect the infection and support those healthcare workers on the frontline.
“LetsGetChecked’s tried and tested logistics infrastructure is designed for getting at-home screening kits into the hands of patients and then back into our lab for analysis in the most efficient and safest way possible, but it requires Government support.”