LetsGetChecked to release the first two-part test for coronavirus (COVID-19), allowing patients, under the care of healthcare professionals, to receive immediate indication for the presence or absence of infection, while more complete laboratory tests are conducted for definitive confirmation.
Test will be available on March 30, 2020, initially in the U.S. only, with healthcare workers on the frontline prioritized
Comprehensive two-part test gives immediate results about active infection using a point-of-care (POC) device to be administered by healthcare professionals and a secondary lab-based confirmation available 1-2 days later
LetsGetChecked invested millions of dollars to set up a new U.S. based CLIA certified-high complexity lab, which allows the company to rapidly scale up testing capacity
The company has committed to 250,000 tests in the first batch, with the goal to scale to serve over 1 million of the most at risk patients within the next several months
LetsGetChecked has taken action to relieve pressure on overstretched hospitals and speed up identification of cases to prevent the spread of coronavirus, which causes COVID-19
LetsGetChecked is working with individual laboratory partners to deliver across other European markets as quickly as possible
LetsGetChecked are announcing a new two-part test for coronavirus (COVID-19), to help U.S. healthcare workers on the frontline battle the pandemic.
The LetsGetChecked Coronavirus Test (COVID-19) is the first test 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 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 minimizing the exposure to critical care facilities.
The company has committed to 250,000 tests in the first batch, with the view to scale to over 1 million tests within the next few months.
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 are prioritizing their first line of testing services to those working within the healthcare system and at-risk groups. This will be made available through payer and provider channels starting on March 30, 2020.
The test is designed to be administered by healthcare professionals in patients’ homes and other locations where testing is required. 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.
The company is working with the FDA to have an emergency use application (EUA) approved for use by customers to test in the home. Unlike the healthcare professional kits, the direct-to-consumer kit will only contain the laboratory test using the nasal and throat swabs. It will be available to consumers in the home through LetsGetChecked.com, but will be limited to one test per order. However, until approved by the FDA for direct-to-consumer testing, the kit will not be available for purchase online.
This test will initially only be available in the U.S., where LetsGetChecked has invested millions of dollars in setting up a CLIA certified laboratory, which allows the company to improve access to coronavirus testing. The company is currently working with individual laboratory partners to expand the availability of the coronavirus screening tests to other European countries significantly affected and aims to to start offering testing by mid-April. As with the U.S., tests will be prioritized for frontline healthcare staff and at-risk groups.
To maximize the accessibility to testing, LetsGetChecked is pricing the test at the true cost of $129 per unit. For transparency, costs 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.
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 LetsGetChecked laboratory (return prepaid shipping labels included). Our CLIA certified lab then analyzes the sample using the gold standard 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 one-on-one consultation. Positive COVID-19 results are reported in accordance with local, state, and federal regulations.
Peter Foley, CEO and Founder of LetsGetChecked said: “We set up this company to help people by providing diagnostics and medical 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 in this global pandemic. We are in a unique position to act quickly and help people get the testing they need."
“There is currently a severe lack of testing capacity in U.S. laboratories for the coronavirus. Our investment in a high complexity CLIA certified laboratory with scalable testing platforms, will allow a greater volume of tests to be screened per day, speeding up identification of potential cases and contributing to the understanding of what levels of the virus exist within the population.”
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. The introduction of at-home testing will 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."
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