World's First Two-stage Coronavirus (COVID-19) Test Is Available to US Frontline Workers Now

NEW YORK, April 9, 2020 /PRNewswire/ -- The world's first two-stage coronavirus (COVID-19) testing kit is now in use nationwide, bringing testing to the most at-risk in the population.

In a bid to support healthcare professionals to administer much needed testing to frontline workers, global at-home health testing and insights company, LetsGetChecked, began production of their own Coronavirus (COVID-19) testing kits in early March. The tests, which are available now to frontline healthcare workers in the United States, are being manufactured at LetsGetChecked's state-of-the-art production facility in Dublin, Ireland, where staff have been working around the clock. The company aims to scale up production to 100,000 tests a day by the end of April.

Over the last five years, LetsGetChecked has developed an end-to-end infrastructure that supports in-home testing for a variety of important clinical indications. Now, during this critical period, the platform is being leveraged to provide crucial testing to healthcare and frontline workers integral to the fight against the global pandemic.

The test is broken down into two parts: a rapid test which gives results within 15 minutes, followed by an oral and nasal swab which will be analyzed in LetsGetChecked's high-complexity CLIA laboratory. It is designed to be administered by healthcare professionals in patients' homes and other locations where testing is required. This to ensure proper sampling for accurate results.

The kits will help speed up identification of potential cases and 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 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.

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 company is also working on an Emergency Use Authorization (EUA) with the FDA, which would see people test themselves in the home. Unlike the healthcare professional kits, the kit will only contain the laboratory test using the nasal and throat swabs. Tests will be made available through health plans and provider groups, who can help identify those most at risk and in need of testing.

When approved, the home-testing kit will initially be available only in the U.S., where LetsGetChecked has made significant investment in setting up a high-complexity CLIA certified laboratory, allowing the company to test many thousands of samples a day.

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: "I don't mind saying there was a lump in my throat seeing the first 10,000 kits roll off the production line. Seeing the tests being boxed-up and put on pallets in the back of UPS trucks ready for distribution to what is now the global epicenter of the pandemic, was incredibly emotional. Knowing that these tests will save lives and that we are producing tens of thousands each day, gives me hope that we will win this battle.

"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. I am absolutely committed to diverting all resources to this fight, so that we can be part of the solution."

"With a severe lack of testing capacity in U.S. laboratories, we have turned over our high complexity CLIA certified laboratory to screen thousands of samples per day This is critical to improving our 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."

Notes to Editors

• High Resolution images of the LetsGetChecked Coronavirus (COVID-19) Tests rolling off the production line and being placed onto UPS delivery trucks are available HERE
• High resolution videography and B-Roll of the LetsGetChecked Coronavirus (COVID-19) Test production and distribution facility available HERE

NB: Image and videography credit: 'LetsGetChecked'

About LetsGetChecked

LetsGetChecked is a leading health insights company that allows consumers direct access to a wide range of testing options and clinical services from home. Founded in 2015, the company empowers people to take an active role in their health to live longer, happier lives. By combining health data and diagnostic results, LetsGetChecked provides rich health insights to enable better healthcare decision making. LetsGetChecked tests cover general health, men's health, women's health, and sexual health, and are available nationwide in the US, Canada, and Europe. LetsGetChecked has corporate offices located in New York City and Dublin. For more information, visit www.letsgetchecked.com.

SOURCE LetsGetChecked

Related Links

https://www.letsgetchecked.com/us/en/

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