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LetsGetChecked At-Home Molecular SARS-CoV-2 Test Nabs FDA Emergency Use Authorization

NEW YORK – Home health testing company LetsGetChecked announced Friday its Coronavirus Sure-track Test for at-home use received Emergency Use Authorization from the US Food and Drug Administration.

The test is intended for nasal swab specimens self-collected by people at home who have been determined by a healthcare provider to be at risk of being infected with SARS-CoV-2 and prescribed the kit. PrivaPath Labs, a CLIA-certified lab which does business as LetsGetChecked, will perform the RT-PCR testing with results provided within 24 hours. 

According to an FDA document, PrivaPath will use Hologic's Panther Fusion SARS-CoV-2 assay, which received EUA in March, as well as an RNaseP gene RT-PCR test run for each sample to test for the presence of the RNaseP gene to determine appropriate sample collection.

After swab collection, the sample is placed in a solution that deactivates the virus, which LetsGetChecked said ensures shipping providers and lab technicians are protected from infection. The test is available on the company's website for $129 per kit for patients who meet the criteria on a COVID-19 guided risk questionnaire.

The Sure-track Test is the only EUA at-home test that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis, and physician approval, the company said in a statement. Patients who test positive can access telehealth services and guidance on next steps from LetsGetChecked's online platform, it added.

LetsGetChecked's lab in Monrovia, California, is currently at a capacity of 300,000 units per week and building towards providing "millions per week" in the future, the company said. Earlier this month, the company closed a $71 million Series C financing round, which it said would help increase manufacturing, supply, and testing capacity for SARS-CoV-2.

The Dublin-based firm rolled out a two-part test for SARS-CoV-2 in March that includes an initial point-of-care lateral flow assay and confirmatory real-time PCR test in its laboratories.