New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.

According to the company, Sure-track is the only EUA-backed at-home COVID-19 test that owns all aspects of the testing service – from manufacturing the collection kits to logistics, lab analysis and physician approval of testing eligibility.

Letsgetchecked’s CLIA/CAP/BSL II-certified, high-complexity lab in Monrovia, Calif., currently has capacity for 300,000 units a week, with plans to ramp up to millions per week to meet anticipated demand across the U.S.

“With the FDA EUA authorization, we are thrilled to introduce the Sure-track Test to offer convenient, secure and highly accurate at-home testing for coronavirus to communities in need in the United States,” said Peter Foley, Letsgetchecked’s founder and CEO. “We’ve spent years building the only true end-to-end service on the market, which allows us to deliver unparalleled service to our customers.”

Consumers prescreened for need

Before receiving the test, consumers must complete a questionnaire to determine if testing is warranted. The assessment includes questions about gender, age, the presence and severity of symptoms, preexisting health conditions and risk of exposure – all in line with current CDC guidelines, the company said.

Once received, customers self-swab and place the sample in a transport tube to be sent to the lab for processing. The tube contains a solution that deactivates the virus, preventing shippers and lab technicians from possible infection. The nonsaline solution also protects the integrity of the SARS-CoV-2 RNA, increasing its accuracy, the company said.

Results are available within 24 hours, and users have access to 24/7 telehealth services via Letsgetchecked’s connected platform. The cost per kit is $129.

“Our entire system was considered as part of the review process, and we are delighted to have worked with the FDA to delivery a truly unique at-home coronavirus testing service to customers,” said Gwen Murphy, director of epidemiology and clinical studied at Letsgetchecked.

Two-track strategy

The Sure-track PCR test is the second in a two-track strategy for COVID-19 testing. In March, the company released a 15-minute rapid serology test, allowing patients who are under a doctor’s care to get an immediate indication of the presence or absence of infection while more complete laboratory tests are conducted.

Founded in 2014, Letsgetchecked has raised about $114 million from the investors. The last funding round, an oversubscribed series C led by Illumina Ventures and Hlm Venture Partners, tallied $71 million to support the U.S. and EU scaleup for the COVID-19 tests.

In addition to COVID-19, the company’s portfolio includes tests for general health, men’s and women’s health and sexual health. All are available in the U.S., Canada and Europe, with the exception of the coronavirus test, which is currently U.S.-only.

Competition

Other companies are also eyeing the at-home COVID-19 test market. South San Francisco-based Mammoth Biosciences Inc. recently teamed up with Glaxosmithkline plc, of London, to develop a point-of-care test to detect active COVID-19 using the former’s CRISPR-based DETECTR (DNA endonuclease-targeted CRISPR trans reporter) platform. The two companies hope to submit file for an EUA before the end of the year, with the ultimate goal of an at-home test.

Another contender is Scanwell Health, which last week announced exclusive rights to an at-home rapid serology test for SARS-CoV-2 made by China-based Innovita Biological Technology Co. Ltd. Scanwell aims to make the test available in the U.S. within six to eight weeks of gaining an EUA thumbs up from the FDA.

Meanwhile, Kahala Biosciences LLC and Rymedi Inc. have launched Adiona, a COVID-19 antibody testing platform that includes a blockchain-enabled smartphone app to improve predictability and traceability of disease outbreaks. The fingerprick test is currently conducted at a health care facility, but Kahala CEO Francis Duhay told BioWorld the “vision is for people to employ both viral antigen and antibody testing at home.”

With the number of COVID-19-related tests continuing to grow, the FDA is encouraging developers to file 510(k) applications once they have enough data to support a submission.

“We encourage these applications as soon as the developers are ready, and we’re willing to work with them right now” on converting EUA test dossiers into conventional premarket filings,” Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said during the agency’s May 27 town hall meeting. He noted the FDA has some discretion to keep EUA tests on the market despite a 510(k) filing for a certain type of test, so it is unlikely the need for EUA tests will evaporate anytime soon.

Letsgetchecked said it is considering a 510(k) for its COVID-19 testing service.

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