Quest, LetsGetChecked Win EUAs for At-Home COVID-19 Tests

Quest Diagnostics’ self-collection kit for COVID-19 received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on May 28. The self-collection kit lets users self-collect a nasal specimen at home or clinic, when a clinican determines it to be appropriate .
 
Individuals can swab the front part of the nostril and may be used on supervised children and adults. Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack).
 
Specimens may be tested with Quest’s SARS-CoV-2 RT-PCR test, which received an EUA in March. 
 
“COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection,” Steve Rusckowski, Quest Chairman, CEO and president told the press. “The self-collection kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods.”
 
“We plan to utilize this device with a range of populations, from state-run programs and employers to healthcare providers and individuals,” said Jay G. Wohlgemuth, M.D., Quest senior vice president and chief medical officer. “Our scientists at our advanced diagnostics laboratory in San Juan Capistrano, Calif. developed the technology, which has been validated in real-world studies.”
 
Quest shared data with FDA that indicate the self-collection kit offers a consumer-friendly approach to high quality diagnostic testing for COVID-19. Quest already tested specimens using a similar collection method in real-world settings in drive-thru and other onsite COVID-19 testing sites across the U.S.
 
The self-collection kit was developed to be very consumer friendly, with the specimen collected at home and without the need to directly involve a healthcare professional to perform or observe the collection.
 
Key features of the new kit include:
 

• Self-collection by individuals, at home, with a consumer-friendly nasal swab approach
• Overnight shipping to the individual and back to Quest with FedEx, leveraging their extensive logistics network
• Specimens shipped at room temperature, which eliminates the need for ice packs
• Availability for children less than 18 years of age (with adult supervision)
• Results reporting through the myQuest patient portal and mobile app
• Test data reported by Quest Diagnostics to the relevant departments of health as required
• The company plans to make the self-collection kits available through several channels, including for healthcare providers for patient care and healthcare workers as well as for states and organizations for return-to-work testing programs. Over time, the kits may also be made available to other employers as well as for individual users of the company’s QuestDirect consumer-initiated platform. The company will prioritize healthcare workers, first responders, law enforcement personnel and others critical to pandemic response to ensure they have timely access to the kit.

 
The company expects to have more than a half-million kits available by the end of June, with plans to make additional kits available on an ongoing basis.
 
LetsGetChecked gained an EUA of its COVID-19 Sure-track Test for at-home consumer use on May 29. It is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test. The test incorporates a nasal swab and PCR lab analysis. However, different from serology tests that detect antibody presence, this test determines the presence or absence of SARS-CoV-2 viral RNA.
 
According to the company, the Sure-track Test is the only FDA EUA-authorized at-home COVID-19 test that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis, and physician approval. The at-home test is accompanied by a connected platform offering 24/7 telehealth services supported by licensed healthcare professionals and timely guidance on containment and care for COVID-19-positive patients.
 
“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. 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.” said Peter Foley, LetsGetChecked founder and CEO told the press.
 
After a customer self-collects a swab sample, the collection swab is placed in a special transport tube containing a solution that deactivates the virus, ensuring everyone from shipping providers to lab technicians are protected from contamination and infection. Other tests on the market use a saline solution, which heightens risk by transporting an active virus. The solution also protects the integrity of the SARS-CoV-2 RNA, which heightens accuracy.
 
“The coronavirus crisis has impacted everyone and we are delighted to not only introduce a reliable testing solution, but one that is safe for everyone involved in the supply chain. Our entire system was considered as part of the review process and we are delighted to have worked with the FDA to deliver a truly unique at-home Coronavirus testing service to our customers,” said Gwen Murphy, Ph.D., MPH, and Director of Epidemiology and Clinical Studies at LetsGetChecked. “At-home testing will play a central role in ensuring a safe workplace and we are helping to develop and inform protocols with that in mind.”
 
With a current capacity of 300,000 units per week, LetsGetChecked’s own CLIA/CAP/BSL II certified high complexity laboratory based in Monrovia, Calif., aims to meet a capacity of millions per week.