A health technology company with a lab in Monrovia has received FDA authorization to market an at-home COVID-19 test kit that promises to deliver fast results.
The Sure-track Test was developed by LetsGetChecked, a New York-based direct-to-consumer business that sells home-health and wellness products. The kit uses a nasal swab to collect samples and is aimed at serving people most at risk of contracting the virus.
The company was granted emergency use authorization by the FDA. This allows the agency to authorize unapproved medical products or unapproved uses of approved medical products for use during an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions.
Sure-track is available for $129 per kit on www.LetsGetChecked.com for users who meet CDC criteria listed on the website’s guided-risk questionnaire. The criteria — which determines if someone might have, or is at risk of contracting the virus — addresses a variety of health conditions including difficulty breathing, a persistent cough, severe or constant dizziness, lung disease, diabetes, heart disease or chronic liver disease, among other ailments.
Those who think they may have come in contact with someone who has the virus would also meet the criteria for a test.
Sure-track users must pay for the test, but they can file a claim with their insurance company for reimbursement, company spokesman Stephen Wright said.
The market for at-home coronavirus testing has grown exponentially, but there is confusion surrounding the various technologies.
Dr. Paul Simon, chief science officer with the Los Angeles County Department of Public Health, said consumers should proceed with caution.
“There’s not a lot of oversight and, given the urgency, the FDA has allowed some loosening of procedures,” Simon said in a recent interview. “Testing is being done with materials that haven’t been formally approved or are in the pipeline to be approved.”
For those eager to test, CVS is opening 14 drive-through sites in California where people can self-administer the nasal swab test for diagnosing active virus, and Exer Urgent Care is among those offering both swab and antibody tests at its 16 locations in the Los Angeles area.
How it works
Unlike serology tests that detect the presence of antibodies, LetsGetChecked says its test determines the presence or absence of SARS-CoV-2 viral RNA, the strain of coronavirus that causes COVID-19.
Once a shallow swab sample is collected, it’s placed in a special transport tube containing a solution that deactivates the virus. That ensures that everyone from shipping providers to lab technicians is protected from contamination and infection. Users who mail their results immediately could get their results within 24 hours, the company said.
“We worked with the FDA for a couple months on this,” LetsGetChecked founder and CEO Peter Foley said. “Our EUA is quite unique because it encapsulates the entire supply chain. We weren’t just submitting part of it — but all of it.”
That includes all aspects of the testing service, including the collection-kit manufacturing process, logistics, lab analysis and physician approval.
Users download a mobile app to create their own accounts and a notification is sent when test results are completed.
“Anyone who gets a positive result is referred to our core nursing/physician team so they know what to do next,” Foley said.
Ramping up production
LetsGetChecked’s Monrovia lab is capable of producing 300,000 units per week, but the company is building toward a capacity of millions per week to meet the growing demand in all 50 states.
The company recently, partnered with the PGA on the TaylorMade Driving Relief tournament to administer tests both before and during the event.
Staff writer Teri Sforza contributed to this report.
