CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all have high interest in contracting with this California company for mobile on-site testing that can deliver rapid results in minutes and molecular test results in hours. The company also offers antigen tests in its mobile labs.
NOW OPERATING IN THE CLINICAL LABORATORY MARKET is a California company with mobile laboratories in trailers that semi-tractors move to any client in the 48 contiguous states to do SARS-CoV-2 testing.
The company is SafeSite, a start-up company in Calabasas, Calif., that now operates five high-complexity mobile clinical laboratories that will be CLIA certified.
It launched its first testing operations last month.
New Competitor in Lab Tests
Not only is the clinical lab industry getting a new competitor, but this competitor offers a flexible, competitively-priced COVID-19 testing solution to clients of all types. In addition to the five labs already built, it is building 20 more mobile testing laboratories.
“Inside these mobile clinical laboratories, medical technologists (MTs) will offer tests for employers, job sites, schools, concerts, sporting events, and any entity or event needing on-site testing,” commented Lauren Rogen Sexton, RD, CDE, CEO of SafeSite.
“Inside these labs, SafeSite will use three tests for each worker or event participant. Sexton said that the three tests being used are:
• Bio-Rad Laboratories’ CFX Real-Time PCR (qPCR) Detection System;
• Quidel Corporation’s Sofia SARS Antigen FIA test;
• Abbott Laboratories’ ID Now COVID-19 point-of-care test.
This strategy of building CLIA-certified, high-complexity mobile testing labs that can go wherever they are needed is something any clinical laboratory could do as long as it is willing to invest the time and money. “Among employers, public and private schools, colleges and universities, large-event planners, and sporting venues there’s strong interest for on-site testing,” observed Sexton.
Background in Wellness
The owners of SafeSite have a background in wellness testing and working with other organizations serving consumer healthcare needs. At present, SafeSite is not affiliated with any clinical laboratories, hospitals, or health systems.
For some assignments, SafeSite’s mobile labs will be needed for no more than a few hours or a day, said Sexton, a registered dietitian, certified diabetes educator, and nutritionist. For others, the mobile labs may be needed every day for weeks or months, depending on clients’ needs.
Using these mobile clinical laboratories, SafeSite began SARS-CoV-2 testing for its first three clients last month. One was a sporting event and the other two were movie-production lots.
COVID Testing in Calif., Penn.
“One movie lot job was in Los Angeles where 200 movie studio employees were tested, and the other was in Pennsylvania where 40 employees were tested,” Sexton noted. “The movie production clients needed testing done onsite to screen the crews so that filming could begin.
“We started testing for COVID-19 during the last week of September and will go anywhere our clients need us,” commented Sexton. “We have a protocol-based testing module that we will use to establish a baseline for our clients to identify workers and students who are either positive or negative for the coronavirus.
“We use a combination of tests—including PCR assays, which are the gold standard—for patients exposed to the coronavirus,” she continued. “We also have an antigen test and a rapid test. We run those tests onsite from the first day and then each day thereafter that testing is needed onsite.”
Can Serve Different Entities
From its headquarters in Calabasas outside Los Angeles, SafeSite expects that many of its clients will be in the entertainment business, either movie or television studios, she added. SafeSite is also prepared to do testing at schools, concert sites, sporting events, and for employers—particularly manufacturing companies—that typically require staff to work in close proximity to each other, such as meat-packing plants, she said.
“Depending on the timeframe in which a client would need everyone tested, we will determine how many mobile labs we’ll have onsite,” Sexton explained. “Some of our entertainment clients will want us to start early in the morning so that we can spread out testing throughout the day. Other clients might want us for red-carpet events where they would need to test everyone within a few hours. In that case, we’ll have multiple mobile clinical labs onsite.”
SafeSite’s testing protocol calls for employees or event-attendees to be scheduled for testing according to each client’s needs. Some employees arriving for work may be asked to arrive early so that technicians can use nasopharyngeal swabs to collect specimens for the PCR and antigen tests.
Results Reported on Phones
Those who test negative with the rapid PCR test will get a wristband with a quick-response (QR) code and a text message on their mobile phones indicating they are safe to report for work. The text message will include a link to a QR code that the employer can scan to allow workers and event attendees to enter the workplace or venue.
Those who test positive with the rapid test would wait until the results of the Bio-Rad test are reported. The antigen test will be used for screening patients every day for the presence of the virus in their systems, Sexton said.
In May, when the FDA approved the Quidel Sofia antigen test for use in the United States, it said that such assays are specific for the presence of the virus but are not as sensitive as PCR tests. “This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection,” the agency added.
“One key to success in testing for COVID-19 is administering tests where they are needed, which is onsite,” Sexton commented. “The other key is producing rapid test results onsite, which we can do anywhere and at any time with our high-complexity mobile clinical labs.
“Any testing site that does not provide results immediately or at least in a few minutes or hours is not a viable solution if we want to stop the spread of the virus,” she added. For accommodating large numbers of individuals needing testing, SafeSite also can set up sample collection bays in tents, the company said.
Innovators Target Lab Testing
Clinical laboratory administrators and pathologists looking at the marketplace strategically will want to watch how companies like SafeSite are innovating in response to the urgent demand for greater numbers of COVID-19 tests. Because of how it was serving the entertainment industry and organizers of special events, SafeSite had unique experience in using trailers as a way to deliver a service at one time and place, and then moving that trailer to the next event or project site.
The Dark Report wrote about another company that is developing laboratories in shipping containers that can be certified as high-complexity CLIA labs. Clarity Lab Solutions in Boca Raton, Fla., is partnering with SG Blocks Inc., of New York on this effort. In response to the demand for COVID-19 tests, their business plan is to speedily build and deliver shipping container-based labs to clients that are cheaper than traditional construction. (See TDR, “New York Firm to Build CLIA Laboratories in Shipping Containers,” Sept. 14, 2020.)
These are just two examples of how the COVID-19 pandemic is motivating outsiders to enter the clinical laboratory market with solutions they believe will be disruptive and allow them to profit.
Safesite’s Labs on Wheels Can Be Different Lengths
SAFESITE’S MOBILE CLINICAL LABORATORIES come in three different configurations that range in size from 20-foot-long to 50-foot-long trailers.
The longer mobile laboratories can accommodate 10 bays for clinicians to meet with patients and collect specimens.
The shorter mobile labs contain five to eight patient bays. There’s also room for testing instruments, an entrance door on one side, and an exit door on the back.
The patient bays line the walls on each side of the trailers, separated by a corridor down the middle. Patients would enter at one end, show their appointment codes on their mobile phones, get tested, and then exit out the rear door.
The number of tests SafeSite can run per day would depend on each client’s needs and what testing protocol SafeSite would recommend to meet those needs, company officials said.
Some COVID-19 tests will take about 15 minutes to produce a result. Therefore, a mobile lab in a trailer that has five bays producing a test result every 15 minutes could produce 200 tests in a 10-hour day. Theoretically, an eight-bay trailer could produce 320 tests in 10 hours, and a 10-bay trailer could produce 400 tests in 10 hours.
An RT-PCR instrument in the mobile lab could run 96 samples on a 96-well plate in about 75 minutes, company officials added. Over the course of a day, one mobile lab could run 768 tests in a 10-hour day.
A second trailer configured in the same way could double that number of tests, company officials said.
Contact Lauren Rogen Sexton at firstname.lastname@example.org.