NEW YORK – Having gained its footing through COVID-19 testing at schools, universities, and corporate campuses, Shield T3 is looking to broaden its reach and diversify its product line of easy-to-access PCR-based tests.
The University of Illinois spinout currently supplies saliva-based COVID-19 testing to about 100 institutions in California, Illinois, and Washington, D.C., and late last month the firm launched its combination COVID-19, influenza A and B, and respiratory syncytial virus tests. It started distributing many of those tests this summer through vending machines in California before adding the machines to its Illinois and D.C. markets.
Chris Lemelle, chief medical officer for Shield T3 Health, said the company hopes to expand from 50 vending machines to 250 by early 2023, with further growth in three or four regional markets during the year. He said the company also hopes to soon stock those machines — and retailers' shelves — with a broader range of tests as well as eventually shift testing into homes.
"We are currently in talks with large retail chains to place our offerings in-store while building a site for online distribution, as well," he said.
Lemelle isn't ready to reveal details on the firm's upcoming products other than it has "five or so" more assays set to emerge from the pipeline this year and is developing a home-use instrument capable of laboratory-quality PCR testing.
The company's commercial COVID-19 assay is built on the CovidShield technology that U of I used for COVID-19 testing on its three campuses starting in 2020. The university gained US Food and Drug Administration Emergency Use Authorization for the RT-PCR-based test in March 2021. Lemelle said Shield T3 is backed by the U of I yet run as an independent company, which gives the firm expanded access to technology, patents, and research results.
"Even though they are the stakeholders and we report our progress and performance to them, we're independently operated and owned by a usual C-suite corporate structure," he said.
Five partner laboratories across the country are processing Shield T3 samples so far, and the company plans to soon begin offering tests from two more, Lemelle said. Those laboratories together will give the company the capability to serve customers across the 48 contiguous states.
At the institutions with Shield T3's vending machines, taking a test involves scanning a QR code, registering for a test, collecting saliva with the provided kit, and dropping it in a box by the machine. Shield T3's other client institutions have established locations to hand over samples to staff or leave them in collection boxes. The company delivers results within 24 hours by text message and email.
The COVID-19 test costs about $40, depending on the location and size of the contract with the institution using Shield T3's tests, and the combination test costs $50-$80, Lemelle said. Shield T3's payment models vary by contract and involve payments from the clients, user credit cards, and insurance companies.
The test has myriad competitors among over-the counter rapid antigen tests, point-of-care tests administered by healthcare providers, and laboratory-based tests for COVID-19. Among test developers who have developed saliva-based diagnostic tests for SARS-CoV-2 are MicroGem, which gained an FDA EUA in April for its MicroGem Sal6830 SARS-CoV-2 Saliva Test, a 30-minute assay that uses cartridge-collected samples run on the company's point-of-care RT-PCR system. The company's technology uses thermophilic enzymes, nanoparticle-mediated cell capture, and high-temperature lysis to capture intact viruses and extract nucleic acids.
Also, Aptitude Medical offers its over-the-counter saliva- or nasal swab-based tests, which run on a phone-sized reader used by healthcare providers and individuals. That firm secured an FDA EUA for those tests in October.
The labs using Yale's SalivaDirect RT-qPCR testing protocol have a similar model to that of Shield T3, using individual saliva sample collection and laboratory-delivered results. University researchers found early in the pandemic that saliva samples contained higher SARS-CoV-2 viral loads than nasopharyngeal swabs, and saliva-based tests could help identify more asymptomatic infections, and the protocol was developed at the Yale School of Public Health.
In a preprint study published in April 2020 at MedRxiv — and published as a letter to the editor later that year in The New England Journal of Medicine — a group of authors from Yale University and Yale-New Haven Health wrote that they found PCR tests on saliva samples were more sensitive and less variable than nasopharyngeal swab specimens. They noted in their NEJM letter that the participants included 70 patients with COVID-19 and 495 asymptomatic healthcare workers, and seven of those healthcare workers were positive for SARS-CoV-2 in saliva samples despite negative tests using nasopharyngeal swab samples the same day.
Two systematic review articles published a year later by JAMA Internal Medicine and the Annals of Internal Medicine found similar sensitivity among assays using saliva or nasopharyngeal samples. Another systematic review published at the time by the Journal of Clinical Microbiology found that testing using nasopharyngeal swab samples performed slightly better than those using saliva samples.
Peter Lee, VP for corporate and strategic development at MicroGem, said saliva is a challenging medium for COVID-19 testing because it contains substances such as mucus, enzymes, epithelial cells, bacteria, and non-target viruses. But the noninvasive sample collection can be more pleasant than a healthcare worker-collected swab sample, plus he cited the research from Yale as an indication SARS-CoV-2 may be present in saliva samples earlier than it appears in nasal swabs.
"As a diagnostic, obviously that's very important and that speaks to the potential power of using saliva as a sample type," he said in an interview.
B. Scott Ferguson, CEO of Aptitude Medical Systems, said his company is trying to make molecular diagnostics more widely accessible with results as accurate as an RT-PCR assay processed in a laboratory. Aptitude is also developing multiplex tests for COVID-19 and influenza, a combination test for COVID-19, influenza, and RSV, and tests for sexually transmitted infections.
"Molecular tests provide unique value that you just can't get with an antigen test," Ferguson said. "Through the enhanced sensitivity, you can find out if you're potentially positive before you would have with an antigen test and that can influence your behavior."
Lemelle said Shield T3 is not trying to compete with reference laboratories like Quest Diagnostics or Laboratory Corporation of America that perform lab-based COVID-19 testing but is instead trying to distinguish itself by performing well in the home-based testing market. He said the company can distinguish itself by broadening its line of services beyond in vitro diagnostics and expanding into other methods of diagnosis, such as diagnostics that incorporate patient-collected data, as well as continuing to offer its PCR assays at lower cost than competitors.
He thinks Shield T3's vending machines follow an overall shift in public preferences away from full-service testing sites and toward a model that lets them "get healthcare closer to where they are."