The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.
LightDeck Diagnostics was awarded a $5.65 million contract to develop a rapid antigen test to detect SARS-CoV-2. The funding, provided by the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (HHS), is enough to advance the test to commercialization.
“The LightDeck COVID-19 Antigen Test is portable and delivers lab quality results in about five minutes, and is more sensitive than the lateral flow membrane assays available today,” Byron Hewett, president of the in vitro diagnostics business at LightDeck Diagnostics, told BioSpace.
The advantage of a rapid antigen test is that an infected individual can be detected and isolated in real time and contact tracing can be done right away.
Importantly, LightDeck Diagnostics’ rapid antigen test for SARS-CoV-2 also is easy for untrained personnel to use. “An interior nasal swab is put into a lysed buffer. An aliquot of that sample is put into the LightDeck cartridge. There are no other reagents to add. Once the cartridge is inserted into the analyzer, everything needed to analyze the sample is there,” Hewett explained.
Inside the cartridge, the sample mixes with a reagent pellet and fluorescent dye binds to the target molecules. When the cartridge is inserted into the analyzer, the sample flows into the reaction chamber, where the target binds to the capture reagent on the waveguide. Then a laser is focused through the lens on the cartridge, causing the target molecules to fluoresce. A built-in camera captures the light signal. Within about five minutes, that signal is translated into quantifiable results. Importantly, the cartridge includes controls to show that the analysis is correct.
“Internally, the sensitivity and specificity data are very encouraging,” Hewett said.
The LightDeck COVID-19 Antigen Test leverages that sensitivity and specificity, to return results that are better than currently-available lateral flow-based tests requiring at least 15 minutes to deliver results. Its cost-effective manufacturing technologies suggest the test will be affordable, as well as fast and accurate.
“Antigen tests today are based on cutoffs. If a sample is above the cutoff, it’s positive. If below, it’s negative,” Hewett explained. “With our technology, you can reproducibly measure the amount of fluorescence to stage patients based on where they are in the course of the disease.”
As David Okrongly, LightDeck Diagnostics’ CSO, said in a statement, “To stop the spread of COVID-19 and put an end to this pandemic, we need a public health strategy that includes national testing with widespread, and frequent, on-the-spot lab-quality testing.”
To detect infected individuals, rapid antigen tests represent an important adjunct to PCR testing.
Because this antigen test is both portable and easy to use, point-of-care antigen testing will become readily available for use not just at clinics but also at airports, large events and even mass vaccination sites, to better manage the spread of COVID-19. “This will help drive adoption in the market,” Hewett noted.
“There’s a lot of pushback around the performance of lateral flow assays, so this is an opportunity for a better test,” Hewett said. For example, RT-PCR tests results typically take several hours to complete and one day or longer to deliver results. An assay that can deliver results at the point of care makes COVID-19 testing feasible for broad population studies and just-in-time testing, allowing people to limit their exposure and to facilitate real-time contact tracing.
The light-directed COVID-19 antigen test begins clinical trials this month. Currently, it runs one sample at a time for a throughput of 10 to 12 samples per hour. Hewett said he expects to file for an emergency use authorization with the FDA during the second quarter of this year.
The LightDeck COVID-19 Antigen Test will build on the existing product platform,” Chris Myatt, CEO and founder of LightDeck Diagnostics, said in a statement. The company
already has an antibody test for SARS-CoV-2 that offers 97.9% sensitivity and 99.6% specificity. It also is developing tests for sepsis and heart indications, and is shipping thyroid and hormone tests to the veterinary market and water tests to the environmental industry.
“Every minute matters when we’re dealing with infectious diseases,” Myatt said. “We believe our technology can provide an optimal solution to the current gaps in COVID-19 diagnostic testing on a national level.”
“The BARDA funding was timely,” Hewett added. In October, LightDeck Diagnostics announced $11 million in Series B funding to support the development and commercialization of its in vitro multiplex tests for several panels, including COVID-19. Those funds, along with the BARDA contract (number 75A50121P00026), will enable the company to deliver on its vision of a comprehensive COVID-19 testing strategy.
