As schools and businesses forge ahead with their reopening plans amid rising COVID-19 case numbers across the U.S., regular testing has become more crucial than ever—to the surprise of testmakers themselves, many of whom only a few weeks ago were predicting sharp financial downturns as diagnostic demand steadily dropped.
Among those scrambling to ramp production back up is LumiraDx. Barely two weeks after slashing the value of its proposed reverse merger with blank check company CA Healthcare Acquisition by almost half, citing the short-lived slow down in test purchases, the U.K.-based diagnostics maker has added a new COVID-19 assay to its U.S. offerings.
The antigen test kit is designed solely for use in monitoring outbreaks among schools, workplaces and other groups and organizations in real-time. It does so by testing up to five samples at once on LumiraDx’s portable, hand-held analyzer and returning results within about 12 minutes.Depending on the quantity of tests ordered, the cost per sample can fall as low as $4.
The test, which launched this week in the U.S., isn’t cleared or authorized by the FDA. Because these “surveillance” tests are meant to be used to monitor the spread of the coronavirus at a population rather than an individual level, using de-identified samples, the agency doesn’t regulate them. However, according to the FDA, if a tester plans to report patient-specific results of surveillance tests, they must be conducted in a CLIA-certified lab.
Though LumiraDx’s surveillance test hasn’t been verified by the FDA, the company says it returns results comparable to its standard antigen COVID test, which received an emergency use authorization from the agency last August. That test was found to detect nearly 98% of positive cases when compared to the findings of “gold-standard” PCR tests.
According to LumiraDx, the surveillance assay demonstrated 100% positive agreement with the standard version of the antigen test, and just over 96% negative agreement.
“Our rapid onsite COVID-19 surveillance test offers options that can fit into a variety of different use cases to support a safe return to school or the workplace and instill confidence in groups about their environment,” said Pooja Pathak, LumiraDx’s chief product officer. “By pooling up to five samples at one time, the LumiraDx SARS-CoV-2 Ag Surveillance test provides an efficient, accurate and cost-effective way to implement a surveillance testing program.”
The launch comes less than a month after LumiraDx snagged its second EUA from the FDA, this time for its COVID-19 antibody test. With that regulatory OK, both the antigen and antibody tests can be run on the same portable, point-of-care platform for rapid sample processing.
Despite these big wins, however, the company still proceeded at the end of August to slice $2 billion off the top of its proposed SPAC deal. After originally valuing the reverse merger at a cool $5 million when it was announced in April, LumiraDx dropped that valuation by about 40% and cut its full-year revenue guidance by even more.
At the time, the company attributed the more conservative valuation to declines in COVID testing and the “recent market environment for publicly traded diagnostic companies,” as well as to feedback from advisors and shareholders representing CA Healthcare Acquisition.