Editor's note: On the same day this story was published, the FDA publicized the first Emergency Use Authorization of a serology test, Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test. This story has been updated to reflect that development.
On Tuesday morning, Los Angeles-based Bodysphere announced that it had received an Emergency Use Authorization (EUA) for a rapid COVID-19 serology test able to deliver results in as little as two minutes.
Word of the company product spread quickly across social media and several mainstream news publications, which highlighted the platform's quick turnaround time, and the impact that such a test could have on identifying those who should or should not self-quarantine.
However, Bodysphere's test was never acknowledged on the FDA's running list of in vitro diagnostic products that have received an EUA. Other news outlets that had reached out to the FDA for confirmation of the authorization received statements clarifying that the agency has not yet issued an EUA to any serology diagnostics for COVID-19.
Within a single day, Business Wire – a platform that uploads and disseminates press releases to media – pulled Bodysphere's announcement from its service, and several news outlets amended or fully retracted their coverage of the test. The company itself has since posted a statement from its CEO, Charlton E. Lui, describing the confusion as a misunderstanding on the part of Bodysphere.
"In the rush to get the desperately needed test kits to the front lines, Bodysphere believed when the manufacturer’s product was listed on the FDA Registry website, that was the [FDA's] notification the [EUA] was issued," he said in the online statement. "This misunderstanding does not in any way invalidate the test kits' authenticity or effectiveness."
The statement went on to note that Bodysphere's phone lines were "overwhelmed from calls around the world seeking to acquire these tests," an issue many news outlets noted as they tried to reach the company for clarification.
According to the now pulled announcement, Bodysphere's COVID-19 IgG/IgM Rapid Test Cassette detects antibodies for the virus in whole blood, serum or plasma, and, according to the company, performs with 91% specificity and 99% sensitivity. The platform was intended for use by medical professionals, and the company said that it was "positioned to have millions of test kits on the front lines in weeks."
The product page for the test is still accessible on Bodysphere's website, alongside listings for N95 face masks, three-ply disposable face masks and sanitizers. A note following Lui's update says that the company is now "anxiously awaiting the FDA's issuance of the EU to the manufacturer."
Although only one serology test has so far received the FDA's EUA, the agency does permit development and distribution of unreviewed antibody tests under certain limited circumstances highlighted in an FAQ on its website.
WHY IT MATTERS
The stories on Bodysphere's false authorization spread quickly, and for good reason: COVID-19 diagnostic testing has lagged in the U.S., and the current methodologies leave worried patients in the dark as they await the return of their testing results.
Many are actively seeking out updates as they navigate what is potentially the largest pandemic of their lifetimes, meaning that misinformation on proper guidance – or in this case upcoming diagnostic products – is primed to substantially harm efforts to contain the disease.
With public interest rising, and with more commercial manufacturers working on their own COVID-19 serology products, it's also worth noting the shortcomings of a rapid serology test that limit its use as a diagnostic (which the FDA highlights in its Q&A).
Because the body is still developing antibodies in the early days of an infection, these types of tests could provide a negative result if administered shortly after contact with the virus. Conversely, the test could also yield a positive result for patients who were previously infected with novel coronavirus but are no longer unwell, or even with another coronavirus strain, the agency writes.
In short: These tests would potentially help a professional spot a likely case and guide their patients appropriately, but follow-up testing with a molecular diagnostic would be necessary to either confirm or rule out a clinical diagnosis.
THE LARGER TREND
Bodysphere is just one of several companies that have been tripped up by shifting COVID-19 regulatory standards. In mid-March, an ambiguous guidance update from the agency saw a number of home-testing companies and telehealth providers scramble to announce mail-order COVID-19 testing services that, within days, were rescinded after the FDA clarified its stance against at-home offerings.
Throughout this, at least one digital health startup is hoping to thread the needle. Scanwell Health recently announced an at-home, smartphone-based serology-testing product licensed from the Chinese firm INNOVITA. Chief Medical Officer Dr. Jack Jeng told MobiHealthNews that his company has been pursuing an EUA for the mobile platform for weeks now, and suggested that it would be available roughly four to six weeks from now if authorized by the agency.
