More than a year after Quidel’s Lyra PCR assay for COVID-19 was granted emergency use authorization by the FDA, the agency has slapped a Class I label on a widespread recall of the tests.
Quidel initiated the recall after discovering the lab test posed a “significant risk” of returning false negative results, per an FDA statement. Interestingly, that risk was linked not to patients with easily overlooked trace amounts of the coronavirus in their nasopharyngeal or oropharyngeal swab samples, but to those with relatively high amounts of the virus.
The samples at most risk are those registering a cycle-threshold value of 5 or less—indicating a higher viral load—when tested using certain PCR thermocyclers from Thermo Fisher's Applied Biosystems brand, Bio-Rad, Roche and Qiagen.
According to the recall notice, labs using those thermocyclers to analyze the Quidel Lyra test should dilute and re-test any samples that initially return a cycle-threshold value of 5 or below, then interpret those results in accordance with Quidel’s updated instructions for use for the assay.
The recall covers more than three dozen lots of the test, spanning 18,385 kits, each of which can be used to perform 96 analyses. The affected kits were manufactured between March 2020 and March 2021 and were distributed between mid-March 2020 and the end of May this year.
Quidel has so far received five complaints regarding the assay. And while no injuries or deaths have been linked to the issues with the test, the FDA noted that false negatives could lead to serious illness and death for those tested and anyone they come into contact with—explaining why the recall was given a Class I label, the agency’s most serious.
Despite the classification, the Lyra tests aren't being recalled "in the common understanding of the term," Quidel said in a statement sent to Fierce Medtech. Rather than asking labs and hospitals to return any tests, the FDA's guidance was issued to alert the public of Quidel's updated instructions for interpreting the results of the test.
The Lyra test was among the first to receive emergency authorization by the FDA. That EUA came on March 17, less than a week after Roche’s Cobas high-volume PCR diagnostic became the first commercially developed COVID test to get the go-ahead.
The Lyra assay was cleared for use in analyzing the nasopharyngeal or oropharyngeal samples of patients whose healthcare providers suspect them of having the virus, and can only be ordered by a physician and tested in a CLIA-certified lab.
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Other diagnostic makers have recently begun to walk back their financial projections for the year as demand for COVID testing in the U.S. dries up alongside rising vaccination numbers. But in a May 6 investor call about the company’s first-quarter results, CEO Doug Bryant highlighted Lyra’s “reasonably stable” performance and said the company had yet to observe the “falloff” that competitors were experiencing with their own PCR tests.
That call came a little over a week after Quidel informed labs of the false negative risk and sent out the assay’s updated instructions for use and interpretation on April 26. Bryant did not discuss the recall during the conference call, nor was it mentioned in the financial report.
In addition to Lyra, Quidel has received additional emergency authorizations for a handful of other coronavirus tests. Its QuickVue rapid antigen test, for one, is now available for purchase from Amazon and Walgreens for at-home use, while its artificial intelligence-powered Sofia device recently received an expanded EUA for rapid point-of-care testing.
Editor's note: This story was updated on July 13 with clarification from Quidel about the nature of the recall.