Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.

The assay also has the CE mark, which the company said it obtained May 8.

Also of note, the assay can run on seven possible thermocyclers – Applied Biosystems 7500 Standard, Applied Biosystems 7500 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche Lightcycler 480, Roche Cobas z480, and Thermo Fisher Quantstudio 7 Pro.

Pandemic

Quidel has been riding high as of late, taking a lead during the pandemic in terms of testing. To that end, the company’s molecular diagnostic solutions category increased 45% in the first quarter to $8.4 million. “This growth was primarily driven by the respiratory season as influenza revenue grew 120% and strep A grew 24%,” said Randy Steward, Quidel’s CFO, during a May 6 call on first-quarter results. “Adding to the overall molecular growth, the Lyra product category grew to $1.7 million in the quarter, driven by $1 million in sales of our Lyra SARS-CoV-2 product, which [was] granted EUA approval by the FDA on March 17.” That test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their health care provider.

That win was followed by big news from the FDA. Earlier this month, for example, the agency issued such an authorization for an antigen test for the SARS-CoV-2 virus that is more readily deployed than other diagnostic tests for the pathogen.

Of note, the Sofia test relies on nasal or nasopharyngeal specimens and can be analyzed on automated or manual analyzers. Health care professionals can obtain the kits from Cardinal Health and other sources.

‘At this almost full-time

During the virtual Bank of America Merrill Lynch Healthcare Conference May 13, analyst Xiaoxiao Ma asked CEO Doug Bryant about the company’s progress during the pandemic.

“Well, I'll start just by saying that we've been at this almost full-time since Randy and I got back from our meeting at the White House, on March 4,” Bryant began, highlighting that by March 17, the company had developed an assay for its brand of PCR products called Lyra and received the EUA at that time. Subsequently, the company ramped up its volumes to manufacture 1,000 kits a day, or about 480,000 tests per week.

He also highlighted the potential of the Lyra Direct PCR assay, for which the company was in the process of securing the EUA at the time.

Capturing attention

One analyst who has been excited about Quidel’s prospects is William Blair’s Brian Weinstein. When the company unveiled its first-quarter results, he noted that the $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza. “On the earnings front, EBITDA were around $70 million (40% margin) and EPS were $1.22, which simply crushed our paltry estimates of $59.6 million and $0.99, respectively.”

More recently, he highlighted the EUA for the Sofia 2 SARS Antigen FIA in a May 11 note. "[W]e believe this can provide a significant boost to the testing infrastructure in the U.S. by adding what could wind up being more than 1 million tests per week on an installed base of 36,000 instruments in the United States (two-thirds of which are Sofia 2 instruments).”

He went on to note that being able to use the Virena real-time data management system could provide a way to pinpoint disease hotspots, allowing for the proper allocation of resources. He went on to label the approval as “landmark,” potentially leading to “astonishing” revenue and cash flow.

Looking at the total picture, Weinstein saw great potential with Sofia. "When adding in the company’s Lyra molecular assay, which we again conservatively model, we add another roughly $100 million of revenue. In total, our revenue target that had stood at $563 million now goes to about $860 million.”