Though molecular flu testing may be on the rise, adoption of the platforms still significantly lag behind immunoassay flu testing in the physician office setting in part because immunoassays have been in the market longer, said Piper Jaffray analyst William Quirk. Further, by combining digital readers with immunoassays, BD and its competitor Quidel have given physicians a way to incrementally increase sensitivity without switching to a different detection technology.
In 2011, BD became the first rapid influenza test system that incorporated a digital readout of results to receive regulatory OKs. The firm now has 30,000 unit placements globally, with 75% in the U.S., Hopps said, adding that about 40% of sales are for acute care settings, mainly in hospital EDs, and the rest are applied in physician offices and urgent care centers, and increasingly in retail clinics.
On an ongoing basis, the growth rate for the number of tests that use Quidel's immunoassay instruments is higher than the growth rate for overall testing volumes as measured by the Centers for Disease Control and Prevention, an indicator of overall flu testing growth used by industry analysts, Quirk added.
In a recent earnings call, Quidel's CFO Randy Steward said its total influenza revenue grew 44% in the fourth quarter ending Dec. 31, to $50.3 million, with 83% of the firm's $45 million of influenza rapid immunoassay revenue derived from its automated immunoassay platform.
While Quidel doesn't disclose the names of its customers for competitive reasons, it has national contracts with some of the largest urgent care clinics in the country, Canaccord Genuity analyst Mark Massaro said. The firm has point-of-care flu placements in 35,000 clinics, and it collaborates with many of the largest test product distributors.
The payer landscape for influenza testing can also influence clinicians' thinking about which type of system to implement, Massaro said. CMS and private payer reimbursements for molecular influenza tests are generally higher than for immunoassay tests, he said, leading some clinicians to order molecular point-of-care tests.
However, higher molecular diagnostic test reimbursements are not available in all U.S. states. And because the upfront costs for such systems—some are more than $10,000—can be beyond the reach of some physicians, they may prefer to forgo the chance to receive higher reimbursements and, instead, work with a lower-cost alternative, Massaro said.
A few industry participants also noted that clinicians are just as comfortable with adopting immunoassay as molecular technology because of a U.S. Food and Drug Administration reclassification of rapid antigen influenza tests in 2017. In its reclassification, the FDA established minimum requirements for sensitivity and specificity for tests that include immunoassay and molecular diagnostic technologies.
This story first appeared in our sister publication, Genomeweb.