Providers switching flu testing options under pressure to compete with Walgreens, CVS

As they determine whether their patients have the flu or not, providers have two choices: the more routine and cheaper, rapid influenza diagnostic tests, or the more complex and costlier molecular tests.

Until recently, culture-based flu testing was the norm. But with a time-to-result of three to 10 days for culture testing, healthcare providers are turning to point-of-care rapid tests that can achieve results in about 15 minutes or less.

RIDTs have now become the method of choice for many clinicians, but according to industry executives, molecular testing may be slowly gaining ground.

In 2018, providers completed between 35 million and 40 million flu tests in the U.S., including RIDTs that use immunoassay technology and molecular tests, flu testing company executives said.

Influenza tests completed at the point of care in the U.S. account for about 75% to 80% of the $300 million and $350 million per year market for respiratory testing, said Troy Hopps, global platform leader for point of care at BD Diagnostic Systems.

By his estimates, RIDT influenza tests based on immunoassay technology are growing at 4% per year, and those based on molecular technology are growing at 15% on significantly lower year-over-year revenue comparisons.

Experts say overall POC influenza testing growth is driven by consumers' expectations.

For example, Chicago's NorthShore University HealthSystem has expanded a pilot project it began in 2016 when it established two centers that provide physician and on-site testing services. The health system uses a molecular test for influenza A, influenza B, and respiratory syncytial virus in its primary care centers and hospital emergency department.

The decision to implement point-of-care testing was driven mainly by competition with Walgreens and CVS Health that are increasingly offering such tests in clinics, said Zac Zahara, an assistant vice president of pathology and laboratory medicine at NorthShore.

NorthShore—which has 1,000 physicians, four hospitals and 100 primary care centers—uses point-of-care instruments for flu testing in about 25 care centers, up from about two in 2016, Zahara said. Within hospitals, flu testing is usually batch-processed in a lab, but the point-of-care instruments are deployed where faster results are needed, such as in the ED.

Among diagnostic companies selling POC flu tests, Becton Dickinson said it is seeing an uptick in placements of its RIDT flu testing platforms at physician offices, urgent care clinics, and retail pharmacy centers, Hopps said, adding that retailers and pharmacies offering flu testing are looking at point-of-care testing, including for flu, as a way to attract and retain customers.

Of the total number of tests currently completed at the point of care in the U.S., most—about 25 million—are currently done each year in physician labs, which include doctors' offices, urgent care centers and retail centers. The rest are done in hospitals, mainly in emergency departments.

A 10- to 15-minute flu test offered by a pharmacy that can then prescribe an antiviral is convenient.

In addition to increased seasonal incidence of influenza, growing awareness among consumers of such drugs and the increase in their prescription is also driving POC testing overall, said Steven Sepúlveda, vice president of global business development and channel management at Mesa Biotech.

Treatments work best within 48 hours of the symptoms' onset, so sending out samples to the lab and waiting days for results can be ineffective, he said.

As the overall flu testing market expands, the fight for market leadership continues between those firms offering RIDTs and those providing molecular testing for flu.

Providing ammunition to molecular diagnostic testing for flu are guidelines updated by the Infectious Diseases Society of American in 2018 that urged the use of molecular-based flu testing.

According to Roche, the drive toward better antibiotic stewardship practices is pushing market demand for molecular tests, in particular. Point-of-care tests for influenza are helping systems seeking ways to align with their quality reporting requirements, said Jason Dukarm, group marketing manager for point-of-care at Roche Diagnostics.

"In the move toward value-based care, use of a molecular device that gives you a definitive result—whether it is in the emergency room, an affiliated clinic or a physician's practice—creates greater certainty on how the patient should be treated," he said, adding that point-of-care testing is helping health organizations implement "the best stewardship associated with overprescription of antibiotics."

Clinicians purchasing POC influenza systems are also taking note of the high sensitivity levels of molecular tests. According to Abbott, when clinicians use a direct nasal swab for influenza testing, the test has a 96% sensitivity for influenza A and a 100% sensitivity for influenza B. The platform has a 97% specificity for detecting influenza A and a 97% specificity for detecting influenza B.

Norman Moore, director of scientific affairs for infectious disease at Abbott, said that "when it comes to flu testing in a point-of-care setting, sensitivity is only impactful if results are delivered quickly. If results cannot be given while the patient is still in the hospital, urgent care setting or doctor's office, the doctor may be more likely to base treatment decisions on symptoms."

David Persing, executive vice president and chief medical and technology officer at molecular diagnostics company Cepheid, believes that while rapid antigen testing is the dominant testing modality for the flu, it is "being steadily replaced" by molecular diagnostic tests, and all vendors of such systems are seeing "significant uptake of molecular options."

Because of their higher sensitivity, molecular tests are more adept than immunoassay tests at handling different types of samples; managing challenges associated with sample collection by users with varying levels of experience; and handling low viral loads that can throw off less sensitive tests, Persing said.

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.