Physician Office Lab Market Gets a Shot in the Arm: Newly CLIA-Waived Alere i Molecular Flu Test

Physician Office Lab Market Gets a Shot in the Arm: Newly CLIA-Waived Alere i Molecular Flu Test

Rapid influenza (flu) testing is a high-profile fixture of the physician office laboratory (POL) diagnostics market. Easy-to-use lateral flow tests and other immunoassays run on automated readers are adequately reliable for primary care, urgent care and inpatient care settings. Such products also push infectious disease testing into the point-of-care (POC) and near-patient testing arena, allowing providers to initiate care during the same visit or day. Rapid flu tests represent significant revenue for POC diagnostics leaders such as Alere and Quidel as rapid flu testing has become ubiquitous in the developed healthcare systems of North America and Japan. Low risk, highly sensitive and specific molecular flu tests have been available for years from a technological standpoint, but only this month have become available from a regulatory standpoint. The newly CLIA-waived Alere I Influenza A&B test is expected to boost the value of the POL rapid flu test market and usher in a period of increased regulatory comfort with CLIA-waived molecular testing.

In the United States, the U.S. Food and Drug Administration (FDA) is able to grant IVD products waivers from Clinical Laboratory Improvement Amendments (CLIA) requirements, allowing healthcare providers with only a “certificate of waiver” to perform CLIA-waived tests with practically no regulatory oversight. Waived testing depends upon the availability of IVD products that require no dedicated training and are relatively low-risk, in terms of user error or impact upon patient health. Timely flu diagnosis is important to general physicians, urgent care clinics and retail clinics for the same-visit or same-day prescription of Tamiflu and other antiviral treatments. Similarly, hospitals can use flu tests to implement changes in patient clinical management or initiate antiviral treatment (when symptoms do not otherwise prompt default treatment during flu season).  Immunodiagnostic rapid flu tests are notoriously inaccurate - relative to other forms of clinical infectious disease testing - with false negatives the overwhelming problem.  Molecular rapid flu tests represent a significant improvement over traditional rapid flu tests in terms of sensitivity and their latent potential to differentiate strains.

Worth over $200 million in sales in previously strong flu seasons, the global rapid flu test market is primed for another above-average period on product innovations (capturing laxer regulatory requirements) and a strong flu season. Although far from matching the levels of demand in 2008-2009 resulting from an international flu pandemic, the current flu season should emerge through early 2015 as the strongest since the H1N1 season in terms of demand. While imprecise without full flu season results, reporting of influenza-like illness (ILI) cases to the CDC is illustrative of an auspicious start to the current season solely in terms of industry test sales:

  • Weeks 31-52 2009 total CDC-reported ILI cases - 642,468 (global flu pandemic saw more active months throughout the calendar year with a peak in late 2009)
  • Weeks 30-52 2010 - 222,883 cases (severe drop-off with overstocked inventories)
  • Weeks 31-52 2011 - 186,201 cases (weaker flu season)
  • Weeks 29-52 2012 - 303,679 cases (stronger season)
  • Weeks 31-52 2013 - 250,666 cases
  • Weeks 32-52 2014 - 329,619 cases

Projecting the trajectory of the flu season into the first quarter of 2015 is too complex and unreliable an endeavor to determine outstanding demand for flu tests in the remaining flu season. The CDC’s latest update noted that the severity of the season is similar to past H3N2 virus strain-predominant seasons and that ILI rates have already peaked in some U.S. regions but not yet in others. Clinician testing practices and test inventories will ultimately determine the course of the remaining seasonal market.

The POL rapid flu test market is largely held by manufacturers of CLIA-waived rapid immunoassay test kits featuring non-invasive nasal and nasopharyngeal patient sampling. The rapid tests provide results during the patient visit or within a half an hour. Quidel holds a global market lead over Alere in terms of POL rapid flu test sales, though Alere is the slight leader in overall rapid flu test sales. In the nascent market for POL molecular flu solutions, Alere has taken a decisive step over its competitors with a CLIA waiver for the Alere i test. Similar waivers could be in store for Verigene (Nanosphere), AmpliVue (Quidel), or GeneXpert (Cepheid).

With Alere’s CLIA waiver for its molecular flu solution, Kalorama Information expects 2015 sales of POL rapid molecular flu tests (and associated systems) of $5-10 million. Kalorama Information early in the year estimated the POL rapid flu test market at $55 million in 2014, retrospectively a somewhat conservative figure for a strong flu season (a result in part from a less effective vaccine and, qualitatively, the virulence of the H3N2 strain). In 2015, the rapid flu test market can expect to see some improved market fundamentals regardless the flu season as near-patient testers invest in new rapid molecular platforms for flu testing.

Kalorama Information’s latest report on the global POL market, Physician Office Laboratory Markets, 3rd Edition, is now available. The report comprehensively covers regional markets and test segments in the market for non-hospital, near-patient IVD product market.

Kalorama Information also offers a detailed look at the market space for point-of-care molecular testing with The Market and Potential for Molecular Point of Care Diagnostics.