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Though atomic flu testing may be on the rise, acceptance of the platforms still decidedly lag abaft immunoassay flu testing in the physician appointment ambience in allotment because immunoassays accept been in the bazaar longer, said Piper Jaffray analyst William Quirk. Further, by accumulation agenda readers with immunoassays, BD and its adversary Quidel accept accustomed physicians a way to incrementally access acuteness after switching to a altered apprehension technology.



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In 2011, BD became the aboriginal accelerated affliction analysis arrangement that congenital a agenda readout of after-effects to accept authoritative OKs. The close now has 30,000 assemblage placements globally, with 75% in the U.S., Hopps said, abacus that about 40% of sales are for astute affliction settings, mainly in hospital EDs, and the blow are activated in physician offices and burning affliction centers, and added in retail clinics.



Quirk added that on an advancing basis, the advance amount for the cardinal of tests that use Quidel’s immunoassay instruments is college than the advance amount for all-embracing testing volumes as abstinent by the Centers for Disease Control and Prevention, an indicator of all-embracing flu testing advance acclimated by industry analysts.

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In a contempo balance call, Quidel’s CFO Randy Steward said that its absolute affliction acquirement grew 44% in the aboriginal division catastrophe Dec. 31, to $50.3 million, with 83% of the firm’s $45 actor of affliction accelerated immunoassay acquirement acquired from its automatic immunoassay platform.



While Quidel doesn’t acknowledge the names of its barter for aggressive reasons, it has civic affairs with some of the better burning affliction clinics in the country, Canaccord Genuity analyst Mark Massaro said. The close has point-of-care flu placements in 35,000 clinics, and it collaborates with abounding of the better analysis artefact distributors.

The payer mural for affliction testing can additionally access clinicians’ cerebration about which blazon of arrangement to implement, Massaro said. CMS and clandestine payer reimbursements for atomic affliction tests are about college than for immunoassay tests, he said, arch some clinicians to adjustment atomic point-of-care tests.

However, college atomic analytic analysis reimbursements are not accessible in all U.S. states. And because the upfront costs for such systems—some are added than $10,000—can be above the ability of some physicians, they may adopt to abandon the adventitious to accept college reimbursements and, instead, assignment with a lower-cost alternative, Massaro said.

A few industry participants additionally acclaimed that clinicians are aloof as adequate with adopting immunoassay as atomic technology because of a U.S. Food and Drug Administration reclassification of accelerated antigen affliction tests in 2017. In its reclassification, the FDA accustomed minimum requirements for acuteness and specificity for tests that accommodate immunoassay and atomic analytic technologies.

This adventure aboriginal appeared in our sister publication, Genomeweb.

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