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Abbott

The firm said that its test is the first on the market to detect RSV infection at the point of care in 13 minutes or less.

The firm wants to develop a test that can provide objective, reliable, and rapid information so that clinicians can make critical decisions in circumstances of high uncertainty.

Molecular and point-of-care test revenues are showing promising growth in global diagnostics markets, but immunochemistry tests dominate overall. 

The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November. 

Companies with diverse infectious disease diagnostic technology offerings said that molecular methods are complementary to, not competitive with traditional diagnostics.

Abbott's commitment to closing the deal is still uncertain, but Alere's CEO said the regulatory clearance marks a "significant milestone." 

Separately, Alere said today that the European Commission has granted clearance for its acquistion by Abbott.

Alere sent a special submission to FDA because of a modification to the Alere i Influenza A & B to address an identified mismatch with certain Flu B strains.

The firm said it has received CE marks for its blood and plasma screening system, as well as its clinical chemistry and immunoassay diagnostics systems.

The accreditation covers postmortem and human performance toxicology analysis, including driving under the influence of drugs and alcohol testing. 

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