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The firm reported preliminary revenues of $246,000 for 2016, and said that after receiving FDA clearance, it expects a lift in sales of its ID/AST blood-based infection test.
The FDA cleared the test to enable clinicians to provide better antibiotic treatment to patients with lower respiratory tract infections or sepsis.
The PhenoTest BC Kit identifies organisms that cause bloodstream infections and provides information about antibiotic sensitivity.
New minimum performance requirements may reduce the number of misdiagnosed influenza infections, according to the FDA.
The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux.
The kits are the first reagents cleared by the FDA for detecting antineutrophil cytoplasmic antibodies on an automated digital IFA microscope, Inova Dx said.
Seeker quantitatively measures the activity of lysosomal enzymes that may suggest lysosomal storage diseases.
Commenters told the FDA that antigen-based rapid influenza diagnostic tests have performed poorly, and the reclassification will "mitigate" health risks.
The firm said that the push toward outcomes-based medicine will drive innovation in diagnostic wearables and smart textiles over the next few years.