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The test provides conclusive visual confirmation of the presence or absence of lesions that could develop into cervical cancer if they are left untreated.
The firm said that expanding the HDL cholesterol measurement range may enable its CardioChek analyzers to serve a larger population.
Lab directors selecting new instruments for antimicrobial testing may wait for clinical proof and then evaluate timing, throughput, and cost.
The test runs on Qiagen's Rotor-Gene Q MDx system and is designed to qualitatively detect the JAK2 V617F/G1849T allele in genomic DNA from whole blood.
The firm believes that its definitive monomicrobial test, which usually eliminates the need for additional validation testing, may give it an edge over competitors.
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.