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Quidel

Rapid immunoassay product revenues — including sales from the firm's QuickVue, Sofia, and Eye Health products — rose 40 percent year over year.

The company claims its test can detect the Lyme-linked chemokine CXCL13 in human cerebrospinal fluid within 20 minutes.

The agency cleared two Roche tests that run on its Cobas systems. One does Chlamydia trachomatis and Neisseria gonorrhoeae testing and the other does hematology testing.

Using an immunoassay as an initial screening tool saved approximately $36,000 over multiplex PCR panel use alone when performed in a period of high flu prevalence.

Seventeen of the 25 companies in the 360Dx Index saw their shares decline last month. Invitae paced the decliners, while GenMark led the gainers.

The investment bank based the upgrade on potential for growth in the installed base of Quidel's immunoassay and molecular instruments, among other factors.

Among companies whose tests were greenlighted by the FDA last month, Quidel received clearances for a test to detect and differentiate influenza types A and B, and for a separate test for Lyme disease.

The test was previously cleared to run on the Sofia platform and can rapidly differentiate human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens.

The increased revenues were due primarily to cardiac immunoassay sales from the newly acquired Triage and BNP businesses as well as increased sales of rapid immunoassay products.

The immunoassay allows for the rapid detection of influenza types A and B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.

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