The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
Within diagnostics, the firm posted molecular diagnostics revenues of $164.3 million, up 11 percent from $148.6 million in fiscal Q1 2018.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
Abbott CEO Miles White is bullish on the firm's Alinity systems, while Quest and LabCorp see acquisitions as the likely result of further PAMA-related cuts.
The company's diagnostics, diagnostics excluding blood, and breast health divisions are all anticipated to post healthy year-over-year improvements.
The firm noted that it has already borrowed $350 million under the revolving credit facility. The funds may be used for general corporate and other purposes.
November's modest gain followed a tough October, when the index down almost 9 percent. Meridian Bio paced the gainers, and NantHealth was the steepest decliner.
MDx revenues increased 3 percent to $158.0 million, but excluding non-recurring royalty revenue in the prior-year period, MDx revenues increased 10 percent.
Smaller multiplex molecular panels of five or fewer targets will be covered, while a determination of gastrointestinal panel coverage is expected soon.
Qiagen's partnership and merger agreement with NeuMoDx may help it compete with high-volume molecular testing vendors such as Abbott, Hologic, and Roche.