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.
A busy second day of the JP Morgan conference saw Thermo Fisher's Marc Casper discuss the firm's R&D focus and Exact Sciences' Kevin Conroy discuss plans for Cologuard sales growth.
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.
PacBio's shares skyrocketed 76 percent in November on the news that Illumina plans to acquire the firm for $1.2 billion in cash.
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.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.