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.
Smaller multiplex molecular panels of five or fewer targets will be covered, while a determination of gastrointestinal panel coverage is expected soon.
NPR reports that researchers in Italy are testing a gene drive aimed at controlling mosquito populations.
Researchers may experience the effects of the government shutdown for a while, the Los Angeles Times reports.
A new study finds that the majority of patients at a Tijuana clinic received a diagnosis after first-line genome sequencing, the San Diego Union-Tribune reports.
In Genome Biology this week: post-transcriptional modification-based stratification of glioblastoma, single-cell analysis of gene expression and methylation in human iPSCs, and more.