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.
The deal covers distribution of the SpeeDx ResistancePlus and PlexPCR assays.
The company also reaffirmed its guidance for the fourth quarter, and continues to expect revenues of $46.5 million to $48.0 million and EPS of $.09 to $.11.
As part of the deal, which is worth at least $3 million for the first five years, Primerdesign will develop and supply 384-well plate molecular assay panels for Genesis.
The technology works directly from clinical samples and can potentially be multiplexed to detect tens of targets, according to the firm.
The firm plans to use the funds to develop a five-minute point-of-care molecular diagnostic system for multiplexed infectious disease detection.
Bruker plans to acquire an 80 percent stake in Hain, which has capabilities in tuberculosis and mycobacteria testing as well as virology and human genetics.
Revenues for Roche Diagnostics totaled CHF 6.26 billion for H1, driven primarily by demand for immunodiagnostic solutions.
The firm’s two-step multiplexed-tandem PCR tool identifies low concentrations of multiple STI pathogens in samples with high concentrations of other pathogens in three hours.
The multiplex real-time PCR assay enables the simultaneous detection of Trichomonas vaginalis or Mycoplasma genitalium in urine and vaginal samples.
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.