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 firm said it raised €55.5 million to fund the expansion of its Idylla test platform, its sales and marketing activities, and other general corporate purposes.
The deal covers distribution of the SpeeDx ResistancePlus and PlexPCR assays.
The Boston-based startup will use the funds to expedite prototype development of its sample preparation technology and computational approach.
Alere rapid diagnostics revenues were $548 million in the quarter, driven by infectious disease and cardiometabolic testing product sales.
The Belgium-based firm plans to use the proceeds to fund expansion of the Idylla test platform, sales and marketing activities, and additional general corporate purposes.
New funding will support assay development and lab space to offer test services, and ultimately a test kit using the firm's resistance database.
Researchers showed that the test had equivalent results to a lab-based assay and has the potential for a faster turnaround time.
Its most advanced gene expression signatures are for infectious disease diagnostics and are aimed at enabling the appropriate prescription of antiviral and antibiotic medications.
MSK researchers showed that high TMB may be associated with improved survival across tumor types, but the cut-offs for high and low status will vary based on histology.
Meridian CEO Jack Kenny said the firm needs to develop a new MDx platform, while Genapsys resurfaced with an update on its portable sequencing platform.
The molecular test detects and differentiates Bordetella pertussis and Bordetella parapertussis from fresh and frozen nasopharyngeal swab samples.
At JP Morgan, Qiagen CEO Peer Schatz discussed a new digital PCR system and handheld reader for TB testing; Qiagen's acquisition of N-of-One; and its new sample prep system.
The test combines qPCR and microarray technology to detect carbapenemase-producing enterobacteriaceae, a bacteria resistance to carbapenem antibiotics.
Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.
Despite a recent positive economic modeling study, the debate over appropriate use of the ME panel seems likely to continue until more outcomes studies are conducted.
Using real-time nanopore metagenomic sequencing, researchers ruled out enhanced human-to-human transmission of Lassa virus during an outbreak in Nigeria last year.
The cholera epidemic in Yemen is caused by astrain with an unusual antimicrobial resistance phenotype that belongs to a sublineage from South Asia.
The research highlighted particular challenges for gram-negative organisms among a population of higher-risk patients.
The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
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.