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SpeeDx Prepare for US Launch of ResistancePlus™ MG

SpeeDx
8 Dec 2017
Finn Price
Administrator / Office Personnel

Industry news

SpeeDx Pty. Ltd, a developer of advanced multiplex molecular diagnostic solutions, announced the incorporation of a US-based subsidiary company, SpeeDx Inc. The parent company, headquartered in Australia, will use the US base to support current clinical trial activity for ResistancePlus™ MG (not currently for sale in the US), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus™ MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.

ResistancePlus™ MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease. The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus™ MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR™ and ResistancePlus™ tests.

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“We have always had the goal of bringing ResistancePlus MG to the US market”, said Colin Denver, CEO of SpeeDx, “local offices and staff will allow us to more easily navigate the FDA approval process and keep us on track for our product launch next year.”

A rapid rise in resistant strains of M. genitalium across the globe has led to international guidelines for the management of M. genitalium infections that recommend testing for macrolide resistance to better inform treatment options. With M. genitalium prevalence rapidly increasing in the US, and in some instances exceeding that of Chlamydia, it is expected that US guidelines will also be updated to address antimicrobial resistance in this significant sexually transmitted disease (STD).

“Our aim is to empower clinicians and physicians to make the best treatment decisions about the diseases they are faced with,” said Colin Denver. “Ultimately, we want to support individualized patient management and better antimicrobial stewardship, which will help patients quickly receive the best treatment for their disease and for physicians to better address antibiotic resistance challenges.”

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MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.MycoplasmaBacteriaBacteria are microorganisms that play critical roles in the environment, human health, and biotechnology. Understanding bacterial genetics, growth, and metabolism is essential for developing antibiotics, vaccines, and improving industrial processes. Browse our peer-reviewed product directory to find the best bacterial research tools, compare products, check reviews, and get pricing directly from manufacturers.Clinical ChemistryClinical chemistry involves the analysis of bodily fluids, like blood and urine, to diagnose and monitor diseases. Tests in clinical chemistry provide critical information for patient care and treatment decisions. Explore clinical chemistry tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.Bacterial DetectionBacterial detection uses methods such as cell culture, microscopy, and biochemical assays to identify harmful or beneficial bacteria based on their morphological and metabolic charactersistics. These techniques support disease diagnostics, food safety, and microbial research. Explore bacterial detection systems, kits, and consumables in our directory to compare products and read reviews.

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SpeeDx Prepare for US Launch of ResistancePlus™ MG