SelectScience
Join Free
NewsLife Sciences

SpeeDx and Thermo Fisher Scientific Announce Strategic Partnership for FDA Clearance of Molecular Diagnostic Test

The new test would bring disease and antibiotic resistance testing for potential “superbug”

24 Apr 2017
Mo Aly
Marketing / Sales

Product news

SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed an agreement with Thermo Fisher Scientific, the world leader in serving science. The announcement was made at the 27th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna to submit its ResistancePlus™ MG Test for the detection of Mycoplasma genitalium to the US Food & Drug Administration (FDA).

Following ongoing validity, SpeeDx will submit the test for use with the Applied Biosystems 7500 Fast Dx Real-Time PCR System. The ResistancePlus™ MG Test is designed to identify both M. genitalium and mutations in the 23S rRNA gene of the bacteria that have been shown to confer resistance to azithromycin, a commonly prescribed macrolide-based antibiotic. The test has previously received a CE mark, accreditation by the Australian Therapeutic Goods Administration (TGA), and is already marketed across Europe, Australia and New Zealand.

“We developed this diagnostic test to address an immediate need for detection and resistance screening for this difficult to manage STI,” said Colin Denver, CEO of SpeeDx. “With its reputation for scientific excellence, we are very pleased to partner with Thermo Fisher to bring this test to the US market. Applied Biosystems qPCR instrumentation has a long-standing reputation for quality, and a wide install base across the region.”

”We are proud to be partnering with SpeeDx to enable them to bring their diagnostic test to the U.S. market,” said Kim Kelderman, vice president and general manager, Genetic Analysis, at Thermo Fisher Scientific. “We are committed to working with diagnostic partners around the world who share our vision of driving better health outcomes by using precision medicine.”

For more information on this announcement, please visit the SpeeDx (#97) and Thermo Fisher (#83) booths at ECCMID April 22-27.

Tags

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 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.qPCRQuantitative PCR (qPCR) is a molecular biology technique used to amplify and measure the amount of a specific DNA or RNA target. It plays a crucial role in gene expression analysis, pathogen detection, and quantifying DNA or RNA in various applications. Real-time PCR provides precise, quantitative results and is widely used in research, diagnostics, and clinical studies. Browse our peer-reviewed product directory to find the best qPCR solutions; compare products, check reviews, and get pricing directly from manufacturers.BacteriaBacteria 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.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.AntibioticsAntibiotics are substances that kill or inhibit the growth of microorganisms, such as bacteria and fungi. They are essential in the treatment of infections and in preventing disease spread. Explore antibiotics research and diagnostic tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.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.Antibiotic ResistanceAntibiotic resistance poses a significant threat to public health driving innovation and change through antibiotic stewardship efforts. Ongoing research and diagnostic efforts focus on new treatments and detection methods. Explore antibiotic resistance research and diagnostic tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Precision MedicinePrecision medicine refers to the idea of customized healthcare, where medical decisions and treatments are tailored to the individual patient. Molecular diagnostics, companion diagnostics and Next Generation Sequencing (NGS) play a pivotal role in this approach.

Related articles

SpeeDx and Thermo Fisher Scientific Announce Strategic Partnership for FDA Clearance of Molecular Diagnostic Test