Laboratory

Partnership for molecular diagnostic test

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.”

 

Source: SpeeDx

25.04.2017

Read all latest stories

Related articles

Photo

Sponsored • Addressing a broad range of research applications

Mass spectrometry advances

Since the Covid-19 epidemic took hold, the public has expected ‘unprecedented progress from the scientific community,’ observed Dan Shine, senior vice president and president of the analytical…

Photo

Sponsored • Liquid chromatography/mass spectrometry

LC-MS: Calling for easy-to-use platforms

Liquid chromatography/mass spectrometry (LC-MS) is an established powerful tool in routine clinical use and clinical research. However, to further capitalise on its benefits, instrument and…

Photo

Sponsored • Testing technology

Vitamin D testing: LC-MS outperforms immunoassays

In recent years, clinicians have increasingly focused on vitamin D deficiency. Studies show that previous reference values – particularly for Vitamin D3 – were most probably set too high. Liquid…

Related products

Siemens Healthineers – Fast Track Real-time PCR assays

Infectious Disease

Siemens Healthineers – Fast Track Real-time PCR assays

Siemens Healthineers
Image Information Systems – iQ-View

Reading

Image Information Systems – iQ-View

IMAGE Information Systems Europe GmbH
MolGen – PurePrep 96

Extraction

MolGen – PurePrep 96

MolGen
Nova Biomedical – StatStrip Glucose/Ketone*

Blood Glucose

Nova Biomedical – StatStrip Glucose/Ketone*

Nova Biomedical Corporation
Sarstedt - COVID-19 virus diagnostics products

Saliva Collection

Sarstedt - COVID-19 virus diagnostics products

SARSTEDT AG & CO. KG
Sarstedt – CSF false-bottom tube

CSF and Alzheimer’s Disease Diagnostics

Sarstedt – CSF false-bottom tube

SARSTEDT AG & CO. KG
Subscribe to Newsletter