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FDA Grant Breakthrough Designation for ResistancePlus® GC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Designation for ResistancePlus® GC – expediting the path towards clearance. …
Continue ReadingPlexPCR® RespiVirus receives TGA clearance for sale in Australia
PlexPCR® RespiVirus received clearance from the Australian Therapeutic Goods Administration (TGA), bringing much needed workflow advantages in time for the …
Continue ReadingStudy gauges impact of genotyping on gonorrhea treatment
Dr. Klausner, a clinical professor at UCLA, shares the details of his work with genotypic testing for ciprofloxacin susceptibility in …
Continue ReadingSpeeDx Close Series A Fundraising With Support From U.S. Venture Firm
SpeeDx announced further series A funding received by new investor partners, Northpond Ventures, LP – a U.S.-based, formative stage venture …
Continue ReadingSpeeDx and Cepheid announce test partnership
SpeeDx Pty, Ltd. announced an agreement with Cepheid to manufacture their market-leading ResistancePlus® tests for use on the GeneXpert System. …
Continue ReadingSpeeDx trusted assay partner for Cepheid FleXible for the GeneXpert program
ResistancePlus® MG will be the first test available through Cepheid’s FleXible cartridge program. This partnership will increase access for clinicians …
Continue ReadingSpeeDx new US Headquarters
SpeeDx have successfully settled into new U.S. Headquarters at the Texas Health CoLab in Austin Texas. Chosen for its synergy …
Continue ReadingSpeeDx sign Middle East Distributor
New distribution partners, Al Zahrawi Medical Supplies LLC, will distribute SpeeDx ResistancePlus® and PlexPCR® tests across UAE, Saudi Arabia, Oman, …
Continue ReadingTGA clearance for ResistancePlus® GC
ResistancePlus® GC received clearance from the Australian Therapeutic Goods Administration (TGA) today. Launched in December with CE-IVD mark for sale …
Continue ReadingSpeeDx Develops Multiplex Test for Respiratory Viruses
SpeeDx announced submission of the PlexPCR® RespiVirus test to the Therapeutic Goods Administration (TGA), with anticipated clearance in time for …
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