SpeeDx

About

SpeeDx develops multiplex qPCR-based molecular diagnostic assays and point-of-care tests for sexually transmitted infections, antibiotic-resistance markers, and respiratory disease, using patented InSignia gene-expression technology.

Mission

SpeeDx develops molecular diagnostic solutions that deliver multiplex detection and information to improve patient management, driven by real-time qPCR technology and priming strategies. The company focuses its product portfolio on STIs, antibiotic resistance markers, and respiratory disease and has recently patented an InSignia™ technology. SpeeDx plans to use CARB‑X funding to develop an affordable, fast (<60 minutes) point‑of‑care test that detects Chlamydia trachomatis and Neisseria gonorrhoeae while identifying gonorrhea antimicrobial resistance to cefixime, ciprofloxacin, and azithromycin. The company is collaborating with QuantuMDx to port the assay onto QuantuMDx’s Q‑POC™ battery-powered qPCR and integrated microarray device for use in remote or resource-limited settings. SpeeDx was founded in 2009, is a private Australian company, and maintains subsidiary offices in Austin and London with distributors across Europe. SpeeDx develops innovative molecular diagnostic solutions built on real-time polymerase chain reaction (qPCR) technology and patented InSigniaTM gene-expression measurement. Its product portfolio focuses on multiplex diagnostics for sexually transmitted infections, antibiotic-resistance markers, and respiratory disease. The company is adapting a Nepean Hospital laboratory test that targets a genetic marker correlated with respiratory virus infection and disease progression. SpeeDx plans to commercialize a rapid, high-throughput respiratory virus host‑response assay to support risk-based patient stratification for COVID-19 management and future pandemic preparedness. The commercial test will leverage newly patented InSigniaTM technology to enhance gene-expression measurement. SpeeDx was founded in 2009 and is Australian-based with subsidiary offices in Austin and London and distributors across Europe. The company was recently awarded grant funding through the MTPConnect Biomedical Translation Bridge program to support commercialisation timelines. SpeeDx develops molecular diagnostic tests for infectious diseases that provide both identification and therapeutic guidance, with product focus on STIs, antibiotic resistance markers, and respiratory disease. Its flagship product, ResistancePlus MG, detects Mycoplasma genitalium and genetic markers of macrolide resistance and is being finalized in U.S. clinical trials. ResistancePlus MG was also developed on the GeneXpert® platform in partnership with Cepheid and launched in late 2019 in Australia, New Zealand, and parts of Europe. Pre-clinical work is wrapping up for ResistancePlus GC, a ciprofloxacin-susceptibility test for gonorrhoea that has received FDA Breakthrough Device designation to fast-track registration. The company said the new capital will support structural and process investments to enable pipeline and service growth as it expands its global footprint. SpeeDx is based in Australia with offices in Austin and London and distributors across Europe. SpeeDx develops molecular diagnostic tests—principally multiplex qPCR assays—that provide identification and therapeutic guidance for infectious diseases and antibiotic resistance. Its product portfolio includes ResistancePlus MG for Mycoplasma genitalium and ResistancePlus GC for gonorrhea, the latter granted FDA Breakthrough Device designation. The company has partnerships with GlaxoSmithKline for antibiotic development and with Cepheid to run a SpeeDx test on the GeneXpert platform. Clinical studies in the U.S. for ResistancePlus MG are nearing completion, with FDA submission likely before the end of 2019, and commercial scale-up is a stated near-term priority. SpeeDx is based in Australia with offices in Austin and London and distributors across Europe. The company is positioning its technology for broader global deployment where rapid, actionable treatment information is needed.

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