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SpeeDx Preps to Launch Meningitis MDx Test in 2015, Provides Update on Partners' Plans

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NEW YORK (GenomeWeb) – Australian molecular diagnostics company SpeeDx is picking up the pace on its path to the clinic, the firm reports.

Founded on proprietary nucleic acid enzymes called MNAzymes and unique primer and isothermal signaling technologies, the company has pursued parallel paths — co-developing diagnostics with licensees and nurturing its own IVD pipeline.

Now, the company expects an undisclosed licensee to launch a CE-marked in vitro diagnostic in Q2 of 2015, and SpeeDx itself will follow with a multiplexed meningitis diagnostic later in the year. The company also published two studies of its technologies late last year and collaborated with Biocartis on cancer-related mutation detection.

Capital generated from early licensing and co-development activities funded the initial stages of the company’s internal diagnostic products pipeline development, explained Alison Todd, CSO of SpeeDx, in an email to GenomeWeb.

The SpeeDx meningitis diagnostic assay measures 10 of the most common viral and bacterial causes of the infection. It consists of four panels of multiplexed assays using SpeeDx’s patented MNAzyme multiplex detection technology and has built in extraction controls.

"The assay is being validated for use on the top three qPCR instruments already installed in pathology laboratories worldwide," Todd said, adding that this will enable labs to immediately take up the assay with no requirement to purchase any new or proprietary instruments. 

She noted that there are other meningitis assays on the market but said the majority of them only cover a small subset of the causative organisms. "For example, Cepheid sells an assay that just detects enterovirus, and this is only for use on the Cepheid proprietary platform," she said. Thus, to measure other meningitis-causing pathogens, labs must perform tissue culture, purchase multiple proprietary qPCR instruments, or develop their own tests.

"The SpeeDx panel of tests allows labs to either purchase a comprehensive panel of assays to quickly determine the causative agent, or to purchase just those panels that fill in the gaps in the menu they already have access to," Todd said.

This year, New South Wales-based SpeeDx also achieved ISO 13485 certification for design and development of in vitro medical devices to analyze human and pathogenic nucleic acids. And the company won a A$1.8 million (US$1.46 million) award from the NSW government's Medical Devices Fund to develop panels of multiplexed tests for the rapid diagnosis of human disease.

SpeeDx is a spinoff of a Sydney-based entrepreneurial subsidiary of Johnson & Johnson, J&J Research. Founded in 2009, it sought licensees in 2010, and by 2012 was shifting away from research use and driving toward diagnostics development

Its first licensee was Universal Biosensors, a firm that announced in 2011 it would use the SpeeDx technology to develop electrochemical cell-based point of care tests.

Todd said the company now has several licensees whose products are soon to enter the market, but, because of confidentiality agreements, she could not disclose their names.  However, one licensee uses MNAzymes in a product that is currently commercially available, she said. That company, Bioline Australia, sells RNA and DNA extraction control kits incorporating SpeeDx technology specific for multiplexing in lab-developed tests and also has various research-use-only pathogen detection assays in development.

Scientific studies

SpeeDx also published two scientific studies of its isothermal methods for signal amplification this year.

In August, the firm published a study in Analytical Chemistry that described an isothermal signal amplification cascade "composed entirely of inexpensive and stable DNA oligonucleotides," Todd said. This DNA-only approach "provides significant advantages in detection speed over alternative protein enzyme-free signal amplification technologies," and could be adapted to detect a range of targets — such as metal ions, small molecules, and nucleic acids. It is currently being developed for field and point-of-care applications, she said.

A second report, published in Chemical Communications in September detailed isothermal methods which "use MNAzymes to trigger the autonomous synthesis of signal-producing DNA enzymes in a target-dependent manner," Todd said. Synthesis of these DNA enzymes, or DNAzymes, uses one of two primer-activation methods "both of which are universal, hence only the target-specific MNAzyme requires alteration for each new target to be detected," she added.

Additionally, the company presented a poster at the American Association of Cancer Research annual meeting in San Diego this past April describing work done in collaboration with Biocartis.

The poster described a rapid, fully automated, multiplex assay for KRAS-BRAF mutations that used SpeeDx MNAzymes and primer assisted sequence switching, or PASS primers, on Biocartis' Idylla platform. With input of a single curl or macrodissected sample of formalin-fixed, paraffin-embedded tissue, Idylla performs FFPE pre-processing through real-time PCR in around two hours.

The poster reported specificity, sensitivity, and cross-reactivity, as well as performance on a set of 30 FFPE samples that included colon cancer and melanomas characterized using other technologies.

The reaction detected 13 KRAS mutations and five BRAF mutations in a single Idylla cartridge, and demonstrated greater than 96 percent concordance with sequencing, Todd explained. The discordant results are being "re-checked by deep sequencing to determine whether the higher sensitivity of the PASS assay has identified low-level mutations," Todd said, noting that the high specificity of the 18-plex reaction led to "significantly less cross-reactivity between mutant signals than that stated in product inserts for a singleplex Qiagen Therascreen KRAS test."

Todd further noted that the company continues to expand on the multiplexing capability of its technologies, and recently performed multiplex reactions in which 25 genes were simultaneously co-amplified and monitored using 25 unique universal probes.

Todd said ISO accreditation adds value to the quality of SpeeDx products, but is also a first step in taking a suite of IVD products to market. "Certification … helps us achieve compliance with European regulatory requirements," she said, adding, "Our quality management system has also been built to be compliant with 21 CFR 820, ensuring that we can move our products forward into the US market."

SpeeDx is continuing to develop its own molecular diagnostic assays, Todd said. It also licensed a TB marker from Tyrian Diagnostics and is also "exploring ways to bring a sensitive TB assay to the market," she said.

The company is currently seeking licensees in applied markets "such as life science research, veterinary, and agriculture," Todd said, "to fully explore and exploit the capacity of our technologies." It has no plans to license its isothermal chemistries, but is "keen to partner with companies to co-develop a simple instrument for analysis."

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