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Point-of-Care Malaria MDx Project Funded by EU and Using QuantuMDx Technology is Ahead of Schedule


Nanomal, a European Union-funded public-private consortium developing a handheld device for rapid, point-of-care molecular diagnosis of malaria and drug resistance, said this week that the instrument is a year ahead of schedule and will be ready for field testing later this year.

It is anticipated that the device, once completed, will be able to analyze DNA from a patient's finger-prick blood sample and provide a malaria diagnosis, speciation, and drug resistance information in just 15 minutes at a cost of approximately £10 ($13) per test, enabling the administration of more effective drug combinations at the point of care, the consortium said.

In addition, the device is based on the same microfluidic PCR and nanowire array technology that underlies Q-POC — a handheld, cassette-based molecular testing device being developed by consortium partner QuantuMDx. As such, successful testing and implementation of the Nanomal device could be a boon for QMDx as it prepares Q-POC for commercialization.

Q-POC's development goes "hand in hand" with that of the Nanomal device, Maggie Love, a business development executive at QMDx, told PCR Insider in an email this week, adding that the Nanomal malaria test "will be one of many different test cassettes" that will run on the Q-POC device."

Founded in 2008, Newcastle, UK-based QMDx in 2009 non-exclusively licensed IP from Harvard spinout Nanosys covering the use of nanowire sensing technology in DNA sequencing and biomarker detection — a license it expanded in 2011 in order to incorporate the technology into the Q-POC system (PCR Insider, 10/13/2011).

Meantime, QMDx developed in house several molecular biology, chemistry, and microfludic technologies for the Q-POC system, including a rapid DNA extraction technology based on sorbent filters and microfluidics, a DNA fractionation method, and a continuous flow PCR method.

Parallel to Q-POC's development, QMDx began sniffing out application areas for the device, homing in on infectious disease and cancer testing.

In November of last year, the company said that it was heading a UK-based £2.8 million ($4.3 million), three-year public-private partnership to develop a version of Q-POC called Q-Cancer for diagnosing and staging cancer, and potentially guiding oncology treatments (PCR Insider, 11/8/2012).

Also, in September, QMDx announced its participation in the Nanomal consortium, which is being funded by the European Commission's Seventh Framework Programme to the tune of €5.2 million and is being led by researchers at St. George's University of London with contributions from the University of Tübingen in Germany and the Karolinska Institute in Sweden.

This week, the consortium and QMDx noted that development of the malaria test is about a year ahead of schedule, and that the device will be ready for field testing later this year — about the same development phase at which the Q-POC device finds itself.

QMDx "now has its first benchtop sample-to-result prototype device," QMDx's Love said. "This breadboard contains the novel sample preparation, DNA extraction, amplification, and detection technologies that QMDx has been developing for the past five years. Now, for the first time, these technologies are integrated within one device, allowing the scientific team to optimize not only each individual technology but the entire process."

For the malaria test, "no modification of the Q-POC device will have to be made; just further development to integrate all the technologies and chemistries," Jonathan O'Halloran, chief scientific officer at QMDx, told PCR Insider in an email.

"The sample prep technology is unique in that, following a rapid mechanical lysis, a whole sample simply flows through a special filter that removes all non-nucleic acid blood constituents in under three minutes," O'Halloran said.

This purified DNA eluate then rehydrates lyophilized PCR reagents and is flowed through different temperature zones for rapid thermal cycling, and the device's continuous flow PCR cycler can perform 30 cycles in less than four minutes.

"These amplicons then simply flow into the nanowire array channel," O'Halloran said. "Therefore, the sample follows one single microfluidic channel, making the fluidics extremely simple, robust, and reproducible."

The importance of a rapid point-of-care molecular testing system for malaria and drug resistance is supported by recent research suggesting that current artemisinin combination therapies could eventually become obsolete, something that has already happened with other anti-malarial drugs.

"With the emergence of drug resistance over the past decade we are beginning to understand that simply providing a rapid diagnostic at the point of care is no longer enough to effectively manage infectious disease," O'Halloran said. "All too often, the standard treatment prescribed turns out to be ineffective as the infecting pathogen has acquired resistance to the first-line drugs. This is a waste of time and money, and more importantly a risk to the patients' well-being."

The Nanomal group will initially use well-vetted drug resistance genes for its assay. Many such genes have been identified in culture-based experiments and have also been used to predict treatment failures in patients who receive particular drugs, Sanjeev Krishna, Nanomal project leader and a professor at St. George's London, said in an e-mail to PCR Insider.

"The simple-to-use, handheld Nanomal device will bring complex drug resistance analysis to the remotest areas, where malaria often goes undetected because of the lack of facilities," Krishna added. "There is also great value in being able to collect drug resistance information from parasites and for that information to become centrally available through communication technologies, so that drug resistance markers can be assessed in a community and eventually nationally and internationally."

Love said that the consortium is developing the Q-POC malaria assay for use by relatively untrained healthcare workers in resource-scarce settings. "The user simply needs to take the sample, input it into the device, press a few buttons, and read the result," she said.

The group noted that the device aims to provide the same quality of result as a reference laboratory at a fraction of the time and cost. Each device is expected to cost about the same as a smartphone but may eventually be distributed free in developing countries. A single-test cartridge is expected to cost around $13 initially, with the goal of reducing this cost to ensure affordability in resource-limited settings.

The Nanomal group will conduct field trials in Gabon, where Nanomal partner Peter Kremsner, a professor at Eberhard Karls Universität in Tübingen, also serves as director of the Albert Schweitzer Hospital. Kremsner has "extensive experience" leading studies that have been pivotal to the registration of new anti-malarial drugs and combination therapies, and the Albert Schweitzer Hospital is a leading site for malaria vaccine trials, Love noted.

QMDx owns all commercial rights to the Nanomal project assay. It is unclear what other infectious disease assays QMDx is developing for Q-POC, but it originally cited sexually transmitted infections and drug-resistant tuberculosis as possibilities.

Meantime, development of the device for cancer testing, both through the Q-Cancer project and internally at QMDx, is ongoing.

"This device is being further developed to process [formalin-fixed, paraffin-embedded] and fresh tumor tissue specifically for the Q-Cancer project," O'Halloran said. "Furthermore, QMDx is presently developing molecular assays for a range of important markers for different cancers."