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With Handheld Test Device Prototype Ready, QuantuMDx Seeks Financing to Support Commercial Launch

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NEW YORK (GenomeWeb) – QuantuMDx, a Newcastle, UK-based molecular diagnostics company, last week announced that it had successfully completed the development of its Q-POC handheld testing device.

Q-POC is a microfluidic cassette that is inserted into a handheld reader and enables users to obtain the results of microarray-based assays for pathogen identification and associated drug resistance within 15 minutes. QuantuMDx is positioning the device for use in both developing and developed countries.

CEO Elaine Warburton told BioArray News in an email this week that the completion of the Q-POC prototype is of "great importance" for QuantuMDx as it prepares to launch multiple assays on the system over the next few years.

"It clearly demonstrates that our technology works and the significant barriers associated with integration have been overcome," Warburton said. It also "heralds a change within QuantuMDx" as the firm transitions from being an R&D company to a commercially focused company, she said.

Warburton also said that QuantuMDx will over the next few months initiate a series C investment round and seek partners to help bring its device and tests to market.

QuantuMDx most recently completed a series B round in June for $8.4 million.

Warburton said the new round will be used for "major infrastructure expansion" and commercialization. "We are only a small company and so partnering is a great way for us to expedite development, trials, and commercialization," she said. "But we cannot partner without offering a working prototype."

Founded in 2008, QuantuMDx has spent the last half decade preparing Q-POC and an initial menu of tests for launch. The handheld device integrates preparation of a variety of sample types, including blood, sputum, and fresh and formalin-fixed, paraffin-embedded tissues, with PCR amplification and detection via a nanowire biosensor microarray within a single microfluidic cassette. According to Warburton, QuantuMDx anticipates that assays could cost between $5 and $20 per test depending on complexity.

Creating such a device, though, has taken "years of dedicated research," not only to miniaturize complex molecular assays within a cassette, but to establish "sufficient redundancy and flexibility to run many different tests. Given Q-POC's reliance on multiplex PCR and microarray detection, Warburton characterized the firm's development program as "fraught with technical risk" at all stages of the integration process.

"Perhaps the hardest challenge has been in ensuring that all the different chemistries required for lysis, extraction, PCR, and hybridization, work together and, importantly, within the 15 minute to 20 minute target time period," she said.

QuantuMDx currently has three tests in different stages of development for Q-POC: an assay for malaria infection and drug resistance; a test for warfarin sensitivity; and a tuberculosis diagnostic that will also offer information on drug susceptibility.

Of the trio, Warburton described the company's warfarin test as "more advanced" and said that QuantuMDx is performing internal trials on a retrospective sample library. The company is positioning the test as a quicker, less expensive option for labs than competing array-based offerings from the likes of Nanosphere, GenMark Diagnostics, and Autogenomics, among others.

In regards to its malaria and TB assays, Warburton said that QuantuMDx has been working with academic and clinical partners to test primer and probe pairs in standard PCR and microarray formats on cultured libraries that represent all the species and sub-types of the infectious pathogens, as well as drug resistance strains.

"This again has been a huge challenge and represents an extremely important body of work that we look forward to sharing in the upcoming years," said Warburton. "We have now locked down both assays in terms of primer and probe sites and are presently translating these assays to our prototype device," she said.

QuantuMDx aims to obtain CE-IVD markings and US Food and Drug Administration clearance for its tests, and plans to have the device on the market for clinical use sometime in 2016, according to Warburton.

As it moves ahead with device and assay development, QuantuMDx continues to advance its Internet of Life concept. CSO Jonathan Halloran previously described the Internet of Life to BioArray News as a "biological application programming interface" centered on the Q-POC, where the device converts genetic codes to binary codes and transmits pathogenic genetic data plus global positioning system coordinates into a shared network.

According to O'Halloran, the company envisions that data collected from Q-POC devices around the world will constitute an early warning system that will enable the prevention of pandemics, as well as the containment and management of drug resistance.

"This concept has caught the attention and sparked the imagination of many," O'Halloran said of the Internet of Life this week. "With the horrors of the Ebola outbreak and the World Health Organization warning of the devastating potential impact of antimicrobial resistance, many more now understand the massive importance of an advanced monitoring system," he said.

Since its most recent financing in June, QuantuMDx has "seen a lot of development" toward realizing the concept, O'Halloran noted. He said the company is working with a large partner to define the security, data transfer, cloud-based architecture, and protocols required for this vision of integrated and networked population diagnostics. He declined to name the partner.

O'Halloran said that QuantuMDx is designing a trial of the Internet of Life concept that will take place toward the end of 2015 in Gabon, on the west coast of Central Africa.

"We wish to test both the personalized medicine aspect of the Q-POC ... as well as to test the connectivity and security protocols of sending the anonymized and geo-stamped data to a central data base for real-time epidemiological analytics," O'Halloran said.

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