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QuantuMDx to Invest in Molecular Diagnostics Pipeline, R&D Teams Following $8.4M Funding Round

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NEW YORK (GenomeWeb) — QuantuMDx will use the proceeds from a recent financing round to optimize its handheld Q-POC molecular diagnostic device as well as several assays ahead of planned launches in 2015 and 2016. The firm is also expanding its R&D team and creating an advisory board as it prepares to shift its focus from platform development to commercialization, according to its CEO.

Elaine Warburton told BioArray News this week that the $8.4 million in recently raised funds will be used to complete the alpha prototype of Q-POC as well as alpha prototypes of disease-specific disposable cassettes. Q-POC relies on sample preparation, extraction, amplification, and a nanowire microarray to detect DNA sequences of interest in less than 15 minutes. The company is positioning the device as a durable, rapid alternative to conventional approaches used in both developing and developed countries

"Both have a need for cheap, rapid, accurate‎ molecular diagnostics with in-built sequencing that in under 15 minutes cannot only identify species but most importantly, and unlike most rapid tests on the market, drug resistance status to prescribe right first time," Warburton said on QuantuMDx's target markets. "Currently, drug resistance status is undertaken in a central lab," she said. "Imagine being able to offer complex molecular testing to everyone if the device [and] assay were able to be popped in a pocket, like Q-POC."

According to Warburton, QuantuMDx is readying a trio of "core assays" for Q-POC, all of which will become available within the next two years.

The furthest along is a test for malaria infection and drug resistance. In 2012, the EU awarded the Nanomal consortium, which includes QuantuMDx, the University of London, the Karolinska Institute, and the University of Tübingen in Germany, $7.8 million to create an assay capable of distinguishing the five malarias affecting humans as well as providing information about a patient's susceptibility to different antimalarial therapies. According to Warburton, the consortium is on track to have an assay ready for use by the middle of 2015.

QuantuMDx is preparing a second assay for warfarin sensitivity testing that it intends to launch in 2015. Though the market seems saturated by such offerings – from Nanosphere, GenMark Diagnostics, and Autogenomics to name a few – Warburton said that QuantuMDx's quick test could give it an advantage over competitors.

"Offering the genotyping test at the time of consultation, not 45 minutes or days later, and used with the validated algorithm for dosing, will enable a physician to prescribe the correct dose immediately so that warfarin can continue to be used in most countries, but without the threat of severe side effects and constant INR monitoring," she said.

QuantuMDx's third assay for tuberculosis diagnostics and drug susceptibility testing should become available in 2016, Warburton said. While there are also a number of automated molecular tests for tuberculosis on the market, among them Cepheid's xPert MTB/RIF assay, QuantuMDx aims to compete with portability, faster turnaround time, and lower costs.

Warburton said that QuantuMDx's envisioned test could be used in the field, negating the need for a central laboratory to run the assay, and should be able to provide a result within 15 minutes. The company is also aiming for an assay cost of $10 and a device cost of $1,000, well below the concessional price of $17,000 for Cepheid's GeneXpert system in developing countries.

She noted that QuantuMDx aims to obtain CE-IVD markings and US Food and Drug Administration clearance for its tests, while running field trials to establish clinical validity in other countries where there is a "pressing need for rapid, cheap molecular diagnostics."

Together, the triad will become the company's first assay menu. But as those tests inch closer to commercialization, the company is also interested in developing tests for genetic mutations associated with an increased risk of developing certain cancers with an initial focus on the BRAF and MSI genes.

"With proof of principle on these assays, we will then expand into other mutations soon after," Warburton said.

According to Warburton, by developing such a breadth of assays for use on its platform, the company hopes to obtain expertise that it can then use to add new assays or migrate collaborators' content onto its platform, a component of the firm's long-term strategy.

"We have chosen these assays as they have different sample preparation and test analysis requirements that demonstrate the versatility and flexibility of our Q-POC platform," said Warburton. "This leads in to our future business model where we partner with assay content partners to port their content on our device," she said.

Warburton said that the company should announce a number of such partnerships by the end of the year, with potential assays targeting proteins, small molecules, and nucleic acids. She said that companies with assays for influenza, Dengue fever, and HIV, as well as those with companion and pharmacogenomic tests, are at the "top of the list" when it comes to such partnerships. Warburton added that QuantuMDx is "seriously considering non-medical applications" and it has been approached by a number of interested companies to develop these kinds of tests. She did not elaborate.

'Internet of Life'

As QuantuMDx prepares its prototype device and assays for field trials, it is also entering a new "engineering phase" that will enable it to scale up production of its devices ahead of submissions to regulatory agencies in Europe and the US, according to CSO Jonathan O'Halloran.

O'Halloran told BioArray News that QuantuMDx will use some of the proceeds from its recent financing round to bring in R&D talent, including senior engineers, software engineers, and chemists. QuantuMDx is also engaging with specialist external industrial designers and product developers and is already in early discussions with manufacturers "capable of scale-up and supporting CE marking and [US Food and Drug Administration] market clearance for the device and assays," he said.

The company is also working toward a concept it refers to as the Internet of Life, according to O'Halloran. In this context, Q-POC would be used as a "biological application programming interface," where the device converts genetic codes to binary codes, "transmitting pathogenic genetic data plus GPS coordinates" into a shared network.

"Performed on a mass scale, with devices all over the world, this will enable real-time epidemiology and surveillance and early warning for emerging drug resistance, novel pathogens, and potential pandemics," said O'Halloran. He said that QuantuMDx is engaging relevant industry specialists to get the Internet of Life concept off the ground.

Along with new R&D hires, QuantuMDx intends to set up commercial, scientific, and medical advisory committees, Warburton said. "We have started to interview potential advisers and have our eye on others who we believe have the cultural fit alongside offering significant experience and guidance," she said.

According to Warburton, the new advisory board will help QuantuMDx to prepare for commercialization next year. She said that the firm anticipates carrying out a major funding round in the first half of 2015 that will allow it to "complete beta prototype development and commence commercialization in earnest."

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