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QuantumDx Developing Biochips for HIV, TB, and Warfarin Sensitivity Testing


By Justin Petrone

Companies that sell biochips for infectious disease and pharmacogenetic testing could have a new rival in about a year and a half. Newcastle, UK-based QuantumDx plans to debut within the next 18 months a point-of-care molecular diagnostic device that relies on nanowire arrays for target detection, according to a company official.

John Burn, medical director at the three-year-old firm, told BioArray News recently that QuantumDx has some "very 'here and now' applications in pharmacogenetics" and some "very imminent diagnostics applications in infectious disease," with longer-term research projects related to oncology.

"Once you've got infectious disease, pathology, and pharmacogenetics, the world is your oyster," he said of the firm's prospects.

QuantumDx is developing several devices that rely on nanowire-based biosensors to carry out a series of applications, including biomolecule detection, DNA extraction, and sequencing. The company's platforms will rely on technology it recently licensed as well as its own internally developed approaches.

QuantumDx earlier this month announced that it had acquired exclusive worldwide rights to Nanosys' nanotube and nanowire technology for DNA sequencing, detecting nucleic acid biomarkers associated with disease, and other applications. The agreement follows a nonexclusive licensing agreement that QuantumDx inked with Nanosys two years ago.

In exchange, Nanosys has received an upfront license fee and downstream royalty payments. No other financial details of the deal were disclosed.

According to QuantumDx, the nanowire technology "enables accurate diagnosis and quantification of multiple biomarkers using small arrays of biosensors."

The company is keen to see its devices, once developed, adopted in poorer countries for the detection of various pathogens. CEO Elaine Warburton said in a statement that the availability of such technology would "open up a whole new standard of diagnosis in third world nations" and that the company is "currently developing several low-cost assays on our hand-held point-of-care device including multi-drug-resistant infectious disease testing and companion diagnostics for accurate drug prescription."

Burn said that QuantumDx has been working with researchers in South Africa to develop point-of-care tests for HIV and drug-resistant tuberculosis. Related to its home market, the firm has ongoing projects on warfarin and aspirin sensitivity testing. The company's ultimate goal is to have a test available on its device, called Q-POC, within 18 months, he said. "We could have something by [the American Society of Human Genetics meeting] in San Francisco next November, or the year after that, but in that timeframe," said Burn.

To fund its product development, QuantumDx in August closed a financing round for an undisclosed amount from a single angel investor whom Burn declined to name. In addition, the company has won $1.2 million in research grants from the UK government to support the development of assays like its test for warfarin sensitivity. Burn said that QuantumDx's existing funds would allow it to function until next summer without seeking additional financing. The company has also received financial assistance from Newcastle University, which has also provided QuantumDx with facilities.

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Any one of these tests will put QuantumDx up against a host of competitors. Companies such as GenMark Diagnostics and Autogenomics offer array-based tests for CYP2C19 variants associated with warfarin sensitivity, both of which already have US Food and Drug Administration clearance. Other companies with array and chip-based technology platforms, such as CapitalBio and Akonni Biosystems, have TB tests in either on the market or in development.

Burn said that QuantumDx's advantage in the market stems from the potentially quick turnaround time of its assay, as well an anticipated low cost per chip, which he said could be priced anywhere from $1 per chip to $20, based on the volume manufactured.

"If we can get these polymorphisms onto a chip, and we can offer 20-minute testing in the warfarin clinic, that is a nice proof-of-principle of real-time pharmacogenetics." He also speculated that the technology could find use in other applications. "We can turn to pharmaceutical companies and say, 'If you have drugs that require companion diagnostics, you can sell this device with your drug."

Another area of interest is forensics, where firms like Illumina that sell genotyping arrays are already gaining some market share.

Another advantage of the system over current technologies is its ability to directly detect biomolecules using its nanowire arrays, said Burn. "If you can connect a biomolecule — DNA or RNA — to this chip and every time a letter comes up the computer reads it, there are no middle men, no fussy lights, no camera detection systems, you can't get any simpler than that," he said. "This has got to be the dominant technology in terms of genotyping and sequencing."

Burn said the firm is currently determining the throughput of its technology, but said it was possible that its nanowire arrays could contain "thousands" of probe sites.

In addition to Q-POC, QuantumDx is developing a DNA extraction and fractionation chip based on its own technology, which it intends to position as a sample preparation tool for next-generation sequencing applications. The firm is also developing a DNA sequencing device called Q-SEQ that relies on nanowire biosensors arrayed in various formations and structures to provide both short reads and long reads.

"Shotgun sequencing, which is the only NGS method presently available, cannot provide the full story of variation, as it is unable to resolve copy number variations, large repeats, and rearrangements," the firm maintains on its website. "A combination of shotgun and targeted long-read-length sequencing will facilitate the definitive de novo sequencing platform and deliver true whole-genome sequencing, not the 70 percent genome sequencing that shotgun platforms presently offer," it claims.

Burn declined to provide a timeline for when the firm's Q-SEQ platform could become available.

Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com