British biotechnology firm QuantuMDx last week announced an agreement with the Genome Institute of Singapore that will see the partners develop a genetic test specific to Asian populations on QuantuMDx's nanowire array-based platform.
The collaboration is an "important step" toward QuantuMDx's aim to "develop validated genetic tests for different populations worldwide," Maggie Love, business development executive at QuantuMDx, told BioArray News this week.
Love said that there was a need for such population-specific tests as "many genetic markers are identified in Western Caucasian populations and do not necessarily occur in other populations worldwide, making tests unfit" for Asian and other populations.
Established in 2008, Newcastle-based QuantuMDx develops and commercializes a number of devices capable of on-chip molecular diagnostics and sequencing. Among them is Q-POC, a handheld device that relies on sample preparation, extraction, amplification, and a nanowire biosensor to detect DNA sequences of interest in under 15 minutes, according to the firm (BAN 10/25/2011).
QuantumDX and GIS's collaboration will focus on disease-related markers discovered by GIS on Q-POC. According to a statement, the partners will design their first assay to to test patients in a cancer clinic or following surgery for the presence of the BIM deletion polymorphism, which occurs only in Asian populations. GIS has previously shown that a BIM deletion can cause a patient's malignancy to be unresponsive to the standard tyrosine kinase inhibitor treatment regime.
Should the point-of-care device identify the BIM deletion in a patient, clinicians could prescribe the use of other chemotherapuetic agents, such as BH3 mimetics, for East Asian patients with kinase-driven cancers such as chronic myeloid leukemia and epidermal growth factor receptor-mutated non-small cell lung cancer.
Axel Hillmer, a senior research scientist at GIS, described the work as "technical in nature," and focused on "establishing a point-of-care assay for the BIM polymorphism." He told BioArray News that the successful development of the BIM assay on the Q-POC platform could lead to "potential other future collaboration."
QuantuMDx is managing the collaboration via its Singapore-based subsidiary, QuantuMDx Asia, which it established last August after several years of collaboration with GIS, as well as the Singapore Institute of Manufacturing and Technology and its Institute of Micro Electronics.
QuantuMDx CEO Elaine Warburton told BioArray News this week that GIS has been "closely following" the development of Q-POC over the past two years, and has been "encouraged by the ability and flexibility" of the platform. She added that QuantuMDx and GIS have discussed a number of other assays for influenza, dengue fever, cancer, and other conditions.
Warburton said that GIS has also expressed an interest in developing QuantuMDx's Q-SEQ platform, which relies on the firm's nanowire biosensors arrayed in various different formations and structures to provide both short reads and long reads. The company envisions the clinical deployment of Q-SEQ to identify virulent and drug resistant strains of bacteria and viruses, and prescribe treatments for individuals infected with them.
According to Warburton, the collaboration with GIS is an outcome of the company's strategy to develop disease-specific panels that are "developed for and validated on populations from the geographic regions in which they are sold," adding that several other such tests are in development.
Last September, the EU awarded QuantuMDx and partners at the University of London, University of Tuebingen in Germany, and the Karolinska Institute — collectively dubbed the Nanomal consortum — €5.2 million ($7.8 million) to develop tests to detect malaria infection and drug resistance in African populations. The company is also working with partners in India to develop a pharmacogenomic test for warfarin dosing.
"We are currently conducting a trial to ensure that our warfarin assay is validated for the Indian population," said Love. "The previous studies that have identified the three SNPs responsible for determining an individuals' warfarin metabolism were conducted on a Caucasian population," she said. "Our Indo-warfarin trial will ensure that these SNPs are also relevant in a Indian population."
Eunice Teo, executive director of QMDx Asia, told BioArray News that in both cases the clinical trial data would be used to support a CE-IVD mark ahead of filing for regulatory clearance in China, India, and Singapore, which require a device to gain regulatory compliance in its home market — Europe, in QuantuMDx's case — before it can be submitted for review.
According to Warburton, the firm's Asia-specific tests will start to go into trial in 2014. She noted that the BIM polymorphism will be the first assay to undergo such scrutiny.
Once available, Love said that QuantuMDx will commercialize the tests and make them available to markets with a "real need for POC testing," such as Africa and Asia.
"We do have assays planned for European and North American populations — for example, the warfarin assay could be very useful within the UK," said Love. "However, we will be moving into these markets further down the line."