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MiRxes Rolls out Gastric Cancer qPCR Dx in Europe; Expands Operations to US, Asia

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NEW YORK (GenomeWeb) – MiRxes, a Singapore-based life sciences and molecular diagnostics company, has expanded its global activities in recent weeks obtaining a CE-IVD mark for a quantitative PCR-based gastric cancer test, while establishing a US subsidiary and naming distributors to sell its products across Europe, the Middle East, and Asia.

Ray Ong, the company's head of business development, said that MiRxes has enjoyed increasing support from cancer researchers in Singapore and has taken part in projects with local pharmaceutical companies, the success of which has encouraged the firm to now expand abroad.

"Over the last two years … we have secured a good share of the local microRNA technology market, and we have to expand to the global arena in order to continue this growth," Ong said.

MiRxes commenced operations in 2014 when it launched its mSMRT-qPCR platform, which enables users to identify circulating miRNA biomarkers using existing qPCR workflows. The approach has been seen by some as an ideal method for detecting the molecules, given their limited length of 18 to 22 base pairs. The company is privately held, and employs 30 staffers at its Singapore headquarters, Ong said, though it plans to increase headcount in the coming year.

One of its new target markets is Europe, where GastroClear, the company's gastric cancer kit, gained regulatory clearance earlier this month. MiRxes markets GastroClear as a molecular screening test for early-stage disease, claiming that its assay can detect Stage I gastric cancer in a blood sample by measuring multiple miRNA biomarkers. The company validated its test on Thermo Fisher Scientific's QuantStudio Dx Real-Time Instrument, but the assay will work on any RT-PCR system.

GastroClear generates a risk score that is used to stratify patients into three categories: high, intermediate, and low risk Those whose score places them in the high risk category are considered to be at a greater risk of developing gastric cancer and are recommended to follow up with gastroscopy, biopsy, or both, according to the firm.

Ong said that gaining a CE-IVD mark for GastroClear in Europe is just a component of its plan to introduce its tests and services to that market. The company recently attended the trade conference Medica in Düsseldorf, Germany, to promote GastroClear, as well as the company's various research-use products, such as its Ideal miRNA panels for cancer, stem cell, and biofluid work, and its human, mouse, and rat qPCR miRNA assays. MiRxes has also launched a new qPCR kit called BlitzAmp that it claims can be used in a variety of applications, including DNA cloning, gene cloning, functional analysis of genes, and hereditary disease diagnosis and monitoring.

MiRxes has also recently tapped Madrid-based Laboratorios Conda to represent its products in Spain, while Euroclone, a biomedical company located near Milan, will introduce MiRxes' offerings to the Italian market. Ong said that MiRxes is interested in working with other European partners, and could even consider setting up a European subsidiary if enough projects emerge.

GastroClear's European clearance will also make it accessible to clinicians in some Asian markets that recognize the CE-IVD mark, such as Vietnam, where Ho Chi Minh City-based United Scientific has agreed to distribute MiRxes' products.

According to Ong, while gaining a CE-IVD mark is certainly a milestone for the firm in Europe, a larger market awaits the test in Asia, which leads the world in gastric cancer cases. According to a 2012 World Health Organization study, the five countries with the highest incidence of the disease were, in order, Korea, Mongolia, Japan, Guatemala, and China.

Given this need, the company is working with the Singapore Gastric Cancer Consortium, A*STAR Diagnostics Development Hub, and major hospitals in Singapore to expand its clinical studies, with the aim of obtaining local regulatory clearance from the Singapore Health Sciences Authority for the test by the end of 2018.

"The current healthcare system in Asia has a strong demand for [an] early diagnostic in gastric cancer," said Ong. "We seek to complement and furnish physicians with additional tools to [provide] a more accurate clinical decision," he said. Ong characterized the uptake of the test as "community- and market-driven," and said that the company is working with partners in Malaysia, Japan, and Korea to undertake clinical studies of the test. In the next 12 months, GastroClear will undergo multi-center clinical studies with a combined 10,000 control and cases in Asia, he said.

The company has also added distributors in several Asian markets recently, working with Sagang in Seoul, Korea; SM Chemical Supplies in Bangkok,Thailand; Genomics, a Taiwanese firm; Biomed Global in Kuala, Lumpur, Malaysia; and Premas Life Sciences in New Delhi, India. MiRxes also has announced an agreement with Sakhan in Tehran, Iran, to distribute its products in the Middle East.

In most Asian markets, MiRxes sees GastroClear as the assay that will drive its business abroad. By offering Asian customers the opportunity to get an answer on their risk for developing the common cancer by taking a blood-based test, rather than undergo an endoscopy, the company believes its test will allow clinicians to catch the disease at an earlier stage in more people.

"Today, in high-prevalence countries such as South Korea and Japan, the compliance rate for routine screening sits at 20 percent to 30 percent, although it is heavily subsided by the local healthcare systems," noted Ong. "It is clear that the deterrence to go through gastro-endoscope is high ... largely due the discomfort of the procedure and in [some] regions the lack of the infrastructure." MiRxes' test "reduces discomfort and allows scalability across key testing labs," Ong said.

China is certainly an attractive market for the test. MiRxes formed a subsidiary in Hangzhou last year to handle its relationships with local users. According to Ong, MiRxes' Chinese facility currently employs 10 people who, in particular, are working with multiple local hospitals to validate GastroClear and other assays. He said that MiRxes is interested in finding a partner in China to manage the distribution of its products and services across the country.

The company is also moving ahead in validating a lung cancer test with its Chinese partners, hoping that its focus on detecting early-stage lung cancer will distinguish its platform in the market. Lung cancer is the leading cancer in China. By the end of the decade, the government has forecast roughly 800,000 new diagnoses per year, and a corresponding number of deaths.

"Lung cancer is an epidemic in China, and this will be a key driver for the Chinese market," Ong said.

MiRxes believes that the breast cancer assay it is developing might allow it to gain traction in the US in a similar manner. The company established a subsidiary in Boston just weeks ago in partnership with Harvard Lab. Ong noted that Frank Slack, director of the Institute for RNA Medicine at Beth Israel Deaconess Medical Center, sits on MiRxes' scientific advisory board.

He added that the US subsidiary will act as a core facility as well as a sales and support service for the company's US customers, though it is still seeking a distributor in the US. Over the next year, MiRxes hopes to have about five people supporting its core facility in Boston, Ong said.

MiRxes hopes to gain CE-IVD marks for its breast and lung cancer tests in 2018. However, the company's regulatory plans for the US, as well as for Japan, which has a similar degree of medical device oversight, remain unclear for now. A new round of financing is more apparent. Ong said that MiRxes will aim to carry out a Series B raise of financing over the next two years.