Biocartis will commercialize its Idylla molecular diagnostics platform in mainland China through a 50-50 joint venture with Guangzhou Wondfo Biotech, the companies said today.

Biocartis and Wondfo said they have agreed to invest a total of €14 million ($16.2 million) of equity funding over several tranches in the joint venture, which will acquire from Biocartis a license to the Idylla platform. The funding is intended to support initial product registration, manufacturing and commercialization efforts among other activities.

Initial activities of the joint venture will focus on the local manufacturing, commercialization and registration with the Chinese Regulatory Authorities (CFDA) of the existing products in the Idylla MDx oncology test menu, including tests for colorectal and lung cancer. In a planned later phase, the joint venture is expected to develop new Idylla assays tailored to meet specific needs for the Chinese market, Biocartis and Wondfo said.

“Through our collaboration with Biocartis, Wondfo will be the first to introduce the rapid, high precision MDx testing concept into the precision medicine field in China,” Wondfo Chairman Jihua Wang said in a statement. “Additionally, with a focus on developing companion diagnostic tests, Wondfo will be able to expand its footprint to the therapeutic area and as such, close the loop.”

Launched in September 2014, Idylla is a fully-automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system designed to provide physicians with fast and easy access to individual patient biomarker data in any clinical setting at any time, in applications that include oncology as well as infectious disease and genetic tests.

According to Biocartis, Idylla covers the entire testing process from sample preparation to multiplexed real-time PCR amplification and detection within 150 minutes.

The Chinese joint venture is designed to market Idylla within oncology. The companies cited a 2016 study that detailed a rising cancer incidence in China, with over 4 million diagnosed cancer cases in 2015—of which lung cancer is the most frequent cancer type in China with 781,000 patients being diagnosed every year, according to a figure from China’s National Cancer Center (NCC) cited by Global Times, a newspaper published by People's Daily, the official newspaper of the Chinese Communist Party.

The number of targeted and immuno-oncology therapies that are prescribed based on molecular diagnostic test results is growing, with already over 500 immuno-oncology clinical trials that were ongoing in China in 2016, according to Informa Pharma Intelligence data shared by the companies.

The Chinese MDx market is one of the fastest growing in the world and expected to reach a total value of USD 1.5bn by the end of 2022, according to DataM Intelligence.

“The current size and expected growth of this market provide significant opportunities for Idylla,” whose features are an excellent fit with local market needs,” Biocartis CEO Herman Verrelst said in a statement. “The announcement today is as such a first important step in unlocking Idylla's commercial potential in China that will provide a broader cancer patient population with access to personalized medicines.”


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