Biocartis and Wondfo announce joint venture for commercialization of Idylla platform in China

Biocartis NV, an innovative molecular diagnostics company, and Guangzhou Wondfo Biotech, a fast growing diagnostics player in China, announce entering into a joint venture aimed at the commercialization of the fully automated molecular diagnostics (MDx) Idylla™ platform in mainland China, within the field of oncology.

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. This market growth is driven by, amongst others, 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 close to 800,000 patients being diagnosed every year. Due to the rising cancer incidence, 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.

Biocartis Yole

Giving the increasing market demand for fast, high performing and cost effective MDx testing, the fully automated, real-time PCR-based MDx Idylla™ platform is expected to provide Chinese laboratories and hospitals with a unique solution allowing for fast and easy access to molecular biomarker information, covering the entire process from sample to result within 150 minutes. Moreover, the Idylla™ platform can analyze both RNA and DNA and can directly process, with less than two minutes hands-on time, both solid and liquid biopsy sample types, including FFPE (formalin-fixed paraffin embedded) tumor samples.

The initial activities of the joint venture are focused on the local manufacturing, commercialization and registration with the Chinese Regulatory Authorities (CFDA) of the existing products in the Idylla™ MDx oncology test menu for amongst others colorectal and lung cancer. Furthermore, in a next phase, the joint venture is expected to develop new Idylla™ assays tailored to meet specific needs for the Chinese market.

The joint venture will be 50% owned by Biocartis and 50% owned by Wondfo. In order to fund amongst others the initial product registration, manufacturing and commercialization efforts of the joint venture, both parties will, over several tranches, provide a total of EUR 14m of equity funding. The joint venture will acquire from Biocartis a license to the Idylla™ platform.

Herman Verrelst, Chief Executive Officer at Biocartis, commented: “We are proud and honored to announce our strategic collaboration with Wondfo for the Chinese market. With Wondfo, we team up with a partner that has deep knowledge and experience of the Chinese diagnostics market. The current size and expected growth of this market provide significant opportunities for Idylla™, whose features are an excellent fit with local market needs. Furthermore, we see great interest from pharma and test content partners to extend existing collaborations into China. The announcement 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.

Mrs. Jihua Wang, chairman of the board at Wondfo, added: “We are honored to announce our strategic collaboration with Biocartis. The Idylla™ technology and how it enables access to revolutionary personalized medicine already improved so many lives of cancer patients. We believe that thanks to the use of molecular diagnostics enabling innovative targeted therapies, one day, cancer might be treatable like a chronic disease. 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. 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. We sincerely hope that thanks to this collaboration and our joint efforts as diagnostic companies, patients and patient communities in China will soon be able to benefit from the advanced Idylla™ technology.

The closing of the collaboration between Biocartis and Wondfo is subject to certain customary closing conditions. It is expected that the joint venture will launch its operational activities towards the end of 2018.