Biocartis and A*STAR’s ETPL initiate development of breast cancer assay to guide therapy selection

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Singapore's Agency for Science, Technology and Research will develop the new assay while Biocartis will be responsible for commercialisation.

Molecular cancer diagnostics specialist Biocartis has announced that it has extended its partnership with ETPL (the commercialization arm of A*STAR, Singapore’s Agency for Science, Technology and Research) with a new five-year strategic partnership, focused on the development of molecular diagnostic assays for Biocartis’ Idylla platform, a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample. The first assay selected for development under the partnership is a fully automated solid biopsy assay, aimed at supporting optimal therapy selection decisions for breast cancer patients.

Under the terms of the agreement, parties will co-invest in the development of jointly selected tests. For each selected test, Biocartis will be responsible for the commercialization of the tests under its own label, while ETPL will act as a development partner through Singapore’s Diagnostics Development (DxD) Hub. Financial details of the partnership are not disclosed.

The first assay selected for development under the new partnership is a fully automated solid biopsy assay, operating directly from FFPE tumor tissue and aimed at supporting optimal therapy selection for Her2-targeted therapies, hormone receptor therapies, as well as some novel targets for breast cancer patients.

Breast cancer is the most common cancer among women worldwide and the largest segment of the cancer diagnostics market, expected to account for USD 13.1bn by 2020. Current breast cancer diagnostic testing methods comprise complex and lengthy workflows, involving numerous manual steps and visual interpretation of results. Consequently, specificity and reproducibility of these test methods are challenging with both false positive and false negative test results occurring commonly. Also, as today’s methods require specific laboratory expertise and samples need to be shipped for such analyses, it often takes a long time before results are available.

Furthermore, an increasing number of targeted and hormone therapies for breast cancer drives the demand for assays that guide therapy selection. Among other biomarkers, the assay will include Her2, which is a major prognostic biomarker shown to occur in 18-20% of breast cancers and which is currently recommended for the evaluation of primary invasive breast cancer. Hormone receptor therapy, which has the potential to be used in about two-thirds of women with breast cancer tumors that show hormone receptor expression, is currently part of the routine tumor characterization process.

Being Biocartis’ second assay in the breast cancer segment and an important addition to Biocartis’ menu of tests next to its current focus on melanoma, lung and colorectal cancer, the assay has the potential to enable fast and robust results and as such, make a real difference with current testing methods.

Geert Maertens, Chief Scientific Officer of Biocartis, commented: “By combining the expertise and network of ETPL and Biocartis, this partnership agreement has laid the foundation to bring more high performing Idylla assays to the market in a shorter timeframe. We are thrilled to work with ETPL for the development of our second breast cancer assay, this time aimed at supporting decisions for a rapidly growing number of targeted and hormone receptor therapies for breast cancer patients.”

Sidney Yee, CEO of the DxD Hub, and Executive Vice-President of ETPL, said: “We are pleased to announce today an extension of our partnership with Biocartis, a global player in molecular diagnostics at the forefront of innovation. Over the years, Singapore’s investment in research and development has established a strong base of technological capabilities and produced a pipeline of cancer biomarkers. ETPL’s partnership with Biocartis is an excellent opportunity for us to accelerate the creation of diagnostics innovations that will serve the growing needs for early diagnosis of cancer, better patient monitoring and care, and lower health care costs.”

The extended agreement fits well with Biocartis’ strategy to accelerate the expansion of its menu of molecular diagnostic tests through third party partnerships, and aligns with Singapore’s vision to develop globally competitive products and grow the local diagnostics ecosystem.