Increase in collaborations between key diagnostics manufacturers and pharmaceutical companies for the development of effective solutions to circumvent cancer management related challenges is driving the oncology companion diagnostics market. For instance, in January 2016, NanoString Technologies, Inc. signed an agreement with Astellas and Medivation to modify its PAM50-based Prosigna Breast Cancer Assay for use of this test as a potential CDx test with enzalutamide, a drug used to treat triple negative breast malignancy.
The use of companion diagnostics for oncology- clinical trials is rapidly increasing, as it offers several significant advantages, such as reduction in trial size and improvement in the success rate of different clinical trials. In addition, rising R&D investments in this market has resulted in a diversified pipeline of companion diagnostic tests designed for management of different tumor forms.
Non-small cell lung cancer, breast cancer, and colorectal cancer are recognized as the prominent cancer types with major revenue share in the market. This is due to a substantial number of ongoing clinical trials and high penetration of CDx for these types.
The technology progress in oncology companion diagnostics market is projected to gradually evolve from the “one biomarker, one disease” paradigm to “multiple biomarkers, one disease” or “one biomarker, multiple diseases”. Also, multi-biomarker assays are anticipated to become a standard of care as a result of rapid ongoing developments to boost the efficiency of these assays. This, in turn, is expected to contribute in the future adoption of these assays.
Furthermore, understanding the pivotal role of companion diagnostics in malignancies treatment, several pharmaceutical companies have begun incorporating biomarker panels in their therapy development protocols. For example, Ignyta Inc. has incorporated proprietary algorithm-based biomarker panels and NGS technology in its STARTRK-2 trial for identification and characterization of molecular or genetic variation in patients with malignancies. The trial is designed to investigate entrectinib’s effect against molecular variations including TrkA, TrkB, TrkC, ROS1, and ALK in patients.
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