Foundation Medicine, a leader in precision medicine transforming cancer care, announced that it has achieved a landmark milestone of 100 approved companion diagnostic indications across the United States and Japan. This milestone includes approvals for both FoundationOne CDx and FoundationOne Liquid CDx, with 57 approvals in the U.S. and 43 in Japan. The recent approval by Japan’s Ministry of Health, Labour and Welfare for FoundationOne CDx to support targeted therapy in NTRK fusion-positive solid tumors underscores the company’s role as the first and only organization to reach 100 companion diagnostic indications for next-generation sequencing.
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Companion diagnostics are specialized tests that enable healthcare providers to match patients to therapies with precision. These tests are recognized as the gold standard in personalized cancer care and undergo rigorous evaluation by independent regulatory agencies to ensure accuracy and reliability. They allow clinicians to identify patients most likely to benefit from specific therapies and provide actionable insights to guide individualized treatment decisions.
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Dan Malarek, Chief Executive Officer at Foundation Medicine, said that the company has been a pioneer in high-quality genomic testing, being the first to undergo parallel review by the U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services. This process led to FDA approval of FoundationOne CDx as a pan-tumor companion diagnostic and a landmark national Medicare coverage determination. He emphasized that reaching 100 approved companion diagnostic indications empowers healthcare providers to rely on comprehensive genomic profiling tests that are both clinically actionable and of the highest quality. Malarek added that Foundation Medicine remains committed to improving patient outcomes by matching individuals to the most effective therapies based on the unique genetic profile of their cancers.
Foundation Medicine leads globally in companion diagnostic approvals, holding more next-generation sequencing indications in the United States and Japan than any other company. Achieving 100 approved companion diagnostic indications strengthens the confidence of biopharmaceutical partners and accelerates innovation, enabling faster development of new therapies. The company has collaborated with drug developers to bring more than 35 medicines to patients and has delivered over 1.5 million comprehensive genomic profiling reports.
Foundation Medicine offers both tissue- and blood-based testing options to detect genomic alterations that inform treatment decisions. FoundationOne CDx uses tissue samples to analyze over 300 cancer-related genes, while FoundationOne Liquid CDx provides genomic insights from a blood sample, allowing clinicians to guide personalized care decisions efficiently. These testing platforms continue to advance precision medicine, helping patients and providers make informed, targeted treatment choices.
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