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Introducing FoundationOne Liquid

With a single tissue biopsy and comprehensive genomic profiling (CGP), people diagnosed with cancer have access to more information about their disease than ever before. These insights are rapidly advancing precision medicine and giving patients the chance to find the treatment most likely to benefit their specific disease.

But what about when tissue is not accessible? What if their disease has already progressed or their cancer has acquired resistance to a previous therapy, and rapid results are needed to adjust treatment course? While tissue biopsy testing is optimal for CGP, we recognize that it may not be an option for some patients.

At Foundation Medicine, we believe that every patient should have access to quality genomic profile testing regardless of their tissue status or stage of treatment. That is why we are proud to announce the broad commercial availability of FoundationOne®Liquid, our most advanced liquid biopsy test to help inform cancer treatment decisions.

Using a simple blood draw, FoundationOne Liquid can help guide physicians to the most appropriate targeted therapy, immunotherapy or clinical trial for their patients with an expanded gene list of 70 genes known to drive cancer growth. Importantly, FoundationOne Liquid also reports microsatellite instability high (MSI-H) status, which is becoming an increasingly important biomarker to predict response to cancer immunotherapies. In fact, the FDA recently approved an anti-PD-1 immunotherapy for any solid tumor that is MSI-high, regardless of its location in the body, underscoring the importance of making genomic profiling available to as many patients as possible.

FoundationOne Liquid also now includes a number of genes, including homologous recombination deficiency (HRD) genes, that can guide clinical trial enrollment and inform the use of multiple targeted therapies, including a class of medicine known as PARP inhibitors that can be used across a number of disease types.

FoundationOne Liquid Benefits

This launch comes at a critical time for a growing number of cancer patients who need access to the latest liquid biopsy technologies. Right now, up to 30 percent of patients with non-small cell lung cancer (NSCLC) do not have adequate tissue available at diagnosis for standard biomarker testing.1 This is why the NCCN guidelines now state that in lung cancer, liquid biopsy is an acceptable first option for molecular profiling at disease progression.2

FoundationOne Liquid can have a meaningful impact for these patients, as it expands upon the previous version of our liquid biopsy test, FoundationACT®, which has been analytically validated across the four main classes of genomic alterations3 and it meets our highest standards for sensitivity.

We know there is more that we can still do, and we are constantly innovating to meet the new and growing needs of the cancer community. In fact, a forthcoming version of our liquid biopsy test currently in development recently received Breakthrough Device designation from the FDA and will include the genomic biomarker blood tumor mutational burden (bTMB), which we recently showed could serve as a minimally invasive predictor of response to immunotherapy in NSCLC patients.

The full potential of precision oncology will only be met when as many patients as possible have the opportunity to benefit. We believe FoundationOne Liquid, and our long-standing commitment to advancing liquid biopsy technologies, can play an important role in making that happen.

Notes

1 Gandara et al. “Blood-based tumor mutational burden (bTMB) as a novel predictor of clinical benefit in NSCLC patients treated with atezolizumab.” Nature Medicine. 6 August 2018. Available at: https://www.nature.com/articles/s41591-018-0134-3

2 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.2.2018.

3 Clark et al. Analytical validation of a hybrid capture-based next-generation sequencing clinical assay for genomic profiling of cell-free circulating tumor DNA. The Journal of Molecular Diagnostics. 2018. doi: https://doi.org/10.1016/j.jmoldx.2018.05.004

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