A New Decade of Possibility for Precision Oncology

Foundation Medicine has a clear and ambitious goal – to transform oncology and redefine the way each person with cancer is treated. We believe all patients deserve the highest quality, actionable genomic information to inform and optimize their individual treatment plan. And there are two important elements to this that define our approach to precision oncology and help guide our path forward.

The first is access, and by this, I mean delivering the tools necessary to open up the benefits of precision oncology to as many patients as possible, as rapidly as possible.

The second equally important element is quality. In such a rapidly evolving and complex treatment landscape, it’s vital that physicians are confident in the insights that they receive from genomic analysis to inform the decisions about treatment approaches they choose for their patients.

Ensuring advanced cancer patients have access to high quality genomic information about their cancer is what drives our path forward; a path that delivers progress and options for patients now while creating the benchmarks and setting the standards for precision oncology in the future.

For me, our latest step forward is a true demonstration of our approach in action; yesterday’s  announcement of the U.S. Food and Drug Administration (FDA) approval of FoundationOne®Liquid CDx, our comprehensive pan-tumor liquid biopsy test along with multiple companion diagnostic claims. From a simple blood draw, FoundationOne®Liquid CDx analyzes over 300 genes for alterations known to drive cancer growth and within the professional services section of our report, includes information on genomic signatures, including high microsatellite instability (MSI) status and blood tumor mutational burden (bTMB), as well as all NTRK fusions, arming physicians and patients with deep molecular insights to guide informed decisions on the potential use of targeted therapies, clinical trials or immunotherapy as part of their individual treatment plan.

Not only is FoundationOne Liquid CDx the most comprehensive FDA-approved liquid biopsy test of its kind to help physicians make informed decisions about personalized treatment, regardless of cancer type, but it has also been granted coverage for eligible Medicare and Medicare Advantage beneficiaries by the Centers for Medicare and Medicaid Services (CMS) and will be commercially available tomorrow. This is an important step forward in expanding access to precision medicine for eligible patients with advanced cancer.

An important option for advanced cancer patients

Reaching this point, where we can offer patients the broadest FDA-approved CGP liquid biopsy test with multiple companion diagnostic claims is the result of several years of research and collaboration to evolve the science and help establish the clinical utility of liquid biopsy in patient care. And, while tissue samples remain incredibly important for understanding the genomic drivers of a patient’s cancer, every patient is different and unfortunately, for many, a tissue biopsy is not an option.

If you look at non-small cell lung (NSCLC) cancer for example, approximately 30 percent of patients do not have enough tissue available for testing. And, regardless of tissue availability, patients with advanced cancer are sometimes too unwell to cope with a tissue biopsy procedure, an additional barrier to accessing the benefits of precision oncology. There is a critical need for minimally invasive methods to connect these patients to genomic insights that could match them to targeted treatment, and in cases where there is not enough circulating tumor DNA in a patient’s blood sample, our portfolio approach allows physicians to reflex, or switch, to a FoundationOne CDx tissue test.

Delivering actionable insights

Approximately 50 percent of new cancer drugs in development are projected to have a companion biomarker.¹ And, as these new biomarker driven therapies become available, we’re seeing an increased need for coinciding companion diagnostic tests to identify patients eligible for these treatments.

Companion diagnostics tests are incredibly important for matching patients with FDA-approved targeted therapies and are essential for the safe and effective use of these treatments. This is why we’re proud that FoundationOne Liquid CDx is also an FDA-approved companion diagnostic for four targeted cancer therapies, which meet critical needs in lung and prostate cancer. One of these therapies was the first PARP inhibitor approved for patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC), and now, with an FDA approved liquid companion diagnostic, healthcare professionals can identify patients eligible for this treatment through a simple blood draw.

And, as we continue to work with our biopharma partners, FoundationOne Liquid CDx will serve as an important, FDA-approved, pan tumor platform for developing companion diagnostics to help advance their clinical programs, understand mechanisms of resistance and accelerate the development of new targeted therapies.

A framework for the future of oncology

Foundation Medicine was proud to pave the way for regulatory approvals of this kind when we took our flagship test, FoundationOne CDx, through the approval process with the FDA in 2017. The industry standards for genomic testing that we created through this process ensure patients and their physicians are receiving the highest quality genomic information available. That’s why today’s approval is such an important milestone. We can now offer oncologists multiple FDA-approved, high-quality comprehensive genomic profiling options that allow them to bring biomarker-driven care to even more patients than before. And, our biopharma partners, another FDA-approved platform – beyond our tissue-based assay – for companion diagnostic development to advance their therapeutic programs.

At Foundation Medicine, we believe that continued collaboration and innovation is vital to ensuring more patients are able to realize the benefits of precision medicine. And, as we celebrate our ten-year anniversary as a company, we remain committed to working together to bring these types of breakthroughs to patients.  

^{[1] Developments in Cancer Treatments, Market Dynamics, Patient Access and Value - Global Oncology Trend Report 2015. IMS Institute for Healthcare Informatics.}