Foundation Medicine has been a pioneer in leveraging deep genomic insights to inform cancer treatment decisions. Our mission is to ensure every patient benefits from the latest science at the time of their treatment, and our belief in this mission, which remains steadfast as we enter our second decade, drives our scientists, bioinformaticians and engineers to develop next generation products that bring high quality and reliable genomic information into routine clinical care.
Now that the FDA has approved FoundationOne®Liquid CDx as the most comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications, not only do we have further validation of the genomic information that our tests provide to patients and their doctors, but we’re also delivering on our promise to bring breakthrough advancements that fundamentally change the way cancer is treated.
With this latest approval, we’re able to offer patients and oncologists two FDA-approved genomic testing options to guide treatment decisions using deep molecular insights from each individual tumor.
The Importance of Testing Options
Providing testing options is important because cancer is complex and often evolves quickly and every patient, every diagnosis, every treatment plan is unique. As such, an oncologist would never treat a patient without a pathological diagnosis—they would never tell patients they have cancer or discuss disease stage without a blood or tissue-based biopsy. Biopsies are the source of information on which cancer treatment is based. It’s this information that helps oncologists, along with the multidisciplinary teams who partner with them, make the most informed decisions about a patient's next steps.
Tissue biopsies have been incredibly important for diagnosis, prognosis and treatment decisions for quite some time, but in recent years, liquid biopsy has emerged as another reliable way to garner deep information about what’s driving a patient’s cancer, while addressing a critical need for less invasive options. Both liquid and tissue biopsy have an important place in cancer care and play significant roles in expanding patient access to precision medicine.
Two FDA-Approved Tests; One Source of Insight
Foundation Medicine’s recently approved liquid biopsy test, FoundationOne®Liquid CDx, analyzes more than 300 cancer related genes for alterations and includes multiple companion diagnostic claims to identify patients who may benefit from treatment with specific FDA-approved targeted therapies. In the professional services section of the report, it reports genomic signatures microsatellite instability-high (MSI-H) and blood tumor mutational burden (bTMB), which are important signatures to add to standard PD-L1 testing because they may help identify more patients who could benefit from immunotherapy.
Creating two comprehensive genomic profiling (CGP) tests that complement each other and provide oncologists with the same high-quality insights regardless of the specimen type is no easy task. Measuring circulating tumour DNA (ctDNA) in the blood with reproducible accuracy is extremely challenging because tumor DNA is a small fraction of the DNA content in plasma; this means we needed to build a highly-sensitive liquid biopsy platform that can distinguish cancer-related mutations.
As such, our teams worked diligently to ensure that our tissue- and plasma-based tests meet the same high-quality standards, not only in content, but also in the way in which we bioinformatically define variants and mutations in both tissue and liquid samples.
This means healthcare professionals can consider complementary results from both tests regardless of timing of the tests performed and the specimen type used, which gives them the ability to understand disease evolution over time with data based on the same algorithms and gene list.
Reflexing, not Replacing
While there are no absolutes for determining whether a tissue or liquid biopsy is the best option for an individual patient, there are some factors to consider.
Liquid biopsy-based next generation sequencing (NGS) tests are minimally invasive, highly sensitive and specimen samples are generally quick to obtain. They help oncologists obtain rapid information about a patient’s tumor, allowing providers to begin molecularly driven treatment quickly - often at a time when every day counts. It is clear that a wide range of cancer types shed ctDNA into the blood, including those that commonly metastasize to the bone or liver such as lung, prostate, GI, and breast cancers.
Further, not only is liquid biopsy a valuable tool when ctDNA can be derived from plasma, but many advanced cancer patients are too unwell to cope with a tissue biopsy procedure or their tumor is inaccessible through surgery. In these cases, liquid biopsies can be a reliable alternative option to obtain deep genomic insights into what’s driving a patient’s cancer.
But as valuable as liquid biopsy is, we’re still learning about the science and believe providing options is critical to treating each individual patient. For example, not all tumors shed DNA into the bloodstream. Also, when disease burden is low, it is often difficult to detect shed tumor DNA in plasma - if there is no tumor DNA in the specimen, then negative testing results aren’t useful. For this reason, FoundationOne Liquid CDx is designed to specify when no tumor DNA was detected and indicate that a reflex to a tissue analysis is necessary. Thus, the two tests, tissue and liquid, can be complementary.
More Options for More Patients
With the increasing complexity in cancer care, providers need consistent and reliable information about what’s driving their patient’s disease, and scientists need CGP platforms with the highest quality clinical and analytical validity to advance research and ultimately deliver the next therapeutic developments to clinical care.
Our mission to continue delivering breakthroughs for patients doesn’t stop here. We hope that precision cancer care becomes routine in the treatment decision algorithm and not as a last resort considered only when patients are out of options. We remain committed to ensuring every patient has access to deep genomic insights about their cancer and now, with two FDA-approved CGP platforms, we’re one step closer to delivering on that promise.