Healthcare Providers
What is FoundationOne?
FoundationOne™ is the first pan-cancer, fully informative genomic profile designed to help you identify potential treatment options for your patients based on a comprehensive assessment of the molecular changes driving the growth of their tumor. FoundationOne is optimized to fit current medical practice. It uses next-generation sequencing to interrogate hundreds of cancer related genes from routine tumor samples. Test results are provided in a simple report that aligns detected mutations with potentially relevant treatment options and clinical trials. Click here to download a technical guide, including the list of genes included in the comprehensive assay.
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FoundationOne is the first pan-cancer, fully informative genomic profile to help expand patients' treatment options.
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For all solid tumors, FoundationOne detects all classes of gene alterations that may drive cancer.
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On average, FoundationOne identifies 2 to 3 genomic alterations per patient that may inform treatment decisions with targeted therapies or clinical trials.
FoundationOne may help you identify what could otherwise be unappreciated treatment options and clinical trials, both within and beyond standard of care, for your patients' malignant solid tumors.
Today, we know more about the complexity of cancer than ever before. Whereas there used to be a handful of “biomarkers” to guide therapy in a few cancer types, there is now a growing arsenal of molecular targets and therapies against those targets across all cancers. Cancer complexity defies single marker analysis. With FoundationOne you can have a comprehensive genomic profile for each individual patient.
How FoundationOne works
FoundationOne enables you to easily integrate comprehensive molecular information into patient care.
You check one box on the FoundationOne requisition, and leave the test logistics to us. Foundation Medicine retrieves the patient sample from the pathology laboratory, sequences and analyzes the tumor and sends an interpretive report for each patient. The report highlights clinically actionable molecular changes that may guide therapy and provides the supportive scientific and medical literature you need to evaluate potential treatment options. FoundationOne complements traditional cancer treatment decision making tools and helps you easily incorporate the latest scientific and medical data into your treatment decisions.
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Check one box – we do the rest. Foundation Medicine will handle specimen acquisition and patient billing so you can focus on patient care.
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No need to worry about which tests to order, the relevant genomic information you need to evaluate targeted therapy options for your patients is encompassed in one test.
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FoundationOne can be performed on very small amounts of formalin-fixed, paraffin embedded tissue, providing comprehensive molecular information and preserving precious tumor tissue.
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In-house experts are available for consultation on test results and results are available within a clinically relevant time frame so you can act quickly.
How FoundationOne was developed
We have known for decades that cancer is a disease of the DNA, and since that basic premise has been understood, researchers, physicians and patients have dreamed about personalized cancer medicine but have lacked the necessary diagnostic tools. In the past several years, since the decoding of the first human genome, diagnostic sequencing technology has finally advanced to the point where targeted, deep, clinical-grade sequencing of cancer-related genes is possible.
World-renowned leaders in cancer genomics from Dana-Farber Cancer Institute, the Broad Institute, Harvard University and MIT founded Foundation Medicine to realize the vision of personalized medicine, bringing the latest technology and information to cancer patients, particularly in the community setting where most are treated.
This goal has been made a reality thanks to the work of Foundation Medicine’s experts in the field of cancer genomics and medical oncology. FoundationOne, a fully informative genomic profile, is the result of years of dedicated work and combines four fields of study:
- Information science and computational biology
- Genome technology
- Cancer biology, and
- Clinical oncology
Foundation Medicine is the first company with the ability to implement advances in these fields in everyday care, giving oncologists the molecular blueprint of each patient's cancer to help inform a more targeted treatment strategy.
How to read the FoundationOne report
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The first page of the report shows the patient and ordering physician information…
The genomic alterations identified
in the hundreds of genes assayed…
The targeted therapies that may
be relevant based on those genomic
alterations both in the patients tumor
type and in other tumor types…
and whether there are relevant
clinical trials. -
The second page of the report contains a more detailed interpretive statement that references the frequency of the genomic alteration, its biological implication and what it may mean for the patient.
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The Therapies section of the report provides more details on approved therapies to which the patient's cancer may be sensitive or resistant based on its genomic profile.
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The Clinical Trials section of the report provides some detail on currently available clinical trials for which the patient may be eligible based on the genomic profile of the patient’s cancer. This section also provides guidance to the physician to help identify other trials in publicly available databases for which the patient may be eligible.
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The Appendix contains reference information for all of the studies that were used in curating the report, as well as the complete list of genes assayed in the test.
FAQs
What is FoundationOne?
FoundationOne is the first pan-cancer, fully informative genomic profile designed to help you identify potential treatment options for a patient based on a comprehensive assessment of the molecular changes driving the growth of their tumor. This profile reveals the unique genomic profile of a patient's solid tumor and matches genomic alterations with actionable information about targeted therapies and trials. Click here to download a technical guide, including the list of genes included in the comprehensive assay.
How do I order FoundationOne?
FoundationOne utilizes routine formalin-fixed, paraffin-embedded clinical samples, which may be available from a previous biopsy or surgery. We have made the ordering process as simple as possible, so all your office needs to do is complete a requisition form, while we take care of pathology coordination, insurance and reporting. Click here for more ordering information.
What specimen do I need to send?
FoundationOne requires 40 μm of FFPE tissue, of which ~20% or more is
of malignant origin, on 8 to 10 unstained slides or from a block
reviewed and approved by a pathologist as the most representative block
for the patient diagnosis. All solid tumor types are acceptable.
Click here to download detailed specimen
requirements.
Foundation Medicine is able to process any clinical sample that meets these guidelines, should your sample be insufficient we will notify you within approximately two days of receipt.
Is the test covered by insurance?
Foundation Medicine bills the patient’s insurance company for FoundationOne, as the provider of service. Typically, it takes 60 to 90 days for the insurance company to respond to Foundation Medicine’s claims. During this time the patient may receive an Explanation of Benefits, this is not a bill and will explain the coverage initially offered by the insurance company for FoundationOne.
If the insurance company denies coverage, Foundation Medicine works on
behalf of the patient to attempt to obtain coverage and will assist in
pursuing appeals on your behalf to minimize the financial burden when
appropriate. We may also contact your office for assistance in the
appeals process.
Click here for a more detailed explanation of billing financial services.
How long does it take to get results?
Your office will receive a report in approximately 21 days. Click here for more information about understanding the results.
Who is eligible for FoundationOne?
FoundationOne is available for any patient with a malignant solid tumor. It may reveal additional relevant treatment options to consider for patients based on the molecular profile of their tumor or may help provide additional information for patients who are searching for clinical trial options.
How might FoundationOne be useful in my practice?
FoundationOne may reveal important molecular characteristics about a patient’s tumor and can provide supporting data to suggest targeted therapies or trials, many of which may not have been considered but are logical choices based on the genomic profile of a patient’s tumor. It removes the guesswork of deciding which individual tests to order.
FoundationOne is designed to report the genomic alterations required to guide informed treatment recommendations through a single test with extremely high, clinical-grade sensitivity and specificity for alterations within hundreds of relevant cancer genes.
Does FoundationOne predict response to chemotherapy or the likelihood of recurrence?
No, FoundationOne was not designed to predict response to chemotherapy or recurrence. FoundationOne helps match the genomic alterations present in a tumor with specific targeted therapies or clinical trials.
Who can I contact if I have additional questions?
FoundationOne Customer Services Team: (888) 988-3639
- Hours of operation: Monday through Friday, 8:00 am EST – 6:00 pm EST
- Online inquiry
Contact
At Foundation Medicine we are committed to providing our clients – both physician and patient – with the very best service. If, at any point, you have questions about FoundationOne, our capabilities or our procedures, Foundation Medicine’s dedicated Client Services team is on-hand to assist you at every step of the process.
FoundationOne Customer Services Team: (888) 988-3639
- Hours of operation: Monday through Friday, 8:00 am EST – 6:00 pm EST
- Online inquiry