Targeted therapies target specific underlying genomic alterations that are contributing to tumour growth. By attacking the cancer and sparing the surrounding tissue, targeted therapies could be more effective and have fewer or less pronounced side effects than traditional chemotherapies. Since there are hundreds of genes that can have alterations in cancer, and many possible alterations in each gene, the number and combination of genomic alterations make each person’s cancer unique. Immunotherapies harness the body’s own immune system to attack cancer cells. Targeted therapies and immunotherapies may be available as Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Medicines and Healthcare products Regulatory Agency (MHRA)–approved therapies or they may be available as part of a clinical trial.
We will send the results via your Foundation Online account and/or by secure email.
You are solely responsible for any and all action(s) undertaken as a result of the information provided in the FoundationOne® CDx , FoundationOne® Liquid CDx or FoundationOne® HEME report and Roche does not seek to recommend any particular medication(s) referred therein. It is your responsibility to evaluate and interpret the information provided in the report, along with all other available clinical information regarding your patient, in order to determine the best treatment decision(s) in your own independent medical judgment, and as far as possible in collaboration with other healthcare professionals involved in the care of your patient.
FoundationOne® CDx, FoundationOne® Liquid CDx and FoundationOne® HEME may identify an "actionable" alteration(s) helping:
- Identify an EMA-approved therapy for the patient's tumour type and shown to target one or more of the genomic alterations found by the service,
- Identify an EMA-approved therapy in another tumour type and shown to target one or more of the genomic alterations found by the service, or
- Identify clinical trials of a licensed or experimental treatment which may work by targeting an alteration found by the service or a relevant pathway
The results will provide information on any acquired genomic alterations found in a patient's tumour but are not intended to provide information on inherited genetic alterations. It is important to remember that only 5–10 percent of cancers are caused by hereditary alterations.1 However, since these alterations can be inherited by multiple family members and passed down from generation to generation, information about inherited alterations affects entire families, raising personal and ethical considerations that factor into the decision to receive that information. Foundation Medicine is not a service for inherited alterations.
1. https://www.cancer.gov/about-cancer/causes-prevention/genetics (last accessed July 2023)
There is a possibility that in some cases, FoundationOne® CDx, FoundationOne® Liquid CDx and FoundationOne® HEME results don't identify an actionable genomic alteration, meaning there are no approved treatments or therapies in clinical trials that have been shown to be effective against the alterations found in a patient’s tumour. Additionally, there may be obstacles to obtaining therapy in cases where the service finds actionable alterations. For example, if the therapy has been approved in a different tumour type, there may be no reimbursement for the cost of that treatment for an unapproved tumour type. It is also possible that a patient may not be eligible for, or able to enrol in an ongoing clinical trial of a therapy targeted against an alteration found by the service.
It is important to understand that while the service often provides valuable information to help healthcare professionals make the best possible decisions about treatment, there is no guarantee that the treatment identified will work for the patient. While significant progress has been made in treatments targeting the underlying genomic alterations that cause cancer, cancer is a complex disease driven by multiple factors, no therapy is 100 percent effective and responses to therapies vary.
FoundationOne® CDx requires 25mm2 surface area or 1 mm3 volume of FFPE tissue, of which a minimum of 20% should be of malignant origin, however 35% is optimal, on 11 unstained slides or from a block reviewed and approved by a pathologist as the most representative block for the patient diagnosis. All solid tumour types are acceptable. Foundation Medicine is able to process any clinical sample that meets these guidelines. Should your sample be insufficient or unsatisfactory you will be notified as soon as possible following receipt.
When choosing a biopsy for submission, the specimen must meet specimen guidelines relevant to the test ordered. A recent sample of a patient’s tumour is preferred as genomic alterations are known to change over time and with treatment. The service can be run on a tissue sample from an earlier biopsy of either the primary tumour or cancer cells that have spread to other parts of the body. If there is not enough tissue remaining from an earlier biopsy to run the service an additional biopsy may need to be collected. It may be required to take a new biopsy to get a more recent sample. If choosing between multiple specimens, the most recent specimen with the highest nucleated cellularity and tumour content should be chosen. If the tumour has metastasised and meets our specimen requirements, it is best to submit a specimen from the metastatic site.
The analytic performance of FoundationOne® Liquid CDx is comparable to other next-generation sequencing-based broad molecular profiling assays for liquid biopsies.1
FoundationOne® Liquid CDx uses circulating tumour (ct)DNA and provides an alternative biopsy service for patients that are not suitable candidates for the tissue-based FoundationOne® CDx service. Cell-free DNA (cfDNA) is released from tumour tissue and circulates in the blood, this can be examined following cfDNA extraction using a blood draw. ctDNA is highly fragmented, occurs in very low amount and varies between both tumour types and individual patients. This method may be an appropriate technique when:
- A quick single blood draw is preferable for the patient
- Insufficient or inadequate tissue from a recent biopsy can be obtained
- The tumour is “difficult to biopsy”
- Biopsy poses an unacceptable risk to the patient or is contraindicated
- Progression or recurrence are suspected and repeat biopsy is infeasible
The FoundationOne® Liquid CDx and FoundationOne® CDx output is an EU-based report, which may include therapies approved through a centralised EU procedure or a national procedure in an EU Member State.
1. Woodhouse R, et al. PLoS One. 2020;15:e0237802.
FoundationOne® Liquid CDx requires two tubes of peripheral whole blood (8.5 mL per tube), filled to the marked level. Each tube should be mixed by gentle inversion 8 to 10 times – inaccurate or delayed mixing may result in inaccurate test results (one inversion is 180 degrees). All solid tumour types are acceptable. Foundation Medicine is able to process any clinical sample that meets these guidelines. Should your sample be insufficient or unsatisfactory you will be notified as soon as possible following receipt.
CGP: comprehensive genomic profiling; EMA: European Medicines Agency; FDA: Food and Drug Administration; MSI: microsatellite instability; TMB: tumour mutational burden.
M-GB-00009177 July 2023