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 or FoundationOne® Liquid 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 and FoundationOne® Liquid may identify an "actionable" mutation(s) helping:
1. 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,*
2. 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*
3. 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 FoundationOne® Liquid report may also include therapies approved by the FDA.
The results will provide information on any acquired genomic alterations1 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. 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. FoundationOne® CDx is not a service for inherited alterations.
1. https://www.cancer.gov/about-cancer/causes-prevention/genetics (last accessed November 2019)
There is a possibility that in some cases, FoundationOne® CDx or FoundationOne® Liquid 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.
- Updated gene list: FoundationOne® CDx has an updated gene list to capture the most clinically relevant genomic alterations. FoundationOne® CDx interrogates 324 known cancer relevant genes vs 315 known cancer relevant genes (FoundationOne®)
- Simplified report: FoundationOne® CDx has a simplified report format. Key clinical information is captured on the first page of the report. This will include any EMA-approved therapies for the identified tumour type and EMA- approved therapies in another tumour type alongside potential clinical trials
- Assessment of the four main classes of genomic alterations
- Assessment of Tumour Mutational Burden (TMB) and Microsatellite Instability (MSI)
- Tissue requirements
- Turnaround time (11–14 days – upon receipt of a viable sample in the Foundation Medicine Laboratories)
FoundationOne® CDx requires 40 \0x03BCm of FFPE tissue, of which a minimum of 20% should be of malignant origin, however 30% is optimal, on 10 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.
FoundationOne® Liquid 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. ctDNA is released from tumour tissue and circulates in the blood, this can be examined following ctDNA 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:
- 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 output is a US-based report, which may include therapies approved by the FDA, but not through the EMA at the time of testing – this is in contrast to the FoundationOne® CDx report, which may include therapies approved through a centralised EU procedure or a national procedure in an EU Member State.
FoundationACT® is a prior version of FoundationOne® Liquid, which has been analytically validated.
FoundationOne® Liquid has an updated gene list to capture the most clinically relevant genomic alterations. FoundationOne® Liquid interrogates 70 known cancer-relevant genes vs 62 known cancer-relevant genes (FoundationACT®).
CGP: comprehensive genomic profiling; EMA: European Medicines Agency; FDA: Food and Drug Administration; MSI: microsatellite instability; TMB: tumour mutational burden.
RXUKRFMI00120a November 2019