Why do we need CGP?
Precision medicine is transforming cancer therapy, from an organ-based approach to personalised intervention for individual patients.7 Large-scale genomic profiling of tumours with comprehensive genomic profiling (CGP), guide the selection of effective targeted treatment to the unique genomic profile of a patient’s tumour.2–4,13–15
How is the approach of cancer therapy changing?
Cancer therapy is moving from seeing cancer as a disease of the organ to a disease of the genome. Genomic insights can enable patients to receive more personalised treatment.16
Why are cancer mutations important?
Even if a patient has the same type of cancer as someone else, their individual patient profile may differ, and they may need a different treatment.16
Can targeted therapies improve outcomes?
Treating patients based on their individual patient profile leads to better patient outcomes across cancer types: 2,18–20
Biomarker-based approaches are associated with improved efficacy
How many targetable mutations are there?
Medical knowledge about clinically relevant genomic alterations is continually increasing:21
Identifying gene variants in individual patients may result in existing anticancer drugs having value beyond their organ-based approved indications, expanding the range of patients who may benefit from their use.3
How can we identify a patient’s cancer mutations?
There are several different types of genomic testing, which include single biomarker testing, hotspot testing and CGP. Single biomarker testing and multigene hotspot testing only look for predefined mutations within limited regions in cancer cells’ DNA.25 CGP provides a more complete picture of a patient’s cancer by searching for multiple mutations across a broad region of the cancer cells’ DNA with a single test, helping to increase the chance of finding important mutations right away.8,26,27
Using a high-quality test, which is analytically and clinically validated, is important for avoiding harm to patients and ensuring appropriate treatment selection.28,29
CGP identifies genomic alterations that may be missed by other tests25
CGP is required to identify the right therapeutic options for the right patient because:
- Every patient’s cancer could have a unique set of mutations16
- Knowing a patient’s cancer mutations can help personalise their treatment7,30
- CGP can identify cancer mutations that may be missed by single biomarker and hotspot testing*25
*Due to limits in the number of genes tested, omission of certain coding regions and low depth of coverage.
How can CGP benefit payers?
CGP is expected to contribute to better patient outcomes, while having a low budget impact with the potential to generate savings compared to traditional cancer molecular diagnostics.2,5–7,31
As more targetable mutations are identified, and treatment choice grows, there is an increasing demand for institutions and healthcare systems to remain at the forefront of oncology. CGP provides a wide range of genomic insights to guide precision medicine decisions, helping to improve the consistency and structure of care and streamline patient management efficiency.1–7
What are the benefits of CGP?
CGP increases the chances of finding important mutations right away and may also increase the chance of finding a more precise treatment.8,25
CGP is expected to contribute to better patient outcomes, have a low budget impact, helping clinicians quickly find the right treatment options for their patients and avoiding costs related to unnecessary or unsuitable treatment.2,5–7,31
Cost dynamics as result of CGP use2,5–7,31
The complexity and vast amounts of information generated through genomic profiling techniques, like CGP, make expert review through ‘molecular tumour boards’ (MTB) important to translate genomic profiles into optimal care for patients. MTBs are composed of oncologists, pathologists, bioinformatics experts, molecular biologists, geneticists, etc., which take into consideration a number of evidential resources (e.g. databases, clinical trial results, basic knowledge about mutations and pathways) that need to be associated with the clinical trajectory of individual patients. MTBs have shown to be able to deliver the following values beyond others:32–37
- Improvement of patients’ outcomes by providing multidisciplinary tailored-based treatment advice
- Cost-saving by predictive diagnostics preventing ineffective therapy
How does the cost of CGP compare to common diagnostic tests?
Compared to CGP, common diagnostic techniques (such as PCR/IHC/FISH, and multigene hotspot NGS tests) risk missing genomic alterations,* which may be critical to a patient’s treatment plan.5,6,25 The reduced need for repeat testing vs. one upfront test means that CGP can result in cost savings compared to sequential single gene and hotspot testing.38 Any additional costs related to CGP and targeted treatment may be offset by a reduction in costs related to in-patients, a reduced number of biopsies, the need for repeat testing and also end-of-life patient situations.39
*Due to limits in the number of genes tested, omission of certain coding regions and low depth of coverage.
Cost savings associated with CGP compared to other testing strategies38
How does the cost of CGP-driven targeted therapy compare to standard of care?
Compared to standard of care, targeted therapy guided by genomic profiling may improve overall survival for refractory cancer while lowering average per-week healthcare costs, resource utilisation, and end-of-life costs. The additional cost of CGP and targeted treatment, in comparison to standard of care, may be offset by reductions in hospitalisations and emergency visits, including end-of-life care.39
Cost per patient in the last 3 months of life39
Be at the forefront of healthcare by recognising the potential of CGP:
- CGP provides a wide range of genomic insights to guide precision medicine decisions8
- CGP can result in cost savings compared to common diagnostic tests38
- CGP-driven targeted therapy is expected to have a low budget impact and contribute to better patient outcomes1,3,31
Contact us to find out how CGP can benefit your
institution or healthcare system
Why use Foundation Medicine’s CGP services?
Roche Foundation Medicine’s extensively validated portfolio of CGP services helps institutions and healthcare systems offer the best standard of care for cancer diagnostics.8–12,43
FoundationOne®CDx for solid tumours, the first CGP diagnostic test to be reviewed and approved by the FDA, has been validated with 6,300† samples, allowing confidence in the sensitivity, accuracy and clinical outcome of our services.40,42
This is:
• over 120 × more than the typical number of patient samples used for laboratory test validations‡
• 9 × more samples as compared with FoundationOne40,41
FoundationOne Liquid CDx, our highly accurate and extensively validated, next-generation liquid biopsy genomic profiling service for all patients with solid tumours, has been validated with >7,500 samples covering >30,000 unique variants across >300 genes and 37 cancer indications.10,43
This is:
• 150 × more samples than the typical number of patient samples used for laboratory test
validations‡41 and a similar number of samples as for validation of FoundationOne®CDx40
• 12 × more variants than the number of variants used for validation of our earlier liquid-based test FoundationOne Liquid44
Like FoundationOne CDx, FoundationOne Liquid CDx is based on our analytically and clinically validated, FDA approved, comprehensive platform and bioinformatics
workflow.§9,10,42,45,46
†2,100 clinical and 4,200 analytical samples.
‡According to NYS guidance.
§Clinical validation based on evidence gathered using an earlier version of Foundation Medicine’s current liquid biopsy service, FoundationOne Liquid CDx. For concordance results between these two tests, please see our full intended use at www.foundationmedicine.com/F1LCDx.
Watch the video to learn more about the Foundation Medicine approach:
What services does Roche Foundation Medicine offer?
Roche Foundation Medicine offers a high-quality portfolio of CGP services which can be used with blood and solid tissue samples for patients in diverse clinical situations.9-11
What do the results look like?
With each Roche Foundation Medicine service, the clinician will receive a clear and concise report.47 Approved targeted therapies and immunotherapies for the patient’s gene alterations and genomic signatures are ranked alphabetically within NCCN therapy categories (for additional information on the NCCN categories please refer to the NCCN Compendium® at www.nccn.org). Roche Foundation Medicine can also provide Mutational Tumour Board (MTB) support which can help your teams to better understand genomic profiling data and identify the right treatment choice for each patient.
What additional support can Roche Foundation Medicine provide?
Roche Foundation Medicine provides a portfolio of services which go beyond the report, meaning that we can work alongside your existing on-site services to support decision-making, build skills and help manage service demand.
Now is the time to partner with Roche Foundation Medicine so that we can build the future of precision medicine together:
- We offer a portfolio of CGP services for patients in diverse clinical situations9-11
- Our FoundationOne CDx and FoundationOne Liquid CDx services have been reviewed and approved by the FDA, 42,46 and have been extensively analytically and clinically validated (6,300 samples and >7,500 samples, respectively)§40,45
- Our CGP services are widely used in clinical research, where accuracy and consistency are of utmost importance 48,49
- We provide a detailed report and a range of support services to aid decision-making47
§Clinical validation based on evidence gathered using an earlier version of Foundation Medicine’s current liquid biopsy service, FoundationOne Liquid CDx. For concordance results between these two tests, please see our full intended use at www.foundationmedicine.com/F1LCDx.
¥For additional information on the NCCN categories please refer to the NCCN Compendium® (www.nccn.org).