No. Novartis does not provide any METex14 CDx testing patient support programs. For information about Foundation Medicine billing and reimbursement services, including financial assistance options, customers may call Foundation Medicine at 1-888-988-3639 or visit https://www.foundationmedicine.com/patients#financial-support.
Uninsured patients or patients who are concerned with out-of-pocket costs may apply for financial assistance through Foundation Medicine’s financial assistance program. Patients may apply to the Foundation Medicine financial assistance program by calling 1-888-988-3639 or by visiting their patient website at https://www.foundationmedicine.com/patients#financial-support.
A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.
Foundation Medicine describes FoundationOne®CDx as a comprehensive genomic profiling (CGP) test. A CGP test uses next-generation sequencing (NGS) for the detection of substitutions, insertions and deletions, and copy number alterations as well as genome-wide biomarkers such as microsatellite instable (MSI) or tumor mutational burden (TMB) from tumor specimens. If a customer has further questions, they may visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
NGS means next-generation sequencing.
- Next-generation sequencing is defined as technology allowing one to determine the sequence of a DNA molecule, or DNA molecules, in a single test run.
METex14 is an abbreviation for “MET exon 14 skipping.”
FoundationOne®CDx is clinically validated as a CDx to identify METex14.
To learn more about FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
The Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD) for qualifying patients who receive NGS with FDA-approved tests including FoundationOne®CDx.
For questions about the FDA-approved FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
METex14 is an oncogenic driver and knowledge of METex14 status can inform up-front treatment planning.
METex14 is present in ~3% of patients with mNSCLC. Patients with METex14 face a poor prognosis and only patients with METex14 are eligible for biomarker-driven therapy with TABRECTA.
Patients with METex14 in mNSCLC face a poor prognosis.
TABRECTA™ (capmatinib) 150 mg, 200 mg tablets is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Knowledge of METex14 status can inform an up-front treatment plan. Test for METex14 when a patient presents with mNSCLC (stage IV). METex14 is generally stable throughout the course of the disease.
- It is imperative to use a test specifically designed to detect METex14 to identify patients who are eligible for treatment with TABRECTA™ (capmatinib) 150 mg, 200 mg tablets.
- There have been specific algorithmic improvements applied to the pipeline in order to improve FoundationOne®CDx assay ability to detect METex14 skipping automatically.
The performance of FoundationOne®CDx to detect mutations leading to METex14 was demonstrated in a retrospective analysis of specimens from 78 patients enrolled in the GEOMETRY mono-1 trial.
- GEOMETRY mono-1 was a multicenter, nonrandomized, open-label, multicohort study evaluating 97 adult patients with NSCLC with a mutation that leads to METex14 skipping. Patients received TABRECTA tablets 400 mg orally twice daily.
- GEOMETRY mono-1 used an RNA-based reverse transcription-polymerase chain reaction (RT-PCR) assay to screen patients for METex14.
- Out of 78 samples that were retested using FoundationOne®CDx, 73 were evaluable. FoundationOne®CDx demonstrated an estimated positive percentage agreement of 99% (72 of 73) with the RNA-based RT-PCR clinical trial assay, which confirmed METex14 skipping for TABRECTA.
Foundation Medicine generally expects to provide results in less than 2 weeks after the specimen is received. It is important to educate patients that the test results help inform up-front treatment plans.
For more information, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
For specimen shipment kits for FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
For specimen handling instructions for FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
Yes. Foundation Medicine's FoundationOne®CDx is an FDA-approved CGP test which uses next-generation sequencing for the detection of METex14.
For more information about the FoundationOne®CDx, visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.
If you have questions about specimen types when ordering the FoundationOne®CDx, please contact Foundation Medicine at 1-888-988-3639 or visit FoundationOneCDx.com.