What is comprehensive genomic profiling?
Comprehensive genomic profiling (CGP) is a method of testing tumors that uses next-generation sequencing (NGS) to detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. CGP can identify possible underlying oncogenic drivers that may predict response, or lack thereof, to certain therapies. This testing can be performed on multiple specimen types including FFPE tissue, peripheral whole blood, bone marrow aspirate or extracted nucleic acid. CGP can help predict patient benefit across multiple targeted therapies in multiple cancer indications.
How is comprehensive genomic profiling different from single-gene or “hot spot” testing?
Single biomarker testing identifies alterations that are confined to a single gene, potentially missing clinically relevant mutations in additional genes. Gene hotspot testing may test multiple genes at a time but is confined to commonly altered regions within those genes, resulting in potentially missing other clinically relevant classes of alterations. Comprehensive genomic profiling detects the four main classes of genomic alterations across a broader panel of genes, oftentimes hundreds.
Which genes are tested?
Foundation Medicine tests look at more than 300 cancer-related genes:
FoundationOne CDx (324 DNA genes interrogated from a tissue sample)
FoundationOne Liquid CDx (324 DNA genes* interrogated from a simple blood draw)
FoundationOne Heme (406 DNA and 265 RNA genes interrogated from a variety of sample options)
*FoundationOne Liquid CDx is FDA-approved to report substitutions and inDels in 311 genes, including rearrangements and copy number losses only in BRCA1/2. Comprehensive results across all 324 genes, including bTMB, MSI-H status, and tumor fraction are reported in the professional services section of the report.
How do I order a Foundation Medicine test?
Online Ordering: For faster order processing, order online by signing up for a Foundation Medicine account.
Email Ordering: To order by email, download and complete a test requisition form, along with attachments (pathology report, insurance information, and Advance Beneficiary Notice if required), and email to firstname.lastname@example.org.
You can also place an order via fax by sending a completed test requisition form along with attachments to 617-418-2290. Visit our Order a Test page to order specimen-collection kits for your practice.
How do I obtain the results of a Foundation Medicine test?
Foundation Medicine test reports can be accessed as soon as results are ready via our digital reporting portal or our mobile app – log in or sign up for a Foundation Medicine account or download our iOS app to obtain access. You can also receive access to results via secure email or request to have results faxed to you by reaching out to our Client Services team at email@example.com or by phone at +1 (888) 988-3639.
Is your lab CLIA Certified and CAP Accredited?
All Foundation Medicine comprehensive genomic profiling tests are CAP Accredited, CLIA Certified, and New York State Department of Health (NYSDOH) Approved. View our certification documents here.
How do I sign-up for a Foundation Medicine account to order tests and access patient results online?
To sign-up for a Foundation Medicine account to place orders and access patient results online, complete the sign-up form here. To request access to our other online applications, such as FoundationInsights®, FoundationSmartTrialsTM, or our online biopharma resources, please contact your local Foundation Medicine representative or our Client Services department at firstname.lastname@example.org.
I’m having trouble logging in to my Foundation Medicine account – who do I contact to help?
For issues related to Foundation Medicine online accounts, please contact App Support at email@example.com.
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