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Test Code FND1CSO FoundationOne CDx

Important Note

For internal ordering only. Not available to outreach clients.

Useful For

FoundationOne CDx (F1CDx) is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.  Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.

Synonyms/Keywords

Solid Tumors

FFPE

Formalin-fixed paraffin embedded

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Specimen Requirements

Fasting Required Specimen Type Preferred Container/Tube
No Varies

FoundationOne CDx Kit: Supplied in Specimen LabProcessing Department.

Refer to the Kit and the Collection Processing Instructions (below).

Acceptable Specimen Types

Formalin-fixed paraffin embedded (FFPE) specimens, including cut slide specimens.

Collection/Processing Instructions

Acceptable Samples:  Formalin-fixed paraffin embedded (FFPE) specimens, including cut slide specimens.  Use standard fixation methods to preserve nucleic acid integrity. 10% neutral-buffered formalin for 6-72 hours is industry standard. DO NOT use other fixatives (Bouins, B5, AZF, Holland's). DO NOT decalcify. 

 

When feasible, send the block + 1 H&E slide OR 10 unstained slides (positively charged and unbaked at 4-5 microns thick) + 1 H&E slide.

 

Surface area minimum: 25 mm2 (5 x 5 mm).  If sending slides, send 10 unstained slides cut at 4-5 microns thick to achieve a tissue volume of 1 mm3.  Specimens with smaller surface area may meet volume requirements by submitting additional unstained slides or blocks.  

  

Required Tumor Content:  OPTIMUM: 30% TN;     MINIMUM: 20% TN

 

Percent tumor nuclei (%TN) = number of tumor cells divided by total number of all cells with nuclei.

 

*NOTE for liver specimens: higher tumor content may be required because hepatocyte nuclei have twice the DNA content of other somatic nuclei.

Specimen Stability Information

Refer to Kit and Collection Processing Instructions

Rejection Criteria

Decalcified specimen
Specimen fixed with Bouins, B5, AZF, Holland's fixative

Test Components

Includes results from genomic signatures:

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Test Information

FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors. The test is designed to provide physicians with clinically actionable information both to consider appropriate therapies for patients and understand results with evidence of resistance based on the individual genomic profile of each patient's cancer. 

 

 Test results include microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions, and loss of heterozygosity (LOH) for ovarian cancer patients.  Testing can be reflexed from FoundationOne CDx to FoundationOneLiquid CDx if the tissue submitted does not meet the criteria for successful testing.

Interpretations

An interpretive report will be provided

Reference Range Information

An interpretive report will be provided

Performing Laboratory Name

Foundation Medicine

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #

150 Second Street 

Cambridge, MA 02141

 888-988-3639

https://www.foundationmedicine.com

https://www.foundationmedicine.com/test/foundationone-cdx

  

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Foundation Medicine, Inc   Sunday through Saturday 14 days Qualitative next generation sequencing

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
0037U   1 Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden.  

Ordering Applications

Ordering Application Description
COM FoundationOne CDx
Cerner FoundationOne CDx