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Test ID LUCSF LiquidHALLMARK CSF


Shipping Instructions


Freeze the specimen immediately following collection. It is critical that the specimen remains frozen throughout the shipping process and is never thawed.

 

The collected specimen is stable for up to 30 days if stored frozen at the collection site.



Necessary Information


1. Order questions are required for testing to proceed.

If not ordering electronically, submit LiquidHALLMARK Patient Information with the specimen.

2. A pathology report is recommended. Testing may proceed without this information; however, it aids in providing a more thorough and accurate interpretation of results. Ordering healthcare professionals are strongly encouraged to provide the information and send it with the specimen.



Specimen Required


Supplies: Sterile Specimen Tube, 6 mL (T485)

Container/Tube: Sterile tube

Specimen Volume: 5 mL

Collection Instructions:

1. Perform lumbar puncture and discard the first 1 mL to 2 mL of cerebrospinal fluid (CSF).

2. Collect CSF directly into a sterile tube.

3. Inspect specimen for visible discoloration. Specimen must be clear and colorless to perform testing.

4. Freeze sample upright prior to placing in transport container.

5. Send frozen.


Forms

If not ordering electronically, complete, print, and send a LiquidHALLMARK Patient Information with the specimen.

Useful For

Genomic profiling of suspected primary brain tumors or brain or leptomeningeal metastases for predicting prognosis and identifying matched targeted therapies or emerging resistance mechanisms

 

This test is not useful for prenatal screening.

Genetics Test Information

This test uses amplicon-based next-generation sequencing (NGS) to determine single nucleotide variants (SNVs, including cis-trans), deletions and insertions (delins), copy number variations (CNVs), and microsatellite instability (MSI). Circulating tumor DNA (ctDNA) is used to detect somatic (ie, tumor specific) mutations in 81 genes.

 

Note: This test is performed to evaluate for somatic (ie, tumor-specific) mutations. Although germline (ie, inherited) alterations may be detected, this test cannot distinguish between germline variants and somatic mutations with absolute certainty.

Highlights

LiquidHALLMARK CSF is a sensitive next-generation sequencing assay that targets circulating tumor DNA in cerebrospinal fluid (CSF) in patients with suspected brain or leptomeningeal metastases. It can detect driver mutations and emerging mutations of therapeutic resistance to inform physicians of the appropriate targeted treatment selection.

Method Name

Amplicon-Based Next-Generation Sequencing

Reporting Name

LiquidHALLMARK CSF

Specimen Type

CSF

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
CSF Frozen 30 days

Reference Values

An interpretive report will be provided

Day(s) Performed

Monday through Friday

Report Available

8 to 12 days

Performing Laboratory

Lucence Health, Inc.

Test Classification

This clinical test was developed and its performance characteristics determined by Lucence Health Inc. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes and should not be regarded as investigational or for research, unless otherwise stated in the report. Lucence Health Inc. is a Clinical Laboratory Improvement Amendments (CLIA)-certified clinical diagnostic laboratory (CLIA ID Number: 05D2200843) and is accredited to College of American Pathologists (CAP) laboratory quality standards.

CPT Code Information

81455

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LUCSF LiquidHALLMARK CSF Not Provided

 

Result ID Test Result Name Result LOINC Value
LU003 LiquidHALLMARK CSF Not Provided

NY State Approved

No